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



Status:Completed
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 65
Updated:3/8/2019
Start Date:February 1, 2013
End Date:December 14, 2016

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A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy

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

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.

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.
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Chula Vista, California 91910
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
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610 3rd St # 206
Macon, Georgia 31201
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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701 West Morse Boulevard
Winter Park, Florida 32789
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207 Fletcher Street
Ann Arbor, Michigan 48109
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Belton, Missouri 64012
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Charlotte, North Carolina 28207
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Chevy Chase, Maryland 20815
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
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8540 112 Street Northwest
Edmonton, Alberta T6G 2L7
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7760 West 38th Avenue
Lakewood, Colorado 80215
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New York, New York 10065
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Troy, Michigan 48098
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