Clinical trial NCT04613518: A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colitis, Ulcerative
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-11-03
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants in Clinical Response at Week 12
timeFrame: At week 12
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: 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)
measure: Number of Participants Experiencing Serious Adverse Events (SAEs)
timeFrame: 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)
measure: Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
timeFrame: 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)
measure: Number of Participants Experiencing Adverse Events of Special Interest (AEIs)
timeFrame: From first dose to 52 weeks after first dose
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Local Institution - 0014
state: California
city: Arlington Heights
country: United States
facility: Local Institution - 0036
state: Illinois
city: Shreveport
country: United States
facility: Local Institution - 0016
state: Louisiana
city: New York
country: United States
facility: Local Institution - 0015
state: New York
city: Chapel Hill
country: United States
facility: Local Institution - 0026
state: North Carolina
city: Cleveland
country: United States
facility: Local Institution - 0013
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution - 0020
state: Oklahoma
city: Garland
country: United States
facility: Local Institution - 0032
state: Texas
city: Lubbock
country: United States
facility: Local Institution - 0039
state: Texas
city: Southlake
country: United States
facility: Local Institution - 0033
state: Texas
city: Sydney
country: Australia
facility: Local Institution - 0005
state: New South Wales
city: Camberwell
country: Australia
facility: Local Institution - 0002
state: Victoria
city: Edmonton
country: Canada
facility: Local Institution - 0007
state: Alberta
city: London
country: Canada
facility: Local Institution - 0025
state: Ontario
city: Vaughan
country: Canada
facility: Local Institution - 0008
state: Ontario
city: Berlin
country: Germany
facility: Local Institution - 0003
city: Dresden
country: Germany
facility: Local Institution - 0019
city: Kiel
country: Germany
facility: Local Institution - 0006
city: Amsterdam
country: Netherlands
facility: Local Institution - 0009
state: Noord-Holland
city: Warsaw
country: Poland
facility: Local Institution - 0031
state: Mazowieckie
city: Warszawa
country: Poland
facility: Local Institution - 0030
state: Mazowieckie
city: Bydgoszcz
country: Poland
facility: Local Institution - 0029
city: Bydgoszcz
country: Poland
facility: Local Institution - 0028
city: San Juan
country: Puerto Rico
facility: Local Institution - 0011
city: London
country: United Kingdom
facility: Local Institution - 0023
state: England
city: Cambridge
country: United Kingdom
facility: Local Institution - 0027
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: