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
18 Years
N/A
Both
Crohn's Disease
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Proportion of subjects with clinical remission as measured by the Crohn's Disease Activity Index
Outcome Time Frame:
At 8 weeks during the Induction Period
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
IM133-005
NCT ID:
NCT01545050
Start Date:
June 2012
Completion Date:
September 2017
Related Keywords:
- Crohn's Disease
- Crohn Disease
Name | Location |
|---|---|
| Duke University Medical Center | Durham, North Carolina 27710 |
| University of Florida | Gainesville, Florida 32610-0277 |
| University of Louisville | Louisville, Kentucky 40202 |
| Local Institution | Vancouver, Washington |
| University of California, San Diego | La Jolla, California 92037-1709 |
| Local Institution | Wilmington, North Carolina |
| Local Institution | Chattanooga, Tennessee |
| Options Health Research, Llc | Tulsa, Oklahoma 74104 |
| Gastro One | Germantown, Tennessee 38138 |
| Precision Research Institute, LLC | San Diego, California 92114 |
| Premier Medical Group of the Hudson Valley, PC | Poughkeepsie, New York 12601 |
| South Denver Gastroenterology, Pc | Lone Tree, Colorado 80124 |
| Djl Research, Pllc | Charlotte, North Carolina 28210 |
| Gastrointestinal Research Institute | Newton, Pennsylvania 18940 |
