Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's Disease

• Status: Terminated
• Trial end date: 2018-01-29
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 2b study to evaluate the efficacy and safety of brazikumab (MEDI2070) in participants with moderate to severe Crohn's disease who have failed or are intolerant to anti-tumor necrosis factor-alpha (anti-TNFα) therapy.

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

Details

• Lead Sponsor: AstraZeneca; MedImmune LLC
• Collaborator: AstraZeneca
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Diagnosis of ileal, ileo-colonic, or colonic Crohn's Disease (CD) for > 3 months prior to screening

• Men or women age 18 - 80 years at the time of screening

• Moderate to severely active CD, as defined by Crohn's Disease Activity Index (CDAI) and endoscopic demonstration of inflammation

• Stable dose of medications for Crohn's disease therapy

• Prior treatment failure or intolerance with at least one Anti-Tumor Necrosis Factor-Alpha Therapy (anti-TNF α) agent

• Effective contraception from screening, and for 36 weeks after the last dose of investigational product

• No known history of active tuberculosis (TB) & negative assessment for TB/latent TB

Exclusion Criteria:

• Severe underlying immunosuppression

• Severe gastrointestinal complications; e.g., short bowel syndromes, obstructing strictures, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation

• Significant infections at screening; Infected abscess, positive for Clostridium difficile, recent infectious hospitalization

• Recent treatment with approved or investigational biologic therapy for Crohn's disease

• Recent or planned live attenuated vaccine

• History of cancer, except for basal cell carcinoma or carcinoma in situ (CIS) of the cervix with apparent cure ≥ 12 months before screening

• Pregnancy/breast feeding

• Drug abuse