Study identifier:D5170C00001
ClinicalTrials.gov identifier:NCT01714726
EudraCT identifier:2012-004098-26
CTIS identifier:N/A
A Phase 2a 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
MEDI2070, placebo
All
121
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 May 2021 by AstraZeneca
AstraZeneca
MedImmune Ltd
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: 1 MEDI2070 iv infusion | Drug: MEDI2070 1 iv infusion on Week 0 and Week 4 Drug: MEDI2070 1 iv infusion on Week 0 and Week 4 |
Placebo Comparator: 2 placebo iv infusion | Drug: placebo 1 iv infusion on Week 0 and Week 4 |
Experimental: open-label MEDI2070 sc injection; open-label arm is available for all subjects upon completion of first placebo-controlled treatment period | Drug: MEDI2070 1 iv infusion on Week 0 and Week 4 Drug: MEDI2070 1 iv infusion on Week 0 and Week 4 |