NCT01545050

Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Crohn's Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-03-06
• Last updated: 2021-12-03
• Results posted: 2021-12-03

Locations

56 sites across 18 countries: United States, Austria, Canada, Czechia, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, South Korea, Switzerland, Taiwan, United Kingdom