Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.

• Status: Completed
• Trial end date: 2016-12-14
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: MedImmune Ltd

Criteria

Inclusion Criteria:

• Diagnosed ileal, ileo-colonic, or colonic CD at least 6 months prior to screening.

• Men or women age 18 - 65 years at the time of screening.

• Moderate-sever active Crohn's Disease (CD), defined by a Crohn's Disease Activity Index (CDAI) score higher or equal 220 and lower or equal 450 at Day 1.

• No known history of active tuberculosis (TB).

• Received at least one anti-TNFα agent for the treatment of CD and did not initially respond.

Exclusion Criteria:

• Pregnant or breastfeeding women.

• Presence of ileostomy and/or colostomy.

• Short bowel syndrome.

• Bowel perforation or obstruction.

• History of cancer.