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Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis (UC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03934216
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to assess the efficacy and safety of BMS-986165 in ulcerative colitis.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: BMS-986165 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 Ulcerative Colitis
Actual Study Start Date : May 3, 2019
Estimated Primary Completion Date : August 16, 2021
Estimated Study Completion Date : August 16, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BMS-986165
Specified Dose on Specified Days
Drug: BMS-986165
Specified Dose on Specified Days

Placebo Comparator: Placebo
Specified Dose on Specified Days
Drug: Placebo
Specified Dose on Specified Days




Primary Outcome Measures :
  1. Proportion of Participants Who Achieve Clinical Remission per Adapted Mayo Score [ Time Frame: At Week 12 ]
    Adapted Mayo score is defined as stool frequency subscore (SFS) to be less than or equal to (<=1), with greater than or equal to (>=) 1 point decrease from baseline and rectal bleeding subscore (RBS) of 0 and endoscopic subscore <=1.


Secondary Outcome Measures :
  1. Proportion of Participants Achieving Clinical Response per Adapted Mayo Score [ Time Frame: At Week 12 ]
    Clinical response per adapted Mayo is defined as a decrease from baseline in the adapted Mayo score >= 2 points and a decrease from baseline in the adapted mayo score >= 30 percent (%), and a decrease in RBS >= 1 or an absolute RBS <= 1.

  2. Proportion of Participants with Endoscopic Response [ Time Frame: At Week 12 ]
    Endoscopic response is defined as an endoscopic subscore <=1.

  3. Proportion of Participants with Endoscopic Remission [ Time Frame: At Week 12 ]
    Endoscopic remission is defined as an endoscopic subscore =0.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of UC at least 12 weeks prior to screening
  • Active UC with an an adapted Mayo score of 5 to 9 points, endoscopic subscore of >= 2
  • Demonstrated an inadequate response, loss of response, or intolerance to at lease one of the following treatments including, 5-aminosalicylic acids (ASAs), corticosteroids, immunosuppressants, anti-tumor necrosis factor (TNF)-α agents, integrin inhibitor

Exclusion Criteria:

  • Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC), ischemic colitis, pseudomembranous colitis
  • Current evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation
  • History or evidence of any extensive colonic resection, subtotal or total colectomy, with or without presence of a stoma or ileoanal pouch.

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): NCT03934216


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 119 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: NCT03934216    
Other Study ID Numbers: IM011-024
2018-004694-27 ( EudraCT Number )
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 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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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
BMS-986165
Dermatologic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action