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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 September 2015
• Main ID: NCT01466374
• Date of registration: 03/11/2011
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease
• Scientific title: 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
• Date of first enrolment: December 2011
• Target sample size: 121
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01466374
• 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

Belgium, France, Hungary, Israel, Poland, Puerto Rico, South Africa, United States

Contacts

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

Key inclusion & exclusion 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



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

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Placebo

Drug: BMS-936557 (Anti-IP-10 Antibody)

Primary Outcome(s)

Clinical remission (CDAI score of <150) [Time Frame: Week 11]

Secondary Outcome(s)

Proportion of subjects in clinical response (defined as CDAI score reduction from Baseline of = 100 points or an absolute CDAI score of < 150) [Time Frame: Week 7 and Week 11]

Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) [Time Frame: Week 11]

Proportion of subjects in clinical remission (defined by an absolute CDAI score < 150) [Time Frame: 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 [Time Frame: Week 11]

Secondary ID(s)

2011-002981-19

IM129-008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors