PsoriasisPhase 4NCT05478499

Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis

A Phase 4 study testing Deucravacitinib in people with Psoriasis, run by Bristol-Myers Squibb at 29 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare the efficacy and safety of deucravacitinib to placebo in participants with moderate-to-severe scalp psoriasis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis
What is being tested?: Deucravacitinib
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 154 participants
Where: 29 sitesin 5 countries
Study dates: 6 Oct 2022to 17 Oct 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women diagnosed with stable plaque psoriasis with scalp involvement for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the Investigator
Deemed by the Investigator to be a candidate for phototherapy or systemic therapy
Moderate-to-severe scalp psoriasis as defined by scalp-specific Physician's Global Assessment (ss-PGA) ≥ 3; ≥ 20% scalp surface area (SSA); Psoriasis Scalp Severity Index (PSSI) ≥ 12 at the Screening visit and Day 1
≥ 3% of Body Surface Area (BSA) involvement at the Screening visit and Day 1
Evidence of plaque psoriasis in a non-scalp area
Failed to respond to, or intolerant of ≥ 1 topical therapy for scalp psoriasis

Who cannot join

Target Disease Exceptions:
Has nonplaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-induced psoriasis) at Screening or Day 1 Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

29 sites in 5 countries.

Country

City, postcode or hospital

29 sites in 5 countries

United States14 sites

Local Institution - 0008
Beverly, Massachusetts, 01915
Local Institution - 0047
Bloomfield Hills, Michigan, 48302
Local Institution - 0049
East Windsor, New Jersey, 08520
Local Institution - 0001
Hot Springs, Arkansas, 71913
Local Institution - 0033
Houston, Texas, 77004
Local Institution - 0007
Indianapolis, Indiana, 46256
Local Institution - 0051
Kew Gardens, New York, 11415
Local Institution - 0041
Louisville, Kentucky, 40217
Local Institution - 0002
New Brighton, Minnesota, 55432
Local Institution - 0006
Norfolk, Virginia, 23502
Local Institution - 0005
Pittsburgh, Pennsylvania, 15213
Local Institution - 0003
Portland, Oregon, 97201
Local Institution - 0022
Rockville, Maryland, 20850
Local Institution - 0004
San Antonio, Texas, 78229

Other trials in United States

Germany5 sites

Local Institution - 0013
Frankfurt am Main, Hesse, 60590
Local Institution - 0048
Hamburg, 20246
Local Institution - 0012
Lübeck, 23538
Local Institution - 0011
Mahlow, 15831
Local Institution - 0038
Witten, Deutschland, 58454

Other trials in Germany

Poland4 sites

Local Institution - 0026
Krakow, 30438
Local Institution - 0017
Lodz, 90-436
Local Institution - 0014
Rzeszów, 35-055
Local Institution - 0015
Wroclaw, 51-685

Other trials in Poland

France3 sites

Local Institution - 0019
Paris, 75010
Local Institution - 0040
Romans-sur-Isère, 26102
Local Institution - 0044
Rouen, 76031

Other trials in France

United Kingdom3 sites

Local Institution - 0031
London, Greater London, SE1 9RT
Local Institution - 0045
Salford, Greater Manchester, M6 8HD
Local Institution - 0039
Southampton, HAMPSHIRE, SO16 6DU

Other trials in United Kingdom

About this study

Official title: A Phase 3B/4, Multicenter, Randomized, Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Moderate-to-severe Scalp Psoriasis (PSORIATYK SCALP)

The purpose of this study is to compare the efficacy and safety of deucravacitinib to placebo in participants with moderate-to-severe scalp psoriasis.

Conditions: Psoriasis
Being tested: Deucravacitinib, Placebo
Keywords: Scalp Psoriasis, BMS-986165, Deucravacitinib, Psoriasis, Psoriasis Special Sites
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DeucravacitinibDrug
Also called BMS-986165
Specified dose on specified days
PlaceboOther
Specified dose on specified days

Study groups in NCT05478499
Study group	Role	What they receive
Deucravacitinib	Experimental	Not described Receives: Drug: Deucravacitinib
Placebo then Deucravacitinib	Placebo comparator	Not described Receives: Drug: Deucravacitinib; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16
ss-PGA 0/1 response as a percentage of participants with an ss-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. Scalp lesions are evaluated in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease.
Measured: Baseline and Week 16

Secondary outcomes (8)

