An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 5 February 2024
• Main ID: NCT03599622
• Date of registration: 11/07/2018
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease
• Scientific title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Crohn's Disease
• Date of first enrolment: July 16, 2018
• Target sample size: 241
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT03599622
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Australia, Belgium, Brazil, Canada, China, Croatia, Czechia, Denmark, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Documented diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening,
including ileal, colonic, or ileo-colonic disease distribution

- Must have had an inadequate response, loss of response, or intolerance to 1 or more of
the standard treatments

- Must have active moderate to severe CD

- Men and women must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

- Severe or fulminant colitis that is likely to require surgery or hospitalization

- Presence of a diagnosis of alternative forms of colitis (infectious, inflammatory
including ulcerative colitis, malignant, toxic, indeterminate, etc.) other than
Crohn's Disease

- Previous exposure to BMS-986165 in any study

- Any major illness/condition or evidence of an unstable clinical condition (eg, renal,
hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic,
psychiatric, or local active infection/infectious illness) that, in the investigator's
judgment, will substantially increase the risk to the participant

Other protocol-defined inclusion/exclusion criteria apply



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Granulomatous Enteritis

Crohn's Enteritis

Granulomatous Colitis

Crohn's Disease

Intervention(s)

Drug: BMS-986165

Other: Placebo

Primary Outcome(s)

Proportion of participants achieving endoscopic response at Week 12 [Time Frame: Week 12]

Proportion of participants achieving clinical remission at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

Proportion of participants who achieve a clinical response at Week 12 [Time Frame: Week 12]

Change from baseline in SES-CD (Simple Endoscopic Score for Crohn's Disease) at Week 12 [Time Frame: Week 12]

Proportion of participants who achieve PRO2 [Participant reported outcome based on the stool frequency and abdominal pain components of the Crohn's Disease Activity Index (CDAI)] remission at Week 12 [Time Frame: Week 12]

Secondary ID(s)

2017-001976-48

IM011-023

Source(s) of Monetary Support

Please refer to primary and secondary sponsors