Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease
| Status: | Terminated |
|---|---|
| Conditions: | Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/26/2018 |
| Start Date: | June 2012 |
| End Date: | December 2013 |
A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-945429 in Subjects With Moderate to Severe Crohn's Disease
The purpose of this study is to characterize the safety, efficacy and dose response of
BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an
insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor
(anti-TNF) therapy.
BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an
insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor
(anti-TNF) therapy.
Inclusion Criteria:
- Confirmed Crohn's Disease diagnosis via radiology, endoscopy or histology within prior
12 months. Diagnosed for at least 3 months
- Active Disease with Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450
- Failed conventional therapy or steroid dependent
Exclusion Criteria:
- Diagnosed/clinical findings of Ulcerative Colitis (UC), indeterminate colitis, non
colonic/ileal disease
- Stricture/stenosis, Stoma, proctocolectomy, subtotal colectomy, ileorectal anastomosis
- History of diverticulitis, or evidence of Gastrointestinal (GI) perforations
We found this trial at
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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University of Louisville The University of Louisville is a state supported research university located in...
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Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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