Clinical trial NCT05556265: A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study to Evaluate Clinical Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants With Alopecia Areata
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alopecia Areata
Keywords: Deucravacitinib
IM011134
BMS-986165
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-09-27
Enrollment: 94
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 evaluate the efficacy of deucravacitinib versus placebo at Week 24 and safety and tolerability of deucravacitinib versus placebo in adults with alopecia areata.


Eligibility criteria: Inclusion Criteria:

* Documented clinical diagnosis of alopecia areata (AA) for at least 6 months.
* Current episode of scalp hair loss (at screening) must meet the following criteria: duration at least 6 months; duration of current hair loss episode of AA affecting ≥ 50% of the scalp not exceeding 8 years; scalp hair loss has been stable (no significant spontaneous regrowth \[\> 10%\] over the last 6 months)
* SALT score ≥ 50 at Screening and Day 1. Participant with complete scalp hair loss (SALT score of 100) with or without body hair involvement can be included.

Exclusion Criteria:

* Participant with diffuse-type AA or other forms of hair loss, including traction alopecia, lichen planopilaris, central centrifugal cicatricial alopecia, frontal fibrosing alopecia, etc.
* Other active skin diseases affecting the scalp that in the opinion of the investigator may interfere with accurate assessment of SALT score.
* Extensive tattooing of the scalp that, in the opinion of the investigator, may interfere with the accurate assessment of SALT score.

Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Change From Baseline in Severity of Alopecia Tool Score at Week 24 in Placebo-Controlled Treatment Period
timeFrame: Baseline (Day 1) and Week 24
measure: Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period
timeFrame: From first dose (Day 1) and up to 30 days after last dose for all participants (up to approximately 28 weeks)
measure: Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period
timeFrame: From first dose (Day 1) of Week 25 and up to 30 days after last dose for all participants (up to approximately 28 weeks)
measure: Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
timeFrame: From first dose (Day 1) through Week 24
measure: Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
timeFrame: From Week 25 to Week 52
measure: Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period
timeFrame: First dose (Day 1) to Week 24
measure: Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period
timeFrame: Week 25 to Week 52
measure: Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period
timeFrame: First dose (Day 1) to Week 24
measure: Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period
timeFrame: Week 25 to Week 52
measure: Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period
timeFrame: First dose (Day 1) to Week 24
measure: Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters
timeFrame: Week 25 to Week 52
Secondary outcomes:
measure: Percentage of Participants Achieving a ≥ 50% Reduction in Severity of Alopecia Tool (SALT) Score (SALT50 Response) From Baseline at Week 24
timeFrame: Baseline (Day 1) and Week 24
measure: Percentage of Participants Achieving a Severity of Alopecia Tool (SALT) Score ≤20 at Week 24
timeFrame: Baseline (Day 1) and Week 24
measure: Percentage of Participants Achieving an Alopecia Areata Investigator Global Assessment (AA-IGA) Score of 0 or 1 at Week 24 With at Least a 2-Point Change From Baseline
timeFrame: Baseline (Day 1) and week 24
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Local Institution - 0016
state: California
city: New Haven
country: United States
facility: Local Institution - 0036
state: Connecticut
city: Tampa
country: United States
facility: Local Institution - 0018
state: Florida
city: Clinton Township
country: United States
facility: Local Institution - 0023
state: Michigan
city: New York
country: United States
facility: Local Institution - 0024
state: New York
city: Chapel Hill
country: United States
facility: Local Institution - 0019
state: North Carolina
city: Portland
country: United States
facility: Local Institution - 0011
state: Oregon
city: Pittsburgh
country: United States
facility: Local Institution - 0032
state: Pennsylvania
city: Austin
country: United States
facility: Local Institution - 0012
state: Texas
city: Houston
country: United States
facility: Local Institution - 0013
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0014
state: Texas
city: South Jordan
country: United States
facility: Local Institution - 0017
state: Utah
city: Kogarah
country: Australia
facility: Local Institution - 0003
state: New South Wales
city: Carlton
country: Australia
facility: Local Institution - 0005
state: Victoria
city: Winnipeg
country: Canada
facility: Local Institution - 0015
state: Manitoba
city: Markham
country: Canada
facility: Local Institution - 0021
state: Ontario
city: Peterborough
country: Canada
facility: Local Institution - 0009
state: Ontario
city: Richmond Hill
country: Canada
facility: Local Institution - 0010
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0034
state: Quebec
city: Québec
country: Canada
facility: Local Institution - 0027
state: Quebec
city: Nice
country: France
facility: Local Institution - 0033
city: Paris
country: France
facility: Local Institution - 0020
city: Hamamatsu-Shi
country: Japan
facility: Local Institution - 0031
city: Koto-Ku
country: Japan
facility: Local Institution - 0028
city: Mitaka-Shi
country: Japan
facility: Local Institution - 0030
city: Shinjuku-Ku
country: Japan
facility: Local Institution - 0029
city: Wroclaw
country: Poland
facility: Local Institution - 0026
state: DS
city: Warsaw
country: Poland
facility: Local Institution - 0025
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: