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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

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

Clinicaltrials.gov identifier NCT03934216

Recruitment Status Recruiting

First Posted May 1, 2019

Last update posted June 9, 2020

Study Description

Brief summary:

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

  • Condition or Disease:Ulcerative Colitis
  • Intervention/Treatment: Drug: BMS-986165
    Drug: Placebo
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: August 2021
  • Estimated Study Completion Date: August 2021
Arms and interventions
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
Outcome Measures
  • 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 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.

Contacts and Locations
Contacts

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 119 Study Locations
Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information
  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT03934216 History of Changes
  • Other Study ID Numbers: IM011-024, 2018-004694-27
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: June 9, 2020
  • Last Verified: June 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Colitis
    Colitis, Ulcerative
    Ulcer