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Terminated/Withdrawn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 SC Injection, 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. |
