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

Phase 2

Terminated

• Conditions: Granulomatous Colitis; Crohn's Enteritis; Crohn's Disease; Granulomatous Enteritis
• Interventions: Drug: BMS-986165; Other: Placebo

• Registration Number: NCT03599622
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to assess the safety and effectiveness of BMS-986165 compared to placebo in participants with moderately to severely active Crohn's Disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-11
• Study Start: 2018-07-16
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-26
• Primary Completion: 2022-12-12
• Disposition First Submitted: 2023-09-08
• Study Completion: 2023-10-23
• Results First Submitted: 2024-05-30
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Results First Posted: 2024-07-03
• Disposition First Posted: 2024-07-03
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 239

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMS-986165 Dose 1	BMS-986165	-
Placebo	Placebo	-
BMS-986165 Dose 2	BMS-986165	-

Primary Outcome Measures

Name	Time	Method
Percent of Participants Achieving Clinical Remission at Week 12	12 weeks after first dose	Percent of participants achieving clinical remission at Week 12. Clinical remission is defined as achieving a Crohn's Disease Activity Index (CDAI) Score below 150. CDAI is a tool that helps doctors measure how severe someone's Crohn's disease is. It uses questions about symptoms experienced over a week to calculate a score. The scores range from 0 to 600 and are classified into different categories. Scores from 0 to 149 suggest the disease may be in remission. Scores from 150 to 220 indicate mild activity. Scores from 220 to 450 mean the disease is moderate to severe. Scores from 451 to 600 indicate severe disease. Higher scores mean more severe symptoms.; Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.
Percent of Participants Achieving Endoscopic Response at Week 12	12 weeks after first dose	Endoscopic Response is defined as \>= 50% decrease from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel and checks for things like ulcers and inflammation. Each part is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. Baseline refers to the initial set of before data collected from participants before starting study treatment.; Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.

Secondary Outcome Measures

Name	Time	Method
Percent of Participants Achieving Clinical Response at Week 12	12 weeks after first dose	Clinical response is defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of ≥ 100 points or a total CDAI score \< 150. CDAI is a tool that helps doctors measure how severe someone's Crohn's disease is. It uses questions about symptoms experienced over a week to calculate a score. The scores range from 0 to 600 and are classified into different categories. Scores from 0 to 149 suggest the disease may be in remission. Scores from 150 to 220 indicate mild activity. Scores from 220 to 450 mean the disease is moderate to severe. Scores from 451 to 600 indicate severe disease. Higher scores mean more severe symptoms. Baseline refers to the initial set of before data collected from participants before starting study treatment.; Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.
Percent of Participants Who Achieving Patient Reported Outcomes 2 (PRO2) Remission at Week 12	12 weeks after first dose	The Patient Reported Outcomes 2 (PRO2) is a way for patients to report how they're feeling. It focuses on two things: how often they have loose or liquid stools, and how much abdominal pain they have. They keep track of these things every day for a week. Stool frequency is rated on a scale from 0 to 3, with 0 being the normal number of stools per day to 3 which is \>/=5 stools more than normal per day. The pain is rated on a scale from 0 to 3, with 0 being no pain and 3 being severe pain. The scores for these two things are added up to get a total score ranging from 0-6. If the average daily score for abdominal pain is 1 or less, and the average number of loose or liquid stools is 3 or less, then the disease might be in remission.; Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.
Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12	12 weeks after first dose	The SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel and checks for ulcer size, ulcerated surface, inflamed surface, and stenosis. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. Baseline refers to the initial set of before data collected from participants starting study treatment.

Trial Locations

Locations (257)

Local Institution - 0258; 🇺🇸 Los Angeles, California, United States

Local Institution - 0247; 🇺🇸 Aurora, Colorado, United States

Local Institution - 0001; 🇺🇸 Hamden, Connecticut, United States

Local Institution - 0255; 🇺🇸 Clearwater, Florida, United States

Local Institution - 0259; 🇺🇸 Jacksonville, Florida, United States

Local Institution - 0261; 🇺🇸 Jacksonville, Florida, United States

Local Institution - 0276; 🇺🇸 Largo, Florida, United States

Local Institution - 0232; 🇺🇸 Miami, Florida, United States

Local Institution - 0162; 🇺🇸 New Port Richey, Florida, United States

Local Institution - 0201; 🇺🇸 Orlando, Florida, United States

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