Study identifier:D5170C00002
ClinicalTrials.gov identifier:NCT02574637
EudraCT identifier:2015-000609-38
CTIS identifier:N/A
A Phase 2b Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy
Crohn's disease
Phase 2
No
Brazikumab IV Infusion, Brazikumab SC Injection, Placebo
All
29
Interventional
18 Years - 80 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 May 2021 by AstraZeneca
AstraZeneca
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A Phase 2b study to evaluate the efficacy and safety of brazikumab (MEDI2070) in participants with moderate to severe Crohn’s disease who have failed or are intolerant to anti-tumor necrosis factor-alpha (anti-TNFα) therapy.
This is a four-part Phase 2b study comprised of a 16-week, double-blind, placebo-controlled, Induction Period, a 12-week double-blind, placebo-controlled, Maintenance Period, a 24-week, Open-label Period and a post-treatment 28 week observational safety follow-up period designed to evaluate the short-term efficacy and the short- and long term safety of brazikumab in participants with moderate to severe, active Crohn's disease (CD) who have failed or are intolerant to anti-TNFα therapy as determined by the Investigator.
Location
Location
Belton, MO, United States, 64012
Location
Wauwatosa, WI, United States, 53226
Location
Bowling Green, KY, United States, 42101
Location
Topeka, KS, United States, 66606
Location
Houston, TX, United States, 77098
Location
Poughkeepsie, NY, United States, 12601
Location
Metairie, LA, United States, 70006
Location
Chicago, IL, United States, 60637
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Placebo Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period. | Drug: Brazikumab IV Infusion Brazikumab IV infusion as per protocol specified dosing schedule. Other Name: MEDI2070 Drug: Brazikumab SC Injection Brazikumab IV infusion as per protocol specified dosing schedule. Other Name: MEDI2070 Drug: Placebo Placebo-matching Brazikumab IV infusion as per protocol specified dosing schedule. |
Experimental: Brazikumab High Dose Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48. | Drug: Brazikumab IV Infusion Brazikumab IV infusion as per protocol specified dosing schedule. Other Name: MEDI2070 Drug: Brazikumab SC Injection Brazikumab IV infusion as per protocol specified dosing schedule. Other Name: MEDI2070 Drug: Placebo Placebo-matching Brazikumab IV infusion as per protocol specified dosing schedule. |
Experimental: Brazikumab High-Medium Dose Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48. | Drug: Brazikumab IV Infusion Brazikumab IV infusion as per protocol specified dosing schedule. Other Name: MEDI2070 Drug: Brazikumab SC Injection Brazikumab IV infusion as per protocol specified dosing schedule. Other Name: MEDI2070 Drug: Placebo Placebo-matching Brazikumab IV infusion as per protocol specified dosing schedule. |
Experimental: Brazikumab Low-Medium Dose Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period. | Drug: Brazikumab IV Infusion Brazikumab IV infusion as per protocol specified dosing schedule. Other Name: MEDI2070 Drug: Brazikumab SC Injection Brazikumab IV infusion as per protocol specified dosing schedule. Other Name: MEDI2070 Drug: Placebo Placebo-matching Brazikumab IV infusion as per protocol specified dosing schedule. |
Experimental: Brazikumab Low Dose Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period. | Drug: Brazikumab IV Infusion Brazikumab IV infusion as per protocol specified dosing schedule. Other Name: MEDI2070 Drug: Brazikumab SC Injection Brazikumab IV infusion as per protocol specified dosing schedule. Other Name: MEDI2070 Drug: Placebo Placebo-matching Brazikumab IV infusion as per protocol specified dosing schedule. |
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