A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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

ClinicalTrials.gov ID

NCT05556265

Acronym / sponsor ID

IM011-134

Conditions

Alopecia Areata

Keywords

Deucravacitinib, IM011134, BMS-986165

Phase

Phase 2

Study type

Interventional

Recruitment status

TerminatedReason stopped: Business objectives have changed

Enrolment

94 participants (actual)

Lead sponsor

Bristol-Myers SquibbIndustry (pharma, biotech, devices)

Study start

8 Nov 2022 (actual)

Primary completion

6 Jan 2024 (actual)

Study completion

16 May 2024 (actual)

First posted

27 Sep 2022 (actual)

Results

Posted 28 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Double blind (participant, care provider)

Number of arms

3

Who may qualify

Ages

18 to 65 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Change From Baseline in Severity of Alopecia Tool Score at Week 24 in Placebo-Controlled Treatment Period

   Time frame: Baseline (Day 1) and Week 24

   The Severity of Alopecia Tool (SALT) score is a quantitative rating scale for measuring the severity of alopecia areata based on the amount of terminal hair loss in each of the 4 quadrants of the scalp: back region, top region, left and right regions of the scalp. To calculate a SALT score, the degree of scalp hair loss, as a percentage of each scalp region affected, is determined. Each region is multiplied by it's respective weighting factor (percentage surface area of the scalp in that area; back region [24%], top region [40%], left region [18%] and, right region [18%]), in order to achieve a subtotal for each region. The SALT score is the sum of the scalp hair loss in each area (sum of the subtotals). The score ranges from 0 to 100, the higher score reflects high severity of alopecia areata.

2. Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period

   Time frame: From first dose (Day 1) and up to 30 days after last dose for all participants (up to approximately 28 weeks)

   An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (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. Adverse event of interest included herpes zoster, malignancy, opportunistic infection or tuberculosis infection.

3. Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period

   Time frame: From first dose (Day 1) of Week 25 and up to 30 days after last dose for all participants (up to approximately 28 weeks)

   An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (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. Adverse event of interest included Herpes zoster, malignancy, opportunities infection or tuberculosis infection.

4. 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

   Time frame: From first dose (Day 1) through Week 24

   Blood samples were collected for assessment of laboratory test results. All abnormalities were graded as per CTCAE v5.0 on a scale from 1 to 4, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.

5. 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

   Time frame: From Week 25 to Week 52

   Blood samples were collected for assessment of laboratory test results. All abnormalities are graded as per CTCAE v5.0 on a scale from 1 to 4, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.

6. Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period

   Time frame: First dose (Day 1) to Week 24

   A 12-lead ECG was performed after the participant remained supine for at least 5 minutes prior to the ECG. The ECG results read by the principal study investigator or a qualified and delegated designee as per local requirements

7. Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period

   Time frame: Week 25 to Week 52

   A 12-lead ECG should be performed after the participant has remained supine for at least 5 minutes prior to the ECG. The ECG results will be read by the principal study investigator or a qualified and delegated designee as per local requirements

8. Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period

   Time frame: First dose (Day 1) to Week 24

   Vital signs such as systolic blood pressures (SBP), diastolic blood pressure (DBP) and heart rate were assessed. The evaluation of the marked abnormality criteria is based on participants highest change from baseline in the period. Blood pressure and heart rate were to be measured after the participant has been resting quietly for at least 5 minutes.

9. Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period

   Time frame: Week 25 to Week 52

   Vital signs such as systolic blood pressures (SBP), diastolic blood pressure (DBP) and heart rate were assessed. The evaluation of the marked abnormality criteria is based on participants highest change from baseline in the period. Blood pressure and heart rate were to be measured after the participant had been resting quietly for at least 5 minutes.

10. Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period

    Time frame: First dose (Day 1) to Week 24

    Participants were assessed for abnormalities in targeted physical parameters.

11. Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters

    Time frame: Week 25 to Week 52

    Participants were assessed for abnormalities in targeted physical parameters.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• BMS Clinical Trial InformationLink provided by the sponsor.
• FDA Safety Alerts and RecallsLink provided by the sponsor.
• BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
• Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

28 sites in 6 countries: see every site and its status.