A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Crohn's Disease
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Crohn's Disease
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 121
- Locations
- 12
- Primary Endpoint
- Clinical remission (CDAI score of <150)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
Anti-IP10: Anti Interferon-inducible ligand 10
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults subjects with confirmed Crohn's Disease (CD) for at least 3 months
- •Moderate to severely active CD as defined by Crohn's Disease Activity Index (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)
Exclusion Criteria
- •Ulcerative colitis (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
Arms & Interventions
Cohort 1: Induction
Placebo
Intervention: Placebo
Cohort 2: Induction
Anti-IP-10 Antibody
Intervention: BMS-936557 (Anti-IP-10 Antibody)
Cohort 3: Induction
Anti-IP-10 Antibody
Intervention: BMS-936557 (Anti-IP-10 Antibody)
Cohort 1: Maintenance
Placebo
Intervention: Placebo
Cohort 2: Maintenance
Anti-IP-10 Antibody
Intervention: BMS-936557 (Anti-IP-10 Antibody)
Cohort 3: Maintenance
Anti-IP-10 Antibody
Intervention: BMS-936557 (Anti-IP-10 Antibody)
Cohort 1: Open Label
Anti-IP-10 Antibody
Intervention: BMS-936557 (Anti-IP-10 Antibody)
Outcomes
Primary Outcomes
Clinical remission (CDAI score of <150)
Time Frame: Week 11
CDAI: Crohn's Disease Activity Index
Secondary Outcomes
- Proportion of subjects in clinical remission (defined by an absolute CDAI score < 150)(Week 7 and Week 11)
- Safety of BMS-936557 in the induction period defined by proportion of subjects reporting AE, SAEs, AEs leading to discontinuation, and markedly abnormal laboratory values(Week 11)
- Proportion of subjects in clinical response (defined as CDAI score reduction from Baseline of ≥ 100 points or an absolute CDAI score of < 150)(Week 7 and Week 11)
- Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)(Week 11)