A Study of MDX-1100 in Subjects With Active Ulcerative Colitis



Status:Completed
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2008
End Date:September 2009

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A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Subjects With Active Ulcerative Colitis

The purpose of this study is to determine the safety and tolerability of the MDX-1100
regimen in subjects with active Ulcerative colitis(UC) and determine the response rate at
day 57 in patients administered MDX-1100.


Inclusion Criteria:

- Subjects with active UC on either 5-ASA,corticosteroids,azathioprine(AZA) and
or/6-mercaptopurine(6-MP);

- Mayo score of 6 to 10 points with moderate to severe disease on endoscopy

- Subjects on the following medications;

1. prednisolone ≤ 20 mg daily (or equivalent) (dose must be stable for at least 2
weeks prior to study drug administration)

2. 5-ASA (dose must be stable for at least 4 weeks prior to study drug
administration)

3. AZA or 6-MP (dose must be stable for at least 3 months prior to study drug
administration)

4. Rectal steroids or 5-ASA (must have been stable for at least 4 weeks prior to
study drug)

Exclusion Criteria:

- Anti-TNF therapy within 8 weeks before study drug administration

- Contraindication to colonoscopy or sigmoidoscopy

- Primary or secondary immunodeficiency

- Autoimmune disease besides UC, with the exceptions of Sjogren's syndrome or
hypothyroidism

- History of malignancy, excluding adequately treated and cured basal or squamous cell
of the skin, or cervical carcinoma in situ

- Evidence of acute or chronic infection

- Clinically significant disease requiring medication
We found this trial at
8
sites
Dayton, Ohio 45415
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Dayton, OH
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1690 Dunlawton Ave # 220
Port Orange, Florida 32127
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Port Orange, FL
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Abbotsford,
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Chevy Chase, Maryland 20815
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Chevy Chase, MD
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Chicago, IL
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New York, New York 10029
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New York, NY
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St. Louis, Missouri 63108
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St. Louis, MO
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Tampa, FL
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