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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05556265




Registration number
NCT05556265
Ethics application status
Date submitted
23/09/2022
Date registered
27/09/2022

Titles & IDs
Public title
A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata
Scientific 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
Secondary ID [1] 0 0
U1111-1246-1767
Secondary ID [2] 0 0
IM011-134
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alopecia Areata 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Deucravacitinib
Other interventions - Placebo

Experimental: Deucravacitinib Dose 1 -

Experimental: Deucravacitinib Dose 2 -

Placebo comparator: Placebo, followed by Deucravacitinib Dose 1 or Dose 2. -


Treatment: Drugs: Deucravacitinib
Specified dose on specified days

Other interventions: Placebo
Placebo was administered.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Severity of Alopecia Tool Score at Week 24 in Placebo-Controlled Treatment Period
Timepoint [1] 0 0
Baseline (Day 1) and Week 24
Primary outcome [2] 0 0
Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period
Timepoint [2] 0 0
From first dose (Day 1) and up to 30 days after last dose for all participants (up to approximately 28 weeks)
Primary outcome [3] 0 0
Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period
Timepoint [3] 0 0
From first dose (Day 1) of Week 25 and up to 30 days after last dose for all participants (up to approximately 28 weeks)
Primary outcome [4] 0 0
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
Timepoint [4] 0 0
From first dose (Day 1) through Week 24
Primary outcome [5] 0 0
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
Timepoint [5] 0 0
From Week 25 to Week 52
Primary outcome [6] 0 0
Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period
Timepoint [6] 0 0
First dose (Day 1) to Week 24
Primary outcome [7] 0 0
Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period
Timepoint [7] 0 0
Week 25 to Week 52
Primary outcome [8] 0 0
Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period
Timepoint [8] 0 0
First dose (Day 1) to Week 24
Primary outcome [9] 0 0
Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period
Timepoint [9] 0 0
Week 25 to Week 52
Primary outcome [10] 0 0
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period
Timepoint [10] 0 0
First dose (Day 1) to Week 24
Primary outcome [11] 0 0
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters
Timepoint [11] 0 0
Week 25 to Week 52
Secondary outcome [1] 0 0
Percentage of Participants Achieving a = 50% Reduction in Severity of Alopecia Tool (SALT) Score (SALT50 Response) From Baseline at Week 24
Timepoint [1] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [2] 0 0
Percentage of Participants Achieving a Severity of Alopecia Tool (SALT) Score =20 at Week 24
Timepoint [2] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Baseline (Day 1) and week 24

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/05/2024
Sample size
Target
Accrual to date
Final
94
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Local Institution - 0003 - Kogarah
Recruitment hospital [2] 0 0
Local Institution - 0005 - Carlton
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
Canada
State/province [11] 0 0
Manitoba
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
France
State/province [14] 0 0
Nice
Country [15] 0 0
France
State/province [15] 0 0
Paris
Country [16] 0 0
Japan
State/province [16] 0 0
Hamamatsu-Shi
Country [17] 0 0
Japan
State/province [17] 0 0
Koto-Ku
Country [18] 0 0
Japan
State/province [18] 0 0
Mitaka-Shi
Country [19] 0 0
Japan
State/province [19] 0 0
Shinjuku-Ku
Country [20] 0 0
Poland
State/province [20] 0 0
DS
Country [21] 0 0
Poland
State/province [21] 0 0
Warsaw

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol Study Protocol and Statistical Analysis Plan
Statistical analysis plan Study Protocol and Statistical Analysis Plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05556265