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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT02574637

Run by

AstraZeneca

People needed

29

Starts

2016-01-05

Expected to finish

2018-01-29

Last updated by the study team

2021-05-26

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Phoenix, Arizona, United States
• South Denver Gastroenterology, PC — Lone Tree, Colorado, United States
• Research Site — Lone Tree, Colorado, United States
• Clinical Research of West Florida - Corporate — Clearwater, Florida, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Advanced Pharma CR, LLC — Miami, Florida, United States
• Research Site — Miami, Florida, United States
• IMIC, Inc. — Palmetto Bay, Florida, United States
• Research Site — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• Research Site — Evanston, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Research Site — Indianapolis, Indiana, United States
• Cotton-O'Neil Clinical Research Center, Digestive Health — Topeka, Kansas, United States
• Research Site — Topeka, Kansas, United States
• Graves Gilbert Clinic — Bowling Green, Kentucky, United States
• Research Site — Bowling Green, Kentucky, United States
• Research Site — Louisville, Kentucky, United States
• University of Louisville — Louisville, Kentucky, United States
• Clinical Trials of SW Louisiana, LLC — Lake Charles, Louisiana, United States
• Research Site — Lake Charles, Louisiana, United States
• Clinical Trials Management, LLC — Metairie, Louisiana, United States
• Arizona Arthritis & Rheumatology Research, PLLC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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