A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults with Idiopathic Pulmonary Fibrosis

Study identifier:CD-RI-CAT-354-1066

ClinicalTrials.gov identifier:NCT01629667

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults with Idiopathic Pulmonary Fibrosis

Medical condition

Idiopathic Pulmonary Fibrosis

Phase

Phase 2

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

409

Study type

Interventional

Age

50 Years - 79 Years

Date

Study Start Date: 01 Oct 2012

Primary Completion Date: 01 May 2015

Study Completion Date: 01 Jan 2016

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2017 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Tampa, FL, United States

Location

Research Site

Summit, NJ, United States

Location

Research Site

Windsor, ON, Canada

Location

Research Site

Phoenix, AZ, United States

Location

Research Site

McKinney, TX, United States

Location

Research Site

Louisville, KY, United States

Location

Research Site

Vancouver, BC, Canada

Location

Research Site

Prahran, Australia

Arms	Assigned Interventions
Experimental: Tralokinumab 400 milligram (mg) Participants will receive Tralokinumab 400 mg intravenous (IV) infusion Q4W for 68 Weeks.	Biological/Vaccine: Tralokinumab Participants will receive Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Experimental: Tralokinumab 800 mg Participants will receive Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.	Biological/Vaccine: Tralokinumab Participants will receive Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Placebo Comparator: Placebo Participants will receive placebo IV once every 4 Weeks (Q4W) for 68 Weeks.	Other: Placebo Participants will receive placebo IV once every 4 Weeks (Q4W) for 68 Weeks.

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 409 participants participated in the study. Of which, 176 participants were randomized into the study at 48 sites including 17 sites in the USA, 9 sites in Australia, 7 sites in Peru, 6 sites in Israel, 5 sites in Canada, and 4 sites in South Korea.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 176 participants were randomized into the study. Three participants who were randomized did not receive treatment; therefore, 173 participants were randomized and treated.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Participant Flow: Overall Study

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
STARTED	59	58	59
Randomized and treated	57	57	59
COMPLETED	12	17	14
NOT COMPLETED	47	41	45
Lost to Follow-up	0	1	1
Withdrawal by Subject	31	20	28
Death	1	5	3
Randomized, not treated	2	1	0
Ongoing AE worsening right heart failure	0	1	0
Requiring lung transplant	2	1	3
Early tretmt termntd, cmpltd safety f-up	9	11	8
Started other medicine	1	0	1
Site error in safety follow-up	0	0	1
Enrolled in another clinical study	0	1	0
Code break	1	0	0

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

The intent-to-treat (ITT) population is all randomized participants who receive any study investigational product and participants were analysed according to the randomization.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Baseline Measures

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg	Total
Number of Participants [units: Participants]	57	57	59	173
Age Continuous [units: Years] Mean ± Standard Deviation	67.5 ± 6.1	67.3 ± 7.7	67.9 ± 6.7	67.6 ± 6.8
Gender, Male/Female [units: Participants]
Female	12	15	13	40
Male	45	42	46	133

Outcome Measures

1. Primary Outcome Measure: Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52 [ Time Frame: Baseline and Week 52 ]

Measure Type	Primary
Measure Name	Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52
Measure Description	Forced vital capacity (FVC) is a standard pulmonary function test used to monitor disease progression in IPF. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%.
Time Frame	Baseline and Week 52
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52 [units: Percentage of predicted FVC] Mean (Standard Deviation)
Baseline (n=57,57,59)	70.30 (12.04)	68.54 (14.26)	70.60 (13.37)
Change at Week 52 (n=36,32,35)	-4.08 (6.85)	-6.10 (6.98)	-6.07 (5.14)

Statistical Analysis 1 for Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52

Groups^[1]	Placebo, Tralokinumab 400 milligram (mg)
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.140
Other^[5]	-1.77
95% Confidence Interval	( -4.13 to 0.59 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Additional details about a non-inferiority or equivalence analysis:
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[3]	Other relevant information, such as adjustments or degrees of freedom:
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[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[5]	Other relevant estimation information:
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Statistical Analysis 2 for Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52

Groups^[1]	Placebo, Tralokinumab 800 mg
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.234
Other^[5]	-1.41
95% Confidence Interval	( -3.73 to 0.91 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

2. Secondary Outcome Measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [ Time Frame: From the start of study treatment through Week 88 ]

Measure Type	Secondary
Measure Name	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Measure Description	Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received Tralokinumab. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pretreatment state.
Time Frame	From the start of study treatment through Week 88
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [units: Participant]
TEAE	53	50	57
TESAE	13	16	17

No statistical analysis provided for Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

3. Secondary Outcome Measure: Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events [ Time Frame: From the start of study treatment through Week 88 ]

Measure Type	Secondary
Measure Name	Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events
Measure Description	An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
Time Frame	From the start of study treatment through Week 88
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events [units: Participant]
Anaemia	1	0	1
Haemoglobin decreased	0	1	0
Hypovolaemia	1	0	0
ALT increased	0	0	1
AST increased	0	0	1
Blood glucose increased	0	0	1
Diabetes mellitus	2	0	0
Diabetes mellitus inadequate control	0	1	0
Type 2 diabetes mellitus	0	0	1
Gout	0	1	1
Hepatic steatosis	0	0	1
Liver function test abnormal	0	0	1
GGT increased	0	0	1
Hyperlipidaemia	0	0	1
Hyperglycaemia	1	0	0
Hypokalaemia	1	0	0
Hypertriglyceridaemia	1	0	0
Hyponatraemia	1	0	0
Hypophosphataemia	0	0	1
Iron deficiency	1	0	0
Vitamin D deficiency	0	1	0
Vitamin D decreased	0	0	1

No statistical analysis provided for Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events

4. Secondary Outcome Measure: Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events [ Time Frame: From the start of study treatment through Week 88 ]

Measure Type	Secondary
Measure Name	Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events
Measure Description	Vital signs parameters included heart rate, blood pressure, temperature, weight, pulse oximetry and respiratory rate. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame	From the start of study treatment through Week 88
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events [units: Participant]
Hypertension	2	1	2
Pulmonary hypertension	2	1	2
Pyrexia	1	1	2
Hypotension	1	1	1
Blood pressure increased	0	0	2
Atrial fibrillation	0	0	2
Atrial flutter	1	0	1
Arrhythmia	0	0	1
Bradycardia	1	0	0
Heart rate increased	0	0	1
Palpitations	0	0	1
Sinus tachycardia	1	0	0
Supraventricular tachycardia	1	0	0
Tachyarrhythmia	0	0	1
Weight decreased	4	5	3

No statistical analysis provided for Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events

5. Secondary Outcome Measure: Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events [ Time Frame: From the start of study treatment through Week 88 ]

Measure Type	Secondary
Measure Name	Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events
Measure Description	AEs observed in participants with clinically significant ECG abnormalities were assessed. Tricuspid valve incompetence was the only abnormality reported as TEAE. ECG parameters included heart rate, PR, QRS, QT, and QTc intervals. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame	From the start of study treatment through Week 88
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events [units: Participant]	1	0	1

No statistical analysis provided for Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events

6. Secondary Outcome Measure: Percentage of Participants with Disease Progression [ Time Frame: Week 52 and 72 ]

Measure Type	Secondary
Measure Name	Percentage of Participants with Disease Progression
Measure Description	Progression-free Survival (PFS) was used to evaluate disease progression and the percentage of participants with disease progression. A participant was classified as having disease progression if at least one of the following criteria were met:• Adjudicated respiratory-related mortality. •Adjudicated hospitalization due to IPF exacerbation. •Confirmed decline in percent-predicted FVC of greater than or equal to (>=) 10%. •Confirmed decline in 6 minute walk test (6MWT) >= 50 meters.
Time Frame	Week 52 and 72
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Percentage of Participants with Disease Progression [units: Percentage of Participant]
At Week 52	35.1	35.1	28.8
At Week 72	42.1	42.1	44.1

No statistical analysis provided for Percentage of Participants with Disease Progression

7. Secondary Outcome Measure: Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72 [ Time Frame: Baseline, Week 52 and 72 ]

Measure Type	Secondary
Measure Name	Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72
Measure Description	The single breath technique was used to determine the DLco. The test was performed by qualified pulmonary function technicians with experience performing this study. Acceptable test criteria included:• An inspiratory volume of more than 85% of vital capacity. • A stable breath hold of 10 seconds (+/- 2 seconds) with no leaks, Valsalva or Mueller maneuvers. • Expiration in less than 4 seconds with appropriate clearance of dead space. The average of the two best acceptable maneuvers was used. There must be a minimum of 4 minutes between the performances of each test.
Time Frame	Baseline, Week 52 and 72
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72 [units: Percent predicted DLco] Mean (Standard Deviation)
Baseline (n=57,57,59)	46.962 (13.796)	49.389 (16.029)	47.509 (12.524)
Change at Week 52 (n=34,30,32)	-3.963 (8.777)	-5.233 (9.597)	-6.356 (8.588)
Change at Week 72 (n=23,21,22)	-8.322 (9.538)	-9.962 (10.362)	-10.382 (12.372)

No statistical analysis provided for Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72

8. Secondary Outcome Measure: Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72 [ Time Frame: Baseline, Week 52 and 72 ]

Measure Type	Secondary
Measure Name	Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72
Measure Description	The 6MWT measures the distance that a participant can walk on a measured, flat hard surface in a period of 6 minutes. The 6MWT evaluates the global and integrated responses of all body systems involved during walking.
Time Frame	Baseline, Week 52 and 72
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72 [units: Meter] Mean (Standard Deviation)
Baseline (n=55,57,56)	391.07 (112.06)	391.69 (102.46)	383.22 (93.99)
Change at Week 52 (n=31,31,29)	19.49 (71.36)	22.96 (52.38)	-12.40 (55.81)
Change at Week 72 (n=21,24,19)	18.76 (54.83)	7.85 (78.12)	-30.25 (78.07)

No statistical analysis provided for Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72

9. Secondary Outcome Measure: Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68 [ Time Frame: Baseline and Week 68 ]

Measure Type	Secondary
Measure Name	Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68
Measure Description	Participants transcutaneous oxygen saturation were observed by pulse oximetry.
Time Frame	Baseline and Week 68
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68 [units: Percent of oxygen saturation] Mean (Standard Deviation)
Baseline (n=57,57,59)	96.2 (1.9)	95.6 (2.0)	95.4 (2.9)
Change at Week 52 (n=30,28,29)	-0.6 (2.3)	0.4 (1.7)	-0.7 (2.7)
Change at Week 68 (n=23,25,22)	-0.6 (1.8)	0.1 (2.4)	-1.0 (2.8)

No statistical analysis provided for Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68

10. Secondary Outcome Measure: Change From Baseline in Lung Volumes Through Week 72 [ Time Frame: Baseline, Week 52 and 72 ]

Measure Type	Secondary
Measure Name	Change From Baseline in Lung Volumes Through Week 72
Measure Description	Lung volumes were evaluated by total lung capacity (TLC), residual volume (RV), and vital capacity (VC). Lung volumes were determined by body plethysmography.
Time Frame	Baseline, Week 52 and 72
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Change From Baseline in Lung Volumes Through Week 72 [units: Liter] Mean (Standard Deviation)
Baseline (n=53,50,53)	4.105 (0.905)	3.870 (0.905)	4.060 (1.192)
Change at Week 52 (n=32,29,28)	0.891 (5.150)	-0.212 (0.645)	-0.264 (0.442)
Change at Week 72 (n=24,22,19)	-0.139 (0.635)	-0.274 (0.705)	-0.417 (0.468)

No statistical analysis provided for Change From Baseline in Lung Volumes Through Week 72

11. Secondary Outcome Measure: Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations [ Time Frame: Week 52 and 72 ]

Measure Type	Secondary
Measure Name	Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations
Measure Description	The IPF exacerbations is defined as an acute, clinically significant, deterioration of unidentifiable cause in a participant with underlying IPF. Exacerbations of IPF were adjudicated according to the protocol definition by an independent committee as follows: 1. Confirmed acute IPF exacerbation, 2. Suspected acute IPF exacerbation, 3. Not an IPF exacerbation with an alternative diagnosis provided if possible, and 4. Undetermined due to insufficient information.
Time Frame	Week 52 and 72
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations [units: Percentage of participant]
At Week 52	12.3	12.3	8.5
At Week 72	12.3	17.5	11.9

No statistical analysis provided for Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations

12. Secondary Outcome Measure: Percentage of Participants With Adjudicated Mortality [ Time Frame: Week 52 and 72 ]

Measure Type	Secondary
Measure Name	Percentage of Participants With Adjudicated Mortality
Measure Description	Participants all cause mortality were observed. Events that resulted in participant death were adjudicated into respiratory-related mortality or all other cause mortality by an independent committee.
Time Frame	Week 52 and 72
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Percentage of Participants With Adjudicated Mortality [units: Percentage of participant]
At Week 52	3.5	7.0	5.1
At Week 72	3.5	8.8	5.1

No statistical analysis provided for Percentage of Participants With Adjudicated Mortality

13. Secondary Outcome Measure: Percentage of Participants With Adjudicated Hospitalization [ Time Frame: Week 52 and 72 ]

Measure Type	Secondary
Measure Name	Percentage of Participants With Adjudicated Hospitalization
Measure Description	Participants who were hospitalized due to IPF exacerbation were observed. All events that resulted in the hospitalization of participants were adjudicated by an independent committee to determine if the event was due to an IPF exacerbation as follows: 1. Exacerbation or progression of IPF, 2. Result of a complication of IPF, 3. Not related to IPF (alternative diagnosis provided), and 4. Undetermined due to insufficient information.
Time Frame	Week 52 and 72
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Percentage of Participants With Adjudicated Hospitalization [units: Percentage of participant]
At Week 52	21.1	24.6	16.9
At Week 72	21.1	24.6	23.7

No statistical analysis provided for Percentage of Participants With Adjudicated Hospitalization

14. Secondary Outcome Measure: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72 [ Time Frame: Baseline, Week 52 and 72 ]

Measure Type	Secondary
Measure Name	Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72
Measure Description	FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.
Time Frame	Baseline, Week 52 and 72
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72 [units: Liter] Mean (Standard Deviation)
Baseline (n=57,57,59)	2.199 (0.500)	2.025 (0.495)	2.144 (0.564)
Change at Week 52 (n=36,32,35)	-0.120 (0.259)	-0.148 (0.200)	-0.179 (0.134)
Change at Week 72 (n=26,26,23)	-0.260 (0.261)	-0.152 (0.317)	-0.222 (0.166)

No statistical analysis provided for Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72

15. Secondary Outcome Measure: Change From Baseline in Percent-predicted FEV1 Through Week 72 [ Time Frame: Baseline, Week 52 and 72 ]

Measure Type	Secondary
Measure Name	Change From Baseline in Percent-predicted FEV1 Through Week 72
Measure Description	FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FEV1 = (observed value)/(predicted value) * 100%.
Time Frame	Baseline, Week 52 and 72
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Change From Baseline in Percent-predicted FEV1 Through Week 72 [units: Percent of predicted FEV1] Mean (Standard Deviation)
Baseline (n=57,57,59)	78.56 (13.05)	77.88 (14.88)	78.94 (14.58)
Change at Week 52 (n=36,32,35)	-4.16 (8.50)	-5.78 (8.11)	-7.01 (5.33)
Change at Week 72 (n=26,26,23)	-8.77 (8.99)	-6.42 (11.13)	-8.61 (6.61)

No statistical analysis provided for Change From Baseline in Percent-predicted FEV1 Through Week 72

16. Secondary Outcome Measure: Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72 [ Time Frame: Baseline, Week 52 and 72 ]

Measure Type	Secondary
Measure Name	Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72
Measure Description	Forced vital capacity (FVC) is a standard pulmonary function test used to monitor disease progression in IPF. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres.
Time Frame	Baseline, Week 52 and 72
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72 [units: Liter] Mean (Standard Deviation)
Baseline (n=57,57,59)	2.662 (0.649)	2.406 (0.664)	2.593 (0.711)
Change at Week 52 (n=36,32,35)	-0.162 (0.278)	-0.205 (0.224)	-0.209 (0.168)
Change at Week 72 (n=26,26,23)	-0.322 (0.297)	-0.186 (0.325)	-0.282 (0.242)

No statistical analysis provided for Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72

17. Secondary Outcome Measure: Number of Participants With Clinical Global Impression of Severity Scores [ Time Frame: Week 72 ]

Measure Type	Secondary
Measure Name	Number of Participants With Clinical Global Impression of Severity Scores
Measure Description	The CGI-S is a single, clinician completed, item designed to capture the clinician’s impression of the participants IPF severity. Clinicians were asked to consider their experience in this participant population and rate the overall IPF severity of the participant using a 5-point scale (1 = very mild, 5 = very severe).
Time Frame	Week 72
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "N" is number of participants analysed for this outcome measure.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	25	24	24
Number of Participants With Clinical Global Impression of Severity Scores [units: Participant]
Very mild	1	0	1
Mild	6	10	6
Moderate	16	10	11
Severe	0	3	5
Very severe	2	1	1

No statistical analysis provided for Number of Participants With Clinical Global Impression of Severity Scores

18. Secondary Outcome Measure: Number of Participants With Clinical Global Impression of Change Scores [ Time Frame: Week 72 ]

Measure Type	Secondary
Measure Name	Number of Participants With Clinical Global Impression of Change Scores
Measure Description	The CGI-C is a single, clinician completed, item designed to capture the clinicians overall impression of change in IPF severity from the baseline state at Screening. Clinicians were asked to rate the participants IPF severity relative to their state at baseline using a 7-point scale (-3 = very much worse, 0 = no change, about the same, 3 = very much improved).
Time Frame	Week 72
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "N" is number of participants analysed for this outcome measure.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	25	24	23
Number of Participants With Clinical Global Impression of Change Scores [units: Participant]
Very much improved	0	0	0
Much improved	1	0	3
Slightly improved	2	1	1
No change	12	13	8
Slightly worse	8	8	6
Much worse	1	2	4
Very much worse	1	0	1

No statistical analysis provided for Number of Participants With Clinical Global Impression of Change Scores

19. Secondary Outcome Measure: Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score at Week 72 [ Time Frame: Baseline and Week 72 ]

Measure Type	Secondary
Measure Name	Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score at Week 72
Measure Description	The UCSD SOBQ is a 24-item questionnaire designed to capture patient-reported shortness of breath. Respondents were asked to rate their breathlessness during 21 activities of daily living using a 6-point scale (0 = not at all breathless, 5 = maximally breathless or too breathless to do this activity). In addition to the 21 activity items, the UCSD SOBQ includes 3 additional questions about limitations due to shortness of breath, fear of harm from overexertion, and fear of shortness of breath. The UCSD SOBQ was scored by summing responses across all 24 items to form a total score. Scores range from 0-120 with higher scores indicative of greater shortness of breath.
Time Frame	Baseline and Week 72
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score at Week 72 [units: Units on a scale] Mean (Standard Deviation)
Baseline (n=56,55,58)	40.9 (22.8)	36.5 (21.0)	45.9 (20.4)
Change at Week 72 (n=24,21,21)	12.9 (14.7)	-0.4 (18.0)	10.9 (23.3)

No statistical analysis provided for Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score at Week 72

20. Secondary Outcome Measure: Change From Baseline in St. George’s Respiratory Questionnaire (SGRQ) Total Score at Week 72 [ Time Frame: Baseline and Week 72 ]

Measure Type	Secondary
Measure Name	Change From Baseline in St. George’s Respiratory Questionnaire (SGRQ) Total Score at Week 72
Measure Description	The SGRQ is a 50-item Patient-reported outcome (PRO) instrument developed to measure respiratory-related health status via 76 weighted responses. The SGRQ is divided into two parts. Part 1 asks respondents to consider the last 3 months and report on their respiratory symptoms using 5-point Likert scales. Part 2 asks respondents to consider their current state and respond to a series of dichotomous yes/no items related to their activities (activities that cause or were limited by breathlessness) and impacts (social functioning, psychological disturbances resulting from airways disease). Total scores and domain scores (symptoms, activities, and impact on daily life) were scored from 0-100, where lower scores indicate better health status.
Time Frame	Baseline and Week 72
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Change From Baseline in St. George’s Respiratory Questionnaire (SGRQ) Total Score at Week 72 [units: Units on a scale] Mean (Standard Deviation)
Baseline (n=57,57,59)	47.24 (18.86)	44.80 (18.91)	51.39 (15.64)
Change at Week 72 (n=24,24,23)	2.91 (14.92)	3.16 (15.11)	3.38 (14.88)

No statistical analysis provided for Change From Baseline in St. George’s Respiratory Questionnaire (SGRQ) Total Score at Week 72

21. Secondary Outcome Measure: Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72 [ Time Frame: Baseline, Week 52 and 72 ]

Measure Type	Secondary
Measure Name	Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72
Measure Description	The EXACT-IPF is a 14-item daily dairy used to capture the IPF related symptoms completed by the participants using an eDiary. The EXACT-IPF total score is the sum of all items ranged from 1 to 14. EXACT-IPF is an interval-level scale ranging from 0 to 100, where the higher scores indicate more severe condition. The EXACT-IPF used Likert scales (with 3 to 6 response options each) to capture participant reported IPF-related symptoms. The scores are the simple sum of item responses for each domain or single item.
Time Frame	Baseline, Week 52 and 72
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72 [units: Units on a scale] Mean (Standard Deviation)
Baseline (n=55,51,56)	16.24 (9.44)	15.87 (8.38)	17.89 (9.72)
Change at Week 52 (n=31,27,30)	1.47 (5.75)	1.61 (7.21)	1.40 (10.18)
Change at Week 72 (n=23,23,20)	1.95 (7.46)	0.63 (7.50)	1.81 (10.00)

No statistical analysis provided for Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72

22. Secondary Outcome Measure: Change From Baseline in European Quality of Life-5-Dimension 3 Level Version (EQ-5D-3L) (Including Visual Analog Scale [VAS]) at Week 72 [ Time Frame: Baseline and Week 72 ]

Measure Type	Secondary
Measure Name	Change From Baseline in European Quality of Life-5-Dimension 3 Level Version (EQ-5D-3L) (Including Visual Analog Scale [VAS]) at Week 72
Measure Description	The EQ-5D-3L is a standardized PRO used to capture respondent’s general health status. The questionnaire assesses 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 response options (no problem, some or moderate problems, and unable or extreme problems) that reflect increasing levels of difficulty. The questionnaire also includes a visual analog scale, where the participants were asked to rate their current health on a scale of 0-100, with 0 being the worst imaginable health state.
Time Frame	Baseline and Week 72
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Change From Baseline in European Quality of Life-5-Dimension 3 Level Version (EQ-5D-3L) (Including Visual Analog Scale [VAS]) at Week 72 [units: Units on a scale] Mean (Standard Deviation)
Baseline (n=57,57,59)	70.5 (19.1)	70.5 (18.1)	66.6 (14.9)
Change at Week 72 (n=24,24,23)	-3.0 (17.9)	2.5 (20.9)	0.6 (14.3)

No statistical analysis provided for Change From Baseline in European Quality of Life-5-Dimension 3 Level Version (EQ-5D-3L) (Including Visual Analog Scale [VAS]) at Week 72

23. Secondary Outcome Measure: Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) [ Time Frame: Week 72 ]

Measure Type	Secondary
Measure Name	Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF)
Measure Description	The PGI-S is a single-item, global assessment of participant-perceived IPF severity. The assessment was designed to capture participant perceived IPF-related health status. Participants rate their IPF severity using a 5-point scale (1 = very mild, 5 = very severe).
Time Frame	Week 72
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "N" is number of participants analysed for this outcome measure.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	23	21	15
Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) [units: Participant]
Very mild	2	2	1
Mild	8	5	6
Moderate	11	13	8
Severe	1	1	0
Very severe	1	0	0

No statistical analysis provided for Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF)

24. Secondary Outcome Measure: Number of Participants with Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) [ Time Frame: Week 72 ]

Measure Type	Secondary
Measure Name	Number of Participants with Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF)
Measure Description	The PGI-C is a single-item, global assessment designed to capture participant-perceived change in their IPF health condition using a 7-point scale (-3 = very much improved, 0 = no change, about the same, 3 = very much worse).
Time Frame	Week 72
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "N" is number of participants analysed for this outcome measure.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	7	11	14
Number of Participants with Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) [units: Participant]
Very much improved	0	0	0
Much improved	1	1	0
Slightly improved	1	4	4
No change	1	3	5
Slightly worse	3	2	3
Much worse	1	1	2
Very much worse	0	0	0

No statistical analysis provided for Number of Participants with Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF)

25. Secondary Outcome Measure: Mean Serum Concentration of Tralokinumab [ Time Frame: Predose, 0 hour, and 2 hour postdose on Week 0; predose on Week 4, 48, 72, 82 and 88 ]

Measure Type	Secondary
Measure Name	Mean Serum Concentration of Tralokinumab
Measure Description	The mean serum concentration of Tralokinumab were observed.
Time Frame	Predose, 0 hour, and 2 hour postdose on Week 0; predose on Week 4, 48, 72, 82 and 88
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Pharmacokinetic population included all participants who received at least one dose of tralokinumab and had at least one detectable trough (Weeks 4, 48 or 72 only) serum concentration measurement. Here, "n" is number of participants analysed at given time point.

Reporting Groups

	Description
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	59
Mean Serum Concentration of Tralokinumab [units: microgram per milliliter (mcg/ml)] Mean (Standard Deviation)
Week 0: predose (n=50,56)	3.520 (23.885)	6.151 (45.560)
Week 0: 0 hour postdose (n=53,57)	176.047 (125.991)	311.105 (88.229)
Week 0: 2 hour postdose (n=53,56)	172.108 (46.423)	301.321 (60.520)
Week 4 (n=57,57)	30.155 (20.164)	57.914 (45.326)
Week 48 (n=33,39)	44.653 (40.584)	80.553 (67.187)
Week 72 (n=24,21)	41.583 (24.723)	76.224 (54.045)
Week 82 (n=15,12)	3.651 (3.547)	11.442 (13.846)
Week 88 (n=12,10)	0.493 (0.490)	10.585 (19.084)

No statistical analysis provided for Mean Serum Concentration of Tralokinumab

26. Secondary Outcome Measure: Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab [ Time Frame: From the start of study treatment through Week 88 ]

Measure Type	Secondary
Measure Name	Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab
Measure Description	A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.
Time Frame	From the start of study treatment through Week 88
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received. Here, "n" is number of participants analysed at given time point.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Measured Values

	Placebo	Tralokinumab 400 milligram (mg)	Tralokinumab 800 mg
Number of Participants Analyzed [units:participants]	57	57	59
Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab [units: Percentage of participant]
Baseline (n=54,54,58)	1.9	1.9	0
Week 0, Day 1 (n=1,3,1)	0	0	0
Week 48 (n=35,32,36)	2.9	0	0
Week 72 (n=2,1,1)	0	0	0
Week 82 (n=13,15,12)	7.7	0	0
Week 88 (n=10,13,11)	20	0	0

No statistical analysis provided for Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab

Serious Adverse Events

Time Frame	From the start of study treatment through Week 88 or at the time of early termination from the study
Additional Description	No text entered.

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Serious Adverse Events

Placebo

Tralokinumab 400 milligram (mg)

Tralokinumab 800 mg

Total, serious adverse events

# participants affected / at risk

13/57 (22.81%)

16/57 (28.07%)

17/59 (28.81%)

Cardiac disorders

Angina pectoris¹,^†

# participants affected / at risk

0/57 (0.00%)

1/59 (1.69%)

# events

Cardiac disorders

Atrial flutter¹,^†

# participants affected / at risk

0/57 (0.00%)

1/59 (1.69%)

# events

Cardiac disorders

Cardiac arrest¹,^†

# participants affected / at risk

0/57 (0.00%)

1/57 (1.75%)

0/59 (0.00%)

# events

Cardiac disorders

Cardiac failure congestive¹,^†

# participants affected / at risk

1/57 (1.75%)

0/57 (0.00%)

0/59 (0.00%)

# events

Cardiac disorders

Right ventricular failure¹,^†

# participants affected / at risk

0/57 (0.00%)

1/57 (1.75%)

0/59 (0.00%)

# events

Cardiac disorders

Supraventricular tachycardia¹,^†

# participants affected / at risk

1/57 (1.75%)

0/57 (0.00%)

0/59 (0.00%)

# events

Cardiac disorders

Tachyarrhythmia¹,^†

# participants affected / at risk

0/57 (0.00%)

1/59 (1.69%)

# events

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

0/57 (0.00%)

1/59 (1.69%)

# events

Gastrointestinal disorders

Inguinal hernia¹,^†

# participants affected / at risk

1/57 (1.75%)

0/57 (0.00%)

0/59 (0.00%)

# events

Gastrointestinal disorders

Rectal haemorrhage¹,^†

# participants affected / at risk

1/57 (1.75%)

0/57 (0.00%)

0/59 (0.00%)

# events

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

0/57 (0.00%)

1/59 (1.69%)

# events

General disorders and administration site conditions

Chest pain¹,^†

# participants affected / at risk

0/57 (0.00%)

1/57 (1.75%)

0/59 (0.00%)

# events

General disorders and administration site conditions

Multi-organ failure¹,^†

# participants affected / at risk

1/57 (1.75%)

0/57 (0.00%)

0/59 (0.00%)

# events

General disorders and administration site conditions

Peripheral swelling¹,^†

# participants affected / at risk

1/57 (1.75%)

0/57 (0.00%)

0/59 (0.00%)

# events

Infections and infestations

Appendiceal abscess¹,^†

# participants affected / at risk

0/57 (0.00%)

1/59 (1.69%)

# events

Infections and infestations

Appendicitis¹,^†

# participants affected / at risk

0/57 (0.00%)

1/57 (1.75%)

0/59 (0.00%)

# events

Infections and infestations

Atypical pneumonia¹,^†

# participants affected / at risk

0/57 (0.00%)

1/57 (1.75%)

0/59 (0.00%)

# events

Infections and infestations

Bronchitis¹,^†

# participants affected / at risk

0/57 (0.00%)

1/59 (1.69%)

# events

Infections and infestations

Haemophilus infection¹,^†

# participants affected / at risk

1/57 (1.75%)

0/57 (0.00%)

0/59 (0.00%)

# events

Infections and infestations

Pharyngitis¹,^†

# participants affected / at risk

0/57 (0.00%)

1/57 (1.75%)

0/59 (0.00%)

# events

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

2/57 (3.51%)

6/57 (10.53%)

2/59 (3.39%)

# events

Infections and infestations

Post procedural sepsis¹,^†

# participants affected / at risk

0/57 (0.00%)

1/57 (1.75%)

0/59 (0.00%)

# events

Infections and infestations

Sepsis¹,^†

# participants affected / at risk

0/57 (0.00%)

1/59 (1.69%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

0/57 (0.00%)

1/59 (1.69%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

1/57 (1.75%)

0/57 (0.00%)

0/59 (0.00%)

# events

Injury, poisoning and procedural complications

Concussion¹,^†

# participants affected / at risk

0/57 (0.00%)

1/57 (1.75%)

0/59 (0.00%)

# events

Injury, poisoning and procedural complications

Facial bones fracture¹,^†

# participants affected / at risk

0/57 (0.00%)

1/57 (1.75%)

0/59 (0.00%)

# events

Injury, poisoning and procedural complications

Joint dislocation¹,^†

# participants affected / at risk

0/57 (0.00%)

1/59 (1.69%)

# events

Metabolism and nutrition disorders

Dehydration¹,^†

# participants affected / at risk

0/57 (0.00%)

1/59 (1.69%)

# events

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

0/57 (0.00%)

1/59 (1.69%)

# events

Musculoskeletal and connective tissue disorders

Osteoarthritis¹,^†

# participants affected / at risk

0/57 (0.00%)

1/57 (1.75%)

0/59 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Spinal osteoarthritis¹,^†

# participants affected / at risk

0/57 (0.00%)

1/57 (1.75%)

0/59 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenocarcinoma gastric¹,^†

# participants affected / at risk

0/57 (0.00%)

1/59 (1.69%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung adenocarcinoma¹,^†

# participants affected / at risk

0/57 (0.00%)

1/57 (1.75%)

0/59 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant melanoma¹,^†

# participants affected / at risk

0/57 (0.00%)

1/59 (1.69%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to adrenals¹,^†

# participants affected / at risk

0/57 (0.00%)

1/57 (1.75%)

0/59 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of skin¹,^†

# participants affected / at risk

1/57 (1.75%)

0/57 (0.00%)

0/59 (0.00%)

# events

Nervous system disorders

Cerebral infarction¹,^†

# participants affected / at risk

0/57 (0.00%)

1/59 (1.69%)

# events

Nervous system disorders

Cerebrovascular accident¹,^†

# participants affected / at risk

1/57 (1.75%)

0/57 (0.00%)

1/59 (1.69%)

# events

Nervous system disorders

Syncope¹,^†

# participants affected / at risk

2/57 (3.51%)

0/59 (0.00%)

# events

Renal and urinary disorders

Dysuria¹,^†

# participants affected / at risk

1/57 (1.75%)

0/57 (0.00%)

0/59 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease¹,^†

# participants affected / at risk

0/57 (0.00%)

1/57 (1.75%)

0/59 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

0/57 (0.00%)

2/59 (3.39%)

# events

Respiratory, thoracic and mediastinal disorders

Idiopathic pulmonary fibrosis¹,^†

# participants affected / at risk

4/57 (7.02%)

7/57 (12.28%)

4/59 (6.78%)

# events

Respiratory, thoracic and mediastinal disorders

Pneumothorax¹,^†

# participants affected / at risk

0/57 (0.00%)

1/59 (1.69%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism¹,^†

# participants affected / at risk

1/57 (1.75%)

0/59 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary hypertension¹,^†

# participants affected / at risk

1/57 (1.75%)

0/57 (0.00%)

0/59 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Respiratory distress¹,^†

# participants affected / at risk

1/57 (1.75%)

0/57 (0.00%)

0/59 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Respiratory failure¹,^†

# participants affected / at risk

1/57 (1.75%)

0/57 (0.00%)

1/59 (1.69%)

# events

Skin and subcutaneous tissue disorders

Drug eruption¹,^†

# participants affected / at risk

0/57 (0.00%)

1/57 (1.75%)

0/59 (0.00%)

# events

Skin and subcutaneous tissue disorders

Pruritus allergic¹,^†

# participants affected / at risk

0/57 (0.00%)

1/57 (1.75%)

0/59 (0.00%)

# events

Skin and subcutaneous tissue disorders

Psoriasis¹,^†

# participants affected / at risk

1/57 (1.75%)

0/57 (0.00%)

0/59 (0.00%)

# events

Skin and subcutaneous tissue disorders

Rash maculo-papular¹,^†

# participants affected / at risk

0/57 (0.00%)

1/57 (1.75%)

0/59 (0.00%)

# events

Vascular disorders

Deep vein thrombosis¹,^†

# participants affected / at risk

1/57 (1.75%)

0/57 (0.00%)

0/59 (0.00%)

# events

Vascular disorders

Haematoma¹,^†

# participants affected / at risk

0/57 (0.00%)

1/57 (1.75%)

0/59 (0.00%)

# events

Vascular disorders

Thrombophlebitis¹,^†

# participants affected / at risk

1/57 (1.75%)

0/57 (0.00%)

0/59 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 18.1

Other Adverse Events

Time Frame	From the start of study treatment through Week 88 or at the time of early termination from the study
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	2%

Reporting Groups

	Description
Placebo	Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 milligram (mg)	Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg	Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Other Adverse Events

Placebo

Tralokinumab 400 milligram (mg)

Tralokinumab 800 mg

Total, other (not including serious) adverse events

# participants affected / at risk

51/57 (89.47%)

45/57 (78.95%)

50/59 (84.75%)

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

4/57 (7.02%)

3/57 (5.26%)

3/59 (5.08%)

# events

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

6/57 (10.53%)

4/57 (7.02%)

9/59 (15.25%)

# events

Gastrointestinal disorders

Dry mouth¹,^†

# participants affected / at risk

1/57 (1.75%)

2/57 (3.51%)

1/59 (1.69%)

# events

Gastrointestinal disorders

Gastrooesophageal reflux disease¹,^†

# participants affected / at risk

1/57 (1.75%)

2/59 (3.39%)

# events

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

4/57 (7.02%)

3/57 (5.26%)

6/59 (10.17%)

# events

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

3/57 (5.26%)

1/57 (1.75%)

3/59 (5.08%)

# events

General disorders and administration site conditions

Asthenia¹,^†

# participants affected / at risk

0/57 (0.00%)

4/59 (6.78%)

# events

General disorders and administration site conditions

Fatigue¹,^†

# participants affected / at risk

4/57 (7.02%)

5/57 (8.77%)

11/59 (18.64%)

# events

General disorders and administration site conditions

Oedema peripheral¹,^†

# participants affected / at risk

4/57 (7.02%)

3/57 (5.26%)

3/59 (5.08%)

# events

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

1/57 (1.75%)

2/59 (3.39%)

# events

Infections and infestations

Bronchitis¹,^†

# participants affected / at risk

5/57 (8.77%)

7/57 (12.28%)

5/59 (8.47%)

# events

Infections and infestations

Herpes zoster¹,^†

# participants affected / at risk

3/57 (5.26%)

1/57 (1.75%)

2/59 (3.39%)

# events

Infections and infestations

Influenza¹,^†

# participants affected / at risk

3/57 (5.26%)

0/57 (0.00%)

1/59 (1.69%)

# events

Infections and infestations

Lower respiratory tract infection¹,^†

# participants affected / at risk

4/57 (7.02%)

3/57 (5.26%)

5/59 (8.47%)

# events

Infections and infestations

Nasopharyngitis¹,^†

# participants affected / at risk

6/57 (10.53%)

5/59 (8.47%)

# events

Infections and infestations

Pharyngitis¹,^†

# participants affected / at risk

2/57 (3.51%)

6/57 (10.53%)

3/59 (5.08%)

# events

Infections and infestations

Respiratory tract infection¹,^†

# participants affected / at risk

4/57 (7.02%)

1/57 (1.75%)

3/59 (5.08%)

# events

Infections and infestations

Sinusitis¹,^†

# participants affected / at risk

6/57 (10.53%)

1/57 (1.75%)

4/59 (6.78%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

7/57 (12.28%)

10/57 (17.54%)

11/59 (18.64%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

3/57 (5.26%)

4/59 (6.78%)

# events

Infections and infestations

Viral upper respiratory tract infection¹,^†

# participants affected / at risk

3/57 (5.26%)

1/57 (1.75%)

1/59 (1.69%)

# events

Injury, poisoning and procedural complications

Infusion related reaction¹,^†

# participants affected / at risk

1/57 (1.75%)

2/57 (3.51%)

4/59 (6.78%)

# events

Injury, poisoning and procedural complications

Laceration¹,^†

# participants affected / at risk

4/57 (7.02%)

0/57 (0.00%)

0/59 (0.00%)

# events

Investigations

Weight decreased¹,^†

# participants affected / at risk

4/57 (7.02%)

5/57 (8.77%)

3/59 (5.08%)

# events

Metabolism and nutrition disorders

Decreased appetite¹,^†

# participants affected / at risk

3/57 (5.26%)

2/57 (3.51%)

6/59 (10.17%)

# events

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

1/57 (1.75%)

8/57 (14.04%)

2/59 (3.39%)

# events

Musculoskeletal and connective tissue disorders

Back pain¹,^†

# participants affected / at risk

5/57 (8.77%)

0/57 (0.00%)

2/59 (3.39%)

# events

Musculoskeletal and connective tissue disorders

Flank pain¹,^†

# participants affected / at risk

2/57 (3.51%)

1/57 (1.75%)

1/59 (1.69%)

# events

Musculoskeletal and connective tissue disorders

Muscle spasms¹,^†

# participants affected / at risk

1/57 (1.75%)

3/59 (5.08%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal chest pain¹,^†

# participants affected / at risk

0/57 (0.00%)

4/57 (7.02%)

4/59 (6.78%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal pain¹,^†

# participants affected / at risk

4/57 (7.02%)

3/57 (5.26%)

1/59 (1.69%)

# events

Musculoskeletal and connective tissue disorders

Myalgia¹,^†

# participants affected / at risk

2/57 (3.51%)

5/57 (8.77%)

4/59 (6.78%)

# events

Musculoskeletal and connective tissue disorders

Neck pain¹,^†

# participants affected / at risk

2/57 (3.51%)

0/57 (0.00%)

2/59 (3.39%)

# events

Musculoskeletal and connective tissue disorders

Pain in extremity¹,^†

# participants affected / at risk

4/57 (7.02%)

2/59 (3.39%)

# events

Nervous system disorders

Dizziness¹,^†

# participants affected / at risk

4/57 (7.02%)

3/57 (5.26%)

6/59 (10.17%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

8/57 (14.04%)

6/57 (10.53%)

5/59 (8.47%)

# events

Nervous system disorders

Lethargy¹,^†

# participants affected / at risk

2/57 (3.51%)

1/59 (1.69%)

# events

Nervous system disorders

Syncope¹,^†

# participants affected / at risk

2/57 (3.51%)

0/57 (0.00%)

2/59 (3.39%)

# events

Psychiatric disorders

Anxiety¹,^†

# participants affected / at risk

3/57 (5.26%)

0/57 (0.00%)

3/59 (5.08%)

# events

Psychiatric disorders

Depression¹,^†

# participants affected / at risk

3/57 (5.26%)

0/57 (0.00%)

1/59 (1.69%)

# events

Psychiatric disorders

Insomnia¹,^†

# participants affected / at risk

8/57 (14.04%)

2/57 (3.51%)

4/59 (6.78%)

# events

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

13/57 (22.81%)

10/57 (17.54%)

17/59 (28.81%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

2/57 (3.51%)

4/57 (7.02%)

10/59 (16.95%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea exertional¹,^†

# participants affected / at risk

1/57 (1.75%)

3/57 (5.26%)

4/59 (6.78%)

# events

Respiratory, thoracic and mediastinal disorders

Epistaxis¹,^†

# participants affected / at risk

2/57 (3.51%)

0/57 (0.00%)

4/59 (6.78%)

# events

Respiratory, thoracic and mediastinal disorders

Haemoptysis¹,^†

# participants affected / at risk

2/57 (3.51%)

1/57 (1.75%)

1/59 (1.69%)

# events

Respiratory, thoracic and mediastinal disorders

Idiopathic pulmonary fibrosis¹,^†

# participants affected / at risk

9/57 (15.79%)

8/57 (14.04%)

6/59 (10.17%)

# events

Respiratory, thoracic and mediastinal disorders

Oropharyngeal pain¹,^†

# participants affected / at risk

3/57 (5.26%)

1/57 (1.75%)

3/59 (5.08%)

# events

Respiratory, thoracic and mediastinal disorders

Productive cough¹,^†

# participants affected / at risk

1/57 (1.75%)

5/59 (8.47%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary hypertension¹,^†

# participants affected / at risk

1/57 (1.75%)

2/59 (3.39%)

# events

Respiratory, thoracic and mediastinal disorders

Rhinitis allergic¹,^†

# participants affected / at risk

3/57 (5.26%)

1/57 (1.75%)

2/59 (3.39%)

# events

Respiratory, thoracic and mediastinal disorders

Rhinorrhoea¹,^†

# participants affected / at risk

1/57 (1.75%)

2/57 (3.51%)

3/59 (5.08%)

# events

Respiratory, thoracic and mediastinal disorders

Upper-airway cough syndrome¹,^†

# participants affected / at risk

2/57 (3.51%)

0/57 (0.00%)

2/59 (3.39%)

# events

Skin and subcutaneous tissue disorders

Pruritus¹,^†

# participants affected / at risk

0/57 (0.00%)

3/57 (5.26%)

1/59 (1.69%)

# events

Skin and subcutaneous tissue disorders

Rash¹,^†

# participants affected / at risk

7/57 (12.28%)

3/57 (5.26%)

5/59 (8.47%)

# events

Vascular disorders

Haematoma¹,^†

# participants affected / at risk

0/57 (0.00%)

4/57 (7.02%)

0/59 (0.00%)

# events

Vascular disorders

Hypertension¹,^†

# participants affected / at risk

2/57 (3.51%)

1/57 (1.75%)

2/59 (3.39%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 18.1

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was early terminated due to lack of efficacy.

Results Point of Contact

Name/Title:	AstraZeneca Clinical Study Information Center
Organization:	MedImmune, LLC
Phone	1-877-240-9479
E-mail:	[email protected]

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

null Call Center

1-855-498-5565

Investigators

Principal Investigator

Joseph Parker

MedImmune, LLC

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site