Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants with Active, Moderate to Severe Crohn’s Disease
Study identifier:D5170C00002
ClinicalTrials.gov identifier:NCT02574637
EudraCT identifier:2015-000609-38
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
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
Medical condition
Crohn's disease
Phase
Phase 2
Healthy volunteers
No
Study drug
Brazikumab IV Infusion, Brazikumab IV Infusion, Brazikumab IV Infusion, Brazikumab IV Infusion, Brazikumab IV Infusion, Brazikumab SC Injection, Brazikumab SC Injection, Brazikumab SC Injection, Brazikumab SC Injection, Brazikumab SC Injection, Placebo, Placebo, Placebo, Placebo, Placebo
Sex
All
Actual enrollment
29
Study type
Interventional
Age
18 Years - 80 Years
Date
Study Start Date: 05 Jan 2016
Primary Completion Date: 28 Jul 2017
Study Completion Date: 29 Jan 2018
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 May 2021 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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. |
