Evaluation of Efficacy and Safety of MEDI2070 in Subjects With Active, Moderate to Severe Crohn's Disease



Status:Terminated
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:7/28/2018
Start Date:January 5, 2016
End Date:January 29, 2018

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A Phase 2b Double-Blind, Multi-Dose, Placebo-Controlled 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

A Phase 2b 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

This is a four-part Phase 2b study comprised of a 16-week, double-blind, placebo-controlled,
Induction Period, a 12-week double-blind, placebo-controlled, Maintenance Period, a 24-week,
Open-label Period and a post-treatment 28 week observational safety follow-up period designed
to evaluate the 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.

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 CIS of the cervix with apparent
cure ≥ 12 months before screening

- Pregnancy/breast feeding

- Drug abuse
We found this trial at
28
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Belton, Missouri 64012
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Bowling Green, Kentucky 42101
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Chattanooga, Tennessee 37403
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Clearwater, FL
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Dayton, OH
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Evanston, IL
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Great Neck, New York 11021
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Lake Charles, Louisiana 70601
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Lone Tree, Colorado
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
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Metairie, Louisiana 70006
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Miami, Florida 33175
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2645 North Mayfair Road
Milwaukee, Wisconsin 53226
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Palmetto Bay, Florida
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243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Sayre, Pennsylvania 18840
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Southfield, Michigan 48034
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2401 South 31st Street
Temple, Texas 76508
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Topeka, KS
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Woolloongabba, Queensland 4102
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