A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis

NCT04613518 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IM011-1272019-004878-26U1111-1245-2970
• Study Type: interventional
• Target: 38
• Locations: 8 countries
• Sites: 26

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.

Conditions

Colitis, Ulcerative

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants in Clinical Response at Week 12

  Clinical response is defined as achieving the following changes in the modified Mayo score (excludes the physicians' global assessment) * A decrease from baseline in the modified Mayo score of ≥ 2 points, and * A decrease from baseline in the modified Mayo score ≥ 30%, and * A decrease in rectal bleeding (RB) subscore of ≥ 1 point or absolute RB subscore ≤ 1 Note: The modified Mayo score calculated to determine eligibility will also be used as the baseline disease activity score. The modified Mayo score is a 9-point scale (a score of 5 to 9 points denotes moderate to severe disease). The modified Mayo score is a sum of the following 3 components: * Stool frequency (SF) subscore (0 to 3) * Rectal bleeding (RB) subscore (0 to 3) * Endoscopic (ES) subscore (0 to 3)

  At week 12

• Number of Participants Experiencing Adverse Events (AEs)

  An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period.

  From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)

• Number of Participants Experiencing Serious Adverse Events (SAEs)

  An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period.

  From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)

• Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation

  An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period.

  From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)

• Number of Participants Experiencing Adverse Events of Special Interest (AEIs)

  An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. AEs of special interest include: skin events, influenza, herpes viral infections, opportunistic infections, tuberculosis, cardiovascular events, malignancy, and COVID-19.

  From first dose to 52 weeks after first dose

Study Arms (3)

BMS-986165

EXPERIMENTAL

Drug: BMS-986165

Placebo

PLACEBO COMPARATOR

Other: Placebo Comparator

Open label Extension, BMS-986165

EXPERIMENTAL

Drug: BMS-986165

Interventions

BMS-986165 DRUG

Specified Dose on Specified Days

BMS-986165; Open label Extension, BMS-986165

Placebo Comparator OTHER

Specified Dose on Specified Days

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (26)

Local Institution - 0014

San Diego, California, 92123, United States

Location

Local Institution - 0036

Arlington Heights, Illinois, 60005, United States

Location

Local Institution - 0016

Shreveport, Louisiana, 71105, United States

Location

Local Institution - 0015

New York, New York, 10029, United States

Location

Local Institution - 0026

Chapel Hill, North Carolina, 27599-7080, United States

Location

Local Institution - 0013

Cleveland, Ohio, 44195, United States

Location

Local Institution - 0020

Oklahoma City, Oklahoma, 73112, United States

Location

Local Institution - 0032

Garland, Texas, 75044, United States

Location

Local Institution - 0039

Lubbock, Texas, 74910, United States

Location

Local Institution - 0033

Southlake, Texas, 76092, United States

Location

Local Institution - 0005

Sydney, New South Wales, 2010, Australia

Location

Local Institution - 0002

Camberwell, Victoria, 3142, Australia

Location

Local Institution - 0007

Edmonton, Alberta, T6K4B2, Canada

Location

Local Institution - 0025

London, Ontario, N6A 5A5, Canada

Location

Local Institution - 0008

Vaughan, Ontario, L4L 4Y7, Canada

Location

Local Institution - 0003

Berlin, 12200, Germany

Location

Local Institution - 0019

Dresden, 01307, Germany

Location

Local Institution - 0006

Kiel, 24105, Germany

Location

Local Institution - 0009

Amsterdam, North Holland, 1081 HZ, Netherlands

Location

Local Institution - 0031

Warsaw, Masovian Voivodeship, 02-798, Poland

Location

Local Institution - 0030

Warsaw, Masovian Voivodeship, 04-501, Poland

Location

Local Institution - 0029

Bydgoszcz, 85-231, Poland

Location

Local Institution - 0028

Bydgoszcz, 85-794, Poland

Location

Local Institution - 0011

San Juan, 00935, Puerto Rico

Location

Local Institution - 0023

London, England, E11 1NR, United Kingdom

Location

Local Institution - 0027

Cambridge, CB2 0QQ, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 3, 2020
• Study Start: March 15, 2021
• Primary Completion: May 31, 2023
• Study Completion: November 29, 2023
• Last Updated: July 12, 2024
• Results First Posted: July 12, 2024

Record last verified: 2024-07

Locations

CA (3); GB (2); DE (3); US (10); PL (4); AU (2); NL (1); PR (1)