Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT01294410
• Date of registration: 10/02/2011
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis
• Scientific title: 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)
• Date of first enrolment: March 2011
• Target sample size: 305
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01294410
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Australia, Austria, Belgium, Brazil, Canada, France, Germany, Hungary, Italy, Mexico, Netherlands, Poland, South Africa, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Drug: Placebo

Drug: Anti-IP-10 Antibody

Primary Outcome(s)

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 Outcome(s)

Proportion of the subjects with clinical response of BMS-936557 with that of the placebo [Time Frame: IP-78 (Week 11)]

Proportion of subjects with mucosal healing (defined as endoscopy subscore of =1 point) of BMS-936557 with that of the placebo [Time Frame: IP-78 (Week 11)]

Proportion of subjects reporting Adverse event (AE), Serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values [Time Frame: IP-78 (Week 11)]

Mean change from baseline at Inflammatory Bowel Disease Questionnaire (IBDQ) of subjects treated with BMS-936557 and placebo [Time Frame: Baseline (IP-1, Week 1) and IP-78 (Week 11)]

Secondary ID(s)

2010-022506-41

IM129-005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors