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 |
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.
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
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303 E Chicago Ave
Chicago, Illinois 60611
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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