A study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.

Study identifier:D2800C00001

ClinicalTrials.gov identifier:NCT01031836

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase II, Multicenter, Open-Label, Dose-Escalation Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Japanese Patients Who Have Systemic Lupus Erythematosus (SLE)

Medical condition

Systemic Lupus Erythematosus

Phase

Phase 2

Healthy volunteers

Study drug

MEDI-545, MEDI-545 600

Sex

All

Actual Enrollment

Study type

Interventional

Age

20 Years - 130 Years

Date

Study Start Date: 25 Nov 2009

Primary Completion Date: 07 Nov 2012

Study Completion Date: 11 Jul 2016

Study design

Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2018 by AstraZeneca

Collaborators

MedImmune

Inclusion and exclusion criteria

Location

Research Site

Sapporo-shi, Japan, 060-8638

Location

Research Site

Kawagoe-shi, Japan, 350-8550

Location

Research Site

Chiba-shi, Japan, 260-8712

Location

Research Site

Kanazawa-shi, Japan, 920-8650

Location

Research Site

Kitakyushu-shi, Japan, 807-8555

Location

Research Site

Fukuoka-shi, Japan, 810-8563

Location

Research Site

Shinjuku-ku, Japan, 160-8582

Arms	Assigned Interventions
Experimental: MEDI-545 1.0 mg/kg Cohort 1	Drug: MEDI-545 Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses.
Experimental: MEDI-545 3.0 mg/kg Cohort 2	Drug: MEDI-545 Stage I: MEDI-545 3.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 3.0 mg/kg IV once every 2 weeks for a total of 79 doses
Experimental: MEDI-545 10.0 mg/kg Cohort 3	Drug: MEDI-545 Stage I: MEDI-545 10.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 10.0 mg/kg IV once every 2 weeks for a total of 79 doses.
Experimental: MEDI-545 100 mg Cohort 4	Drug: MEDI-545 Stage I: MEDI-545 100 mg SC, on Day 1 and weekly or once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 100 mg SC once every 2 weeks for a total of 79 doses.
Experimental: MEDI-545 600 mg Cohort 5	Drug: MEDI-545 600 Stage I: MEDI-545 600 mg IV once every 4 weeks from Day 1 for a total of 8 doses. Stage II: MEDI-545 600 mg IV once every 4 weeks for a total of 40 doses.
Experimental: MEDI-545 1,200 mg Cohort 6	Drug: MEDI-545 Stage I: MEDI-545 1,200 mg IV once every 4 weeks from Day 1 for a total of 8 doses. Stage II: MEDI-545 1,200 mg IV once every 4 weeks for a total of 40 doses

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Tsutomu Takeuchi

Department of Internal Medicine School of Medicine Keio University

A study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Documents available

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator