NCT05556265 is a Phase 2 clinical trial of Deucravacitinib in Alopecia Areata, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT05556265?

NCT05556265 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT05556265?

Interventions in NCT05556265: Deucravacitinib, Placebo.

What condition does NCT05556265 study?

NCT05556265 studies Alopecia Areata.

Is NCT05556265 still recruiting?

NCT05556265 is currently terminated. Last updated 31 May 2025.

Are results published for NCT05556265?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-05-31 · How we verify

NCT05556265

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 2 Results posted Last updated 31 May 2025

What this trial tests

Phase 2 trial testing Deucravacitinib in Alopecia Areata in 94 participants. Terminated before completion.

Timeline

8 November 2022

Primary endpoint
6 January 2024

16 May 2024

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	94
Start date	8 November 2022
Primary completion	6 January 2024
Estimated completion	16 May 2024
Sites	28 locations across France, Japan, Poland, Canada, Australia, United States

Drugs / interventions tested

Deucravacitinib (DEUCRAVACITINIB) — full drug profile →
Placebo

Conditions studied

Alopecia Areata — all drugs for Alopecia Areata →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

Adults 18 to 65, any sex, with Alopecia Areata. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	-5.809	± 13.3892
Placebo-Controlled: Deucravacitinib 6 mg BID	1.027	± 14.7258
Placebo	-7.302	± 17.8732

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

Treatment Emergent Adverse Events

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	25
Placebo-Controlled: Deucravacitinib 6 mg BID	28
Placebo	20

Serious Treatment Emergent Adverse Events

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	1
Placebo-Controlled: Deucravacitinib 6 mg BID	1
Placebo	0

Treatment Emergent Adverse Events Leading to Discontinuation of Study

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	1
Placebo-Controlled: Deucravacitinib 6 mg BID	3
Placebo	0

TEAE of Interest-Herpes Zoster

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	1
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	0

TEAE of Interest-Malignancy-Bowen's Disease)

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	1
Placebo	0

TEAE of Interest-Malignancy-Nodular lymphocyte predominant Hodgkin Lymphoma

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	1
Placebo	0

TEAE of Interest - Opportunistic Infections

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	0

TEAE of Interest - Tuberculosis Infection

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	0

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

Treatment Emergent Adverse Events

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	21
Active Treatment Period: Deucravacitinib 6 mg BID	17
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	13
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	14

Serious Treatment Emergent Adverse Events

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	1
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

Treatment Emergent Adverse Events Leading to Discontinuation of Study

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	1
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	1
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

TEAE of Interest-Herpes Zoster

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

TEAE of Interest-Malignancy-Bowen's Disease

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

TEAE of Interest-Malignancy-Nodular lymphocyte predominant Hodgkin Lymphoma

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

TEAE of Interest - Opportunistic Infections

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

TEAE of Interest - Tuberculosis Infection

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	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 Primary · 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.

HEMOGLOBIN, LOW

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	0

PLATELET COUNT, LOW

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	0

LEUKOCYTES, LOW

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	0

ALANINE AMINOTRANSFERASE (ALT), HIGH

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	0

ALKALINE PHOSPHATASE (ALP), HIGH

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	0

ASPARTATE AMINOTRANSFERASE (AST), HIGH

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	0

BILIRUBIN, TOTAL, HIGH

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	0

CREATININE, ENZYMATIC, HIGH

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	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 Primary · 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.

HEMOGLOBIN, LOW

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

PLATELET COUNT, LOW

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

LEUKOCYTES, LOW

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

ALANINE AMINOTRANSFERASE (ALT), HIGH

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

ALKALINE PHOSPHATASE (ALP), HIGH

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

ASPARTATE AMINOTRANSFERASE (AST), HIGH

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

BILIRUBIN, TOTAL, HIGH

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

CREATININE, ENZYMATIC, HIGH

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period Primary · 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

QTCF 450 -< 480 MILLISECONDS (MSEC)

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	2
Placebo	1

QTCF 480 -< 500 MSEC

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	0

QTCF >= 500 MSEC

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	0

QTCF 30 < CHANGE FROM BASELINE <= 60 MSEC

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	1
Placebo	0

QTCF CHANGE FROM BASELINE > 60 MSEC

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	0

PR INTERVAL >= 200 MSEC

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	2
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	1

QRS INTERVAL >= 120 MSEC

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	1

Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period Primary · 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

QTCF 450 -< 480 MILLISECONDS (MSEC)

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

QTCF 480 -< 500 MSEC

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

QTCF >= 500 MSEC

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

QTCF 30 < CHANGE FROM BASELINE <= 60 MSEC

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	1
Active Treatment Period: Deucravacitinib 6 mg BID	1
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	1
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	1

QTCF CHANGE FROM BASELINE > 60 MSEC

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

PR INTERVAL >= 200 MSEC

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	1
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	1
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	1

QRS INTERVAL >= 120 MSEC

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	1
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	1
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

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

HEART RATE > 100 BPM AND CHANGE FROM BASELINE > 30 BPM

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	1
Placebo	0

HEART RATE < 55 BPM AND CHANGE FROM BASELINE < -15 BPM

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	1
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	0

SBP >140 MM HG AND CHANGE FROM BASELINE > 20 MM HG

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	1
Placebo-Controlled: Deucravacitinib 6 mg BID	4
Placebo	1

SBP <90 MM HG AND CHANGE FROM BASELINE < -20 MM HG

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	1

DBP >90 MM HG AND CHANGE FROM BASELINE > 10 MM HG

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	3
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	1

DBP <55 MM HG AND CHANGE FROM BASELINE < -10 MM HG

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	0
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	1

Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period Primary · Week 25 to Week 52

HEART RATE > 100 BPM AND CHANGE FROM BASELINE > 30 BPM

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	1

HEART RATE < 55 BPM AND CHANGE FROM BASELINE < -15 BPM

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	1
Active Treatment Period: Deucravacitinib 6 mg BID	1
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

SBP >140 MM HG AND CHANGE FROM BASELINE > 20 MM HG

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	1
Active Treatment Period: Deucravacitinib 6 mg BID	1
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	1

SBP <90 MM HG AND CHANGE FROM BASELINE < -20 MM HG

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

DBP >90 MM HG AND CHANGE FROM BASELINE > 10 MM HG

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	0
Active Treatment Period: Deucravacitinib 6 mg BID	1
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	3

DBP <55 MM HG AND CHANGE FROM BASELINE < -10 MM HG

Group	Value	95% CI
Active Treatment Period: Deucravacitinib 6 mg QD	1
Active Treatment Period: Deucravacitinib 6 mg BID	0
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD	1
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID	0

Percentage of Participants Achieving a ≥ 50% Reduction in Severity of Alopecia Tool (SALT) Score (SALT50 Response) From Baseline at Week 24 Secondary · 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 its respective weighting factor (percentage surface area of the scalp in that area; Back region \[24%\], Left Region \[18%\], Right Region \[18%\], Top Region \[40%\]), in order to achie

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	3.1
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	6.5

Percentage of Participants Achieving a Severity of Alopecia Tool (SALT) Score ≤20 at Week 24 Secondary · 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 its respective weighting factor (percentage surface area of the scalp in that area; Back region \[24%\], Left Region \[18%\], Right Region \[18%\], Top Region \[40%\]), in order to achie

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	3.1
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	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 Secondary · Baseline (Day 1) and week 24

The AA-IGA utilizes a 5-points scale, in which the investigator assesses scalp hair loss based on the SALT assessment. The AA-IGA measures alopecia areata severity at a single point in time(without taking into account the baseline disease condition).The participant's scalp hair loss, as it look at the time of evaluation is scored as none (0) (0% scalp hair loss), limited (1) (1%-20% scalp hair loss), moderate (2) (21%-49% scalp hair loss), severe (3) (50%-94% scalp hair loss), or very severe (4)(95%-100 % scalp hair loss).

Group	Value	95% CI
Placebo-Controlled: Deucravacitinib 6 mg QD	3.1
Placebo-Controlled: Deucravacitinib 6 mg BID	0
Placebo	0

Adverse events — posted to ClinicalTrials.gov

Time frame: All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo-Controlled: Deucravacitinib 6 mg QD

Serious: 1/32 (3%)

Deaths: 0/32

Placebo-Controlled: Deucravacitinib 6 mg BID

Serious: 1/31 (3%)

Deaths: 0/31

Placebo

Serious: 0/31 (0%)

Deaths: 0/31

Active-Treatment Period: Deucravacitinib 6 mg QD

Serious: 0/32 (0%)

Deaths: 0/32

Active-Treatment Period: Deucravacitinib 6 mg BID

Serious: 1/26 (4%)

Deaths: 0/26

Active-Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD

Serious: 0/16 (0%)

Deaths: 0/16

Active-Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID

Serious: 0/15 (0%)

Deaths: 0/15

Serious adverse events (3 terms)

Reaction	System	Placebo-Controlled: Deucra…	Placebo-Controlled: Deucra…	Placebo	Active-Treatment Period: D…	Active-Treatment Period: D…	Active-Treatment Period: P…	Active-Treatment Period: P…
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—
Ligament sprain	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Nodular lymphocyte predominant Hodgkin Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—

Other adverse events (44 terms — click to expand)

Reaction	System	Placebo-Controlled: Deucra…	Placebo-Controlled: Deucra…	Placebo	Active-Treatment Period: D…	Active-Treatment Period: D…	Active-Treatment Period: P…	Active-Treatment Period: P…
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—
Folliculitis	Infections and infestations	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—
Acne	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Aphthous ulcer	Gastrointestinal disorders	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—
Food poisoning	Gastrointestinal disorders	—	—	—	—	—	—	—
Mouth ulceration	Gastrointestinal disorders	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—
Oral herpes	Infections and infestations	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—
Tonsillitis	Infections and infestations	—	—	—	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—	—	—	—
Weight increased	Investigations	—	—	—	—	—	—	—
Hypercholesterolaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Rosacea	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Hypoacusis	Ear and labyrinth disorders	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—
Amalgam tattoo	Gastrointestinal disorders	—	—	—	—	—	—	—
Mass	General disorders	—	—	—	—	—	—	—
Seasonal allergy	Immune system disorders	—	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—	—
Conjunctivitis	Infections and infestations	—	—	—	—	—	—	—
Fungal infection	Infections and infestations	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—
Laryngitis	Infections and infestations	—	—	—	—	—	—	—
Nail infection	Infections and infestations	—	—	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—	—	—
Vulvovaginal candidiasis	Infections and infestations	—	—	—	—	—	—	—

Most-reported serious reactions: Viral upper respiratory tract infection, Ligament sprain, Nodular lymphocyte predominant Hodgkin Lymphoma.

Data from ClinicalTrials.gov NCT05556265 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

JAK/STAT pathway: Extracellular signals, diseases, immunity, and therapeutic regimens.
Hu Q, Bian Q, Rong D, Wang L, et al · · 2023 · cited 190× · PMID 36911202 · DOI 10.3389/fbioe.2023.1110765
Inhibition of T-cell activity in alopecia areata: recent developments and new directions.
Passeron T, King B, Seneschal J, Steinhoff M, et al · · 2023 · cited 54× · PMID 38022501 · DOI 10.3389/fimmu.2023.1243556
Tyk2 Targeting in Immune-Mediated Inflammatory Diseases.
Rusiñol L, Puig L. · · 2023 · cited 54× · PMID 36834806 · DOI 10.3390/ijms24043391
Allosteric TYK2 inhibition: redefining autoimmune disease therapy beyond JAK1-3 inhibitors.
Jensen LT, Attfield KE, Feldmann M, Fugger L. · · 2023 · cited 45× · PMID 37863021 · DOI 10.1016/j.ebiom.2023.104840
Deucravacitinib for the treatment of psoriatic arthritis: the evidence so far.
Martins A, Lé AM, Torres T. · · 2023 · cited 10× · PMID 37168876 · DOI 10.7573/dic.2023-2-7
Rapid hair regrowth in an alopecia universalis patient with deucravacitinib: A case report.
Oliel S, Moussa S, Stanciu M, Netchiporouk E. · · 2023 · cited 5× · PMID 38033914 · DOI 10.1177/2050313x231213135
Fine-tuning SLE treatment: the potential of selective TYK2 inhibition.
Satoh-Kanda Y, Nakayamada S, Tanaka Y. · · 2024 · cited 4× · PMID 39740929 · DOI 10.1136/rmdopen-2024-005072
Overview of alopecia areata for managed care and payer stakeholders in the United States.
King B, Pezalla E, Fung S, Tran H, et al · · 2023 · cited 3× · PMID 37219075 · DOI 10.18553/jmcp.2023.22371

Verify or expand the search:

Other trials of Deucravacitinib

Trials testing the same drug.

NCT07280702 — Deucravacitinib-TNFi Combination Therapy for Difficult-to-Control Psoriatic Disease · Phase 4 · not yet recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis · Phase 4 · not yet recruiting
NCT06979453 — A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants Wit · Phase 3 · recruiting
NCT07116967 — Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK) · Phase 3 · recruiting
NCT07256015 — Deucravacitinib for Patients With Moderate/Severe Psoriasis: A Real-Life Experience in Italy · recruiting

Other recruiting trials for Alopecia Areata

Currently open trials in the same condition.

NCT07242638 — Treatment of Atopic Dermatitis and Alopecia Areata With Abrocitinib in Individuals With Down Syndrome · Phase 2 · recruiting
NCT07311564 — A Study of LAD603 in Adults With Alopecia Areata · Phase 2 · recruiting
NCT07250997 — PALLAS Laser for Skin Diseases · NA · recruiting
NCT07205159 — A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata. · Phase 1 · recruiting
NCT06747611 — Evaluation of Microbiota Transplant Therapy in Patients With Alopecia Areata · Phase 2 · recruiting

Other Bristol-Myers Squibb trials

Trials by the same sponsor.

NCT07441408 — Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07459543 — A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unre · Phase 4 · not yet recruiting
NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder · Phase 3 · not yet recruiting
NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism · Phase 3 · not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05556265 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 31 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05556265.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing