Conditions: Crohn's Disease
Keywords: MEDI2070 inflammatory bowel disease moderate to severe Crohn's disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 121
Healthy volunteers: no

Brief summary:
The study is designed to evaluate the clinical efficacy and safety of MEDI2070 as compared to placebo. Investigational product will be administered as intravenous infusion in double-blind period, and as a subcutaneous injection in open-label period

Detailed description:
This is a two-part Phase 2a study compromising a 12-week, double-blind, placebo-controlled, treatment period followed by a 100-week, open label, treatment period to evaluate short-term efficacy, and the short- and long-term safety of MEDI2070 in subjects with moderate to severe, active CD who have failed or are intolerant to anti-TNFα therapy as determined by the investigator. Approximately 120 subjects will be randomized in a 1:1 ratio to initially receive a fixed IV dose of MEDI2070 or placebo on Week 0(Day1) and Week 4 (Day 29) during the 12-week, double-blind, placebo-controlled, treatment period. At the completion of the double-blind, placebo-controlled, treatment period (Week 12), subjects will have the option to enter a 100-week, open-label, treatment period where they will receive open-label MEDI2070 (SC) Q4W (Week 12 through Week 112). Subjects will be followed for safety at 3 visits over 28 weeks after their last dose of IP. Subjects will also be contacted by phone 36 weeks after their last dose of IP for safety.

Arms:
arm 1: MEDI2070 iv infusion arm 2: placebo iv infusion arm 3: MEDI2070 sc injection; open-label arm is available for all subjects upon completion of first placebo-controlled treatment period

Interventions: intervention 1: MEDI2070 intervention 2: placebo
Intervention descriptions: intervention 1: 1 iv infusion on Week 0 and Week 4 intervention 2: 1 iv infusion on Week 0 and Week 4

Protocol document: