A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Ulcerative Colitis (UC)
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Colitis, Ulcerative
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 305
- Locations
- 24
- Primary Endpoint
- Proportion of the subjects with clinical remission (defined as Mayo score ≤ 2 points with no individual subscore > 1 point) of BMS-936557 with that of the placebo
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of moderate to severe UC confirmed by endoscopic and histologic evidence
- •Mayo score ≥6 with an endoscopic subscore of ≥2
- •Inadequate response and/or intolerance to one or more conventional therapy (i.e. oral aminosalicylates, immunosuppressants, corticosteroids, and/or TNF antagonist)
Exclusion Criteria
- •Diagnosis of Crohn's Disease or Indeterminate Colitis
- •Diagnosis of UC that is limited to the rectum
- •Evidence of fulminant colitis, toxic megacolon, or bowel perforation
- •Current need for a colostomy or ileostomy
- •Previous total or subtotal colectomy
Arms & Interventions
Cohort 1: Induction
Placebo or Anti-IP-10 Antibody
Intervention: Placebo
Cohort 1: Induction
Placebo or Anti-IP-10 Antibody
Intervention: Anti-IP-10 Antibody
Cohort 2: Induction
Placebo or Anti-IP-10 Antibody
Intervention: Placebo
Cohort 2: Induction
Placebo or Anti-IP-10 Antibody
Intervention: Anti-IP-10 Antibody
Cohort 3: Induction
Placebo or Anti-IP-10 Antibody
Intervention: Placebo
Cohort 3: Induction
Placebo or Anti-IP-10 Antibody
Intervention: Anti-IP-10 Antibody
Maintenance
Placebo or Anti-IP-10 Antibody
Intervention: Placebo
Maintenance
Placebo or Anti-IP-10 Antibody
Intervention: Anti-IP-10 Antibody
Open Label
Intervention: Anti-IP-10 Antibody
Outcomes
Primary Outcomes
Proportion of the subjects with clinical remission (defined as Mayo score ≤ 2 points with no individual subscore > 1 point) of BMS-936557 with that of the placebo
Time Frame: End of Induction [Week 11, Induction Period-78 (IP-78)]
Secondary Outcomes
- Proportion of subjects with mucosal healing (defined as endoscopy subscore of ≤1 point) of BMS-936557 with that of the placebo(IP-78 (Week 11))
- Mean change from baseline at Inflammatory Bowel Disease Questionnaire (IBDQ) of subjects treated with BMS-936557 and placebo(Baseline (IP-1, Week 1) and IP-78 (Week 11))
- Proportion of the subjects with clinical response of BMS-936557 with that of the placebo(IP-78 (Week 11))
- Proportion of subjects reporting Adverse event (AE), Serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values(IP-78 (Week 11))