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

Completed · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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

Key facts

Study ID

NCT01714726

Run by

AstraZeneca

People needed

121

Starts

2013-02-01

Expected to finish

2016-12-14

Last updated by the study team

2021-05-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Pregnant or breastfeeding women.
• Presence of ileostomy and/or colostomy.
• Short bowel syndrome.
• Bowel perforation or obstruction.
• History of cancer.

Where it is running

• Research Site — Los Angeles, California, United States
• Research Site — San Diego, California, United States
• Research Site — Torrance, California, United States
• Research Site — Lakewood, Colorado, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Winter Park, Florida, United States
• Research Site — Macon, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Baton Rouge, Louisiana, United States
• Research Site — Hammond, Louisiana, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Chevy Chase, Maryland, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Troy, Michigan, United States
• Research Site — Belton, Missouri, United States
• Research Site — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — Asheville, North Carolina, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Lima, Ohio, United States
• Research Site — Germantown, Tennessee, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Encinitas, California, United States

Full record on ClinicalTrials.gov

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