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

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ClinicalTrials.gov Identifier: NCT03599622
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Granulomatous Colitis Crohn's Disease Crohn's Enteritis Granulomatous Enteritis Drug: BMS-986165 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : May 9, 2022
Estimated Study Completion Date : March 12, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: BMS-986165 Dose 1 Drug: BMS-986165
Specified dose on specified days

Experimental: BMS-986165 Dose 2 Drug: BMS-986165
Specified dose on specified days

Placebo Comparator: Placebo Other: Placebo
Specified dose on specified days




Primary Outcome Measures :
  1. Proportion of participants achieving clinical remission at Week 12 [ Time Frame: Week 12 ]
    Clinical remission defined by Crohn's Disease Activity Index (CDAI)

  2. Proportion of participants achieving endoscopic response at Week 12 [ Time Frame: Week 12 ]
    Endoscopic response defined by Simple Endoscopic Score for Crohn's Disease (SES-CD)


Secondary Outcome Measures :
  1. Proportion of participants who achieve a clinical response at Week 12 [ Time Frame: Week 12 ]
  2. 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 ]
  3. Change from baseline in SES-CD (Simple Endoscopic Score for Crohn's Disease) at Week 12 [ Time Frame: Week 12 ]
  4. Proportion of participants achieving endoscopic normalization at Week 12 [ Time Frame: Week 12 ]
  5. Proportion of participants achieving endoscopic remission at Week 12 [ Time Frame: Week 12 ]
  6. Proportion of participants achieving deep remission at Week 12 [ Time Frame: Week 12 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Documented diagnosis of Crohn's Disease (CD) of at least 3 months' duration, including ileal, colonic, or ileo-colonic disease distribution
  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599622


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
Show Show 336 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03599622    
Other Study ID Numbers: IM011-023
2017-001976-48 ( EudraCT Number )
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
BMS-986165
Enteritis
Gastroenteritis
Dermatologic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action