Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease
NCT01545050 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2021-12-03
Summary
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.
Conditions
Interventions
- BIOLOGICAL
-
Placebo matching with BMS-945429
Injection, Intravenous (IV), 0 mg, Day One Only, One Day
- BIOLOGICAL
-
Placebo matching with BMS-945429
Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, 8 weeks
- BIOLOGICAL
-
Placebo matching with BMS-945429
Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day
- BIOLOGICAL
-
Placebo matching with BMS-945429
Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, Up to 48 weeks
- BIOLOGICAL
-
BMS-945429
Injection, Intravenous (IV), 600 mg, Day One Only, One Day
- BIOLOGICAL
-
BMS-945429
Injection, Subcutaneous (SC), 200 mg, Week 8 only, One Day
- BIOLOGICAL
-
BMS-945429
Injection, Intravenous (IV), 300 mg, Day One Only, One Day
- BIOLOGICAL
-
BMS-945429
Injection, Subcutaneous (SC), 100 mg, Week 8 Only, One Day
- BIOLOGICAL
-
BMS-945429
Injection, Subcutaneous (SC), 400 mg, Day One and Week 4, 4 weeks
- BIOLOGICAL
-
BMS-945429
Injection, Intravenous (IV), 150 mg, Day One Only, One Day
- BIOLOGICAL
-
BMS-945429
Injection, Subcutaneous (SC), 100 mg, Every 4 weeks, Up to 48 weeks
- BIOLOGICAL
-
BMS-945429
Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 48 weeks
- BIOLOGICAL
-
BMS-945429
Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 96 weeks, depending on when subject enters this period
Sponsors & Collaborators
-
CSL Behring
lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-06-30
- Primary Completion
- 2013-12-31
- Completion
- 2013-12-31
Countries
- United States
- Austria
- Canada
- Czechia
- France
- Germany
- Hong Kong
- Hungary
- India
- Israel
- Italy
- Mexico
- Netherlands
- Poland
- South Korea
- Switzerland
- Taiwan
- United Kingdom
Study Locations
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