A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis
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| ClinicalTrials.gov Identifier: NCT04613518 |
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Recruitment Status :
Recruiting
First Posted : November 3, 2020
Last Update Posted : June 22, 2022
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Brief Summary:
The purpose of this study is to assess the safety and tolerability, efficacy, and biomarker response of BMS-986165 administered orally in participants with moderate to severe ulcerative colitis. The study was originally designed to test deucravacitinib at two doses for 12 weeks compared to placebo. After the initial 12-Week period, all subjects receive active therapy (open-label extension). With protocol amendment 2, one of the dose treatment arms is being removed from the 12-week double blind period with no change to the open-label extension.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colitis, Ulcerative | Drug: BMS-986165 Other: Placebo Comparator | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 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, Efficacy, and Biomarker Response of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis |
| Actual Study Start Date : | March 15, 2021 |
| Estimated Primary Completion Date : | February 22, 2023 |
| Estimated Study Completion Date : | December 27, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ulcerative colitis
MedlinePlus related topics:
Ulcerative Colitis
| Arm | Intervention/treatment |
|---|---|
| Experimental: BMS-986165 |
Drug: BMS-986165
Specified Dose on Specified Days |
| Placebo Comparator: Placebo |
Other: Placebo Comparator
Specified Dose on Specified Days |
| Experimental: Open label Extension, BMS-986165 |
Drug: BMS-986165
Specified Dose on Specified Days |
Primary Outcome Measures :
- Proportion of participants in clinical response [ Time Frame: At Week 12 ]
Secondary Outcome Measures :
- Number of adverse events (AEs) [ Time Frame: Baseline to Week 56 ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Confirmed diagnosis of ulcerative colitis (UC) at least 3 months' duration prior to screening
- Moderately to severely active UC as assessed by the modified Mayo score
- Documentation of an inadequate response, loss of response, or intolerance to a treatment course of 1 or more of the following standard of care medications: oral 5-aminosalicylic acids, corticosteroids, immunomodulators, anti-tumor necrosis factor (TNF) agents, integrin inhibitors[SA1]
- Documentation of prior treatment with corticosteroids for ≥ 4 weeks
- Males and females must agree to follow specific methods of contraception, if applicable
Exclusion Criteria:
- Current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC), ischemic colitis, or pseudomembranous colitis
- Current evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation
- History or evidence of any extensive colonic resection, or subtotal or total colectomy
- Women who are pregnant or breastfeeding
- Prior exposure to BMS-986165 or a tyrosine kinase 2 (TYK2) inhibitor
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): NCT04613518
Contacts
| Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com | 855-907-3286 | Clinical.Trials@bms.com | |
| Contact: First line of the email MUST contain NCT # and Site #. |
Locations
Show 24 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT04613518 |
| Other Study ID Numbers: |
IM011-127 2019-004878-26 ( EudraCT Number ) U1111-1245-2970 ( Other Identifier: World Health Organization ) |
| First Posted: | November 3, 2020 Key Record Dates |
| Last Update Posted: | June 22, 2022 |
| Last Verified: | June 2022 |
| 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 |