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

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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
9
sites
Germantown, Tennessee 38138
1600
mi
from 91732
Germantown, TN
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
2104
mi
from 91732
Gainesville, FL
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
95
mi
from 91732
La Jolla, CA
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Lone Tree, Colorado
817
mi
from 91732
Lone Tree, CO
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
1812
mi
from 91732
Louisville, KY
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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...
2433
mi
from 91732
Poughkeepsie, NY
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San Diego, California 92115
105
mi
from 91732
San Diego, CA
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Tulsa, Oklahoma 74137
1253
mi
from 91732
Tulsa, OK
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6093
mi
from 91732
Wien,
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