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.

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

sites

University of Florida

Gainesville, Florida 32610

(352) 392-3261