Induction and Maintenance Study of BMS-936557 in Patients with Moderate to Severely Active Crohn’s Disease

• Conditions: CROHN’S DISEASE; MedDRA version: 16.0Level: LLTClassification code 10058815Term: Crohn's disease acute episodeSystem Organ Class: 100000004856; MedDRA version: 16.0Level: LLTClassification code 10011402Term: Crohn's disease (colon)System Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-002981-19-BE
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-14
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

•Adults subjects with confirmed CD for at least 3 months.
•Moderate to severely active CD as defined by CDAI 220 to 450
•In the past have had insufficient response and or intolerance to = 1 of the conventional therapy (immunosuppressants, corticosteroids and/or approved biologic therapy)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 136
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

•UC or indeterminate colitis
•Short bowel syndrome
•Known stricture or noninflammatory stenosis leading to symptoms of obstruction
•Current stoma or current need for colostomy or ileostomy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn’s Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn’s Disease;Secondary Objective: 1.Proportion of subjects in clinical remission<br>2.Proportion of subjects in clinical response <br>3.Mean change from baseline in IBDQ<br>4.Safety of BMS-936557 in the induction period.<br>;Primary end point(s): Clinical remission at Week 11 (CDAI score of <150);Timepoint(s) of evaluation of this end point: Week 11

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Proportion of subjects in clinical remission<br>2.Proportion of subjects in clinical response <br>3.Mean change from baseline in IBDQ<br>4.Safety of BMS-936557 in the induction period;Timepoint(s) of evaluation of this end point: 1.Week 7 and Week 11<br>2.Week 7 and Week 11 <br>3.Week 11<br>4.Week 11