Percentage of Participants With a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16
PSSI 90 response as a percentage of participants who achieve at least 90% improvement from baseline in the PSSI score at Week 16. PSSI assesses severity of scalp disease in participants with scalp involvement with a 5-point Likert-type scale on the clinical parameters of erythema, induration, and desquamation. The scores are summed and multiplied by an integer (0 to 6) that represents the area of affected scalp. The PSSI score ranges from 0 to 72 with higher scores indicating more severe symptoms.
Measured: Baseline and Week 16
Change From Baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16
Change from baseline in scalp-specific itch numerical rating scale (NRS) score at week 16. The scalp-specific itch NRS is an 11-point horizontal scale anchored at 0 and 10 with 0 representing "no scalp itch" and 10 representing "worst scalp itch imaginable.". Overall severity of a participant's itching from scalp psoriasis is indicated by selecting the number that best describes the worst level of scalp itching within the past 24 hours.
Measured: Baseline and Week 16
Percentage of Participants With a Static Physician Global Assessment Score of 0 or 1 (s-PGA 0/1) at Week 16
s-PGA 0/1 response as a percentage of participants with an s-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. The s-PGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The s-PGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4).
Measured: Baseline and Week 16
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
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 that does not necessarily have a causal relation with this treatment.
Measured: From week 0 through week 16
Number of Participants Experiencing Serious Treatment Emergent Adverse Events (TEAEs)
A 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.
Measured: From week 0 through week 16
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Laboratory test results summary of Worst toxicity grade in SI units for hematology and chemistry using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1= mild and asymptomatic; Grade 2= moderate requiring minimal, local or noninvasive intervention; Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= events are usually severe enough to require hospitalization.
Measured: Week 0 through Week 16
Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests
Number of participants with laboratory abnormalities in potential drug-induced liver injury tests.
ALT=alanine aminotransferase AST=aspartate aminotransferase ULN=upper limit of normal
Measured: Week 0 through Week 16
Number of Participants With Abnormalities in Vital Signs
Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure.
Measured: Week 0 through Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Oct 202217 Oct 2024

First posted28 Jul 2022
Study start6 Oct 2022
Primary completion11 Jan 2024
Study completion17 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PsoriasisStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05478499
Sponsor's protocol ID: IM011-220
Other IDs: 2022-000797-26, U1111-1274-7417
Status last verified: Sep 2025
First submitted: 27 Jul 2022
Last updated: 28 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3B/4, Multicenter, Randomized, Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Moderate-to-severe Scalp Psoriasis (PSORIATYK SCALP)
ClinicalTrials.gov ID: NCT05478499
Acronym / sponsor ID: IM011-220
Conditions: Psoriasis
Keywords: Scalp Psoriasis, BMS-986165, Deucravacitinib, Psoriasis, Psoriasis Special Sites
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 154 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 6 Oct 2022 (actual)
Primary completion: 11 Jan 2024 (actual)
Study completion: 17 Oct 2024 (actual)
First posted: 28 Jul 2022 (actual)
Results: Posted 13 Mar 2025

Clinical summary

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

The purpose of this study is to compare the efficacy and safety of deucravacitinib to placebo in participants with moderate-to-severe scalp psoriasis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Deucravacitinib	Experimental	Drug: Deucravacitinib
Placebo then Deucravacitinib	Placebo comparator	Drug: Deucravacitinib, Other: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Men and women diagnosed with stable plaque psoriasis with scalp involvement for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the Investigator
Deemed by the Investigator to be a candidate for phototherapy or systemic therapy
Moderate-to-severe scalp psoriasis as defined by scalp-specific Physician's Global Assessment (ss-PGA) ≥ 3; ≥ 20% scalp surface area (SSA); Psoriasis Scalp Severity Index (PSSI) ≥ 12 at the Screening visit and Day 1
≥ 3% of Body Surface Area (BSA) involvement at the Screening visit and Day 1
Evidence of plaque psoriasis in a non-scalp area

Key exclusion criteria (2 listed)

Target Disease Exceptions:

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

Interventions

Intervention	Type	Arms
DeucravacitinibAlso: BMS-986165Specified dose on specified days	Drug	Deucravacitinib, Placebo then Deucravacitinib
PlaceboSpecified dose on specified days	Other	Placebo then Deucravacitinib

Primary outcome

Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16
Time frame: Baseline and Week 16
ss-PGA 0/1 response as a percentage of participants with an ss-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. Scalp lesions are evaluated in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease.

8 secondary outcomes

Percentage of Participants With a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16
Time frame: Baseline and Week 16
Change From Baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16
Time frame: Baseline and Week 16
Percentage of Participants With a Static Physician Global Assessment Score of 0 or 1 (s-PGA 0/1) at Week 16
Time frame: Baseline and Week 16
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
Time frame: From week 0 through week 16
Number of Participants Experiencing Serious Treatment Emergent Adverse Events (TEAEs)
Time frame: From week 0 through week 16
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Time frame: Week 0 through Week 16
Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests
Time frame: Week 0 through Week 16
Number of Participants With Abnormalities in Vital Signs
Time frame: Week 0 through Week 16

Results and safety

Results posted to the registry on 13 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Deucravacitinib	103	94
Placebo	51	45

Primary outcome: Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16

Time frame: Baseline and Week 16. Number (95% Confidence Interval). Unit: Percentage of responders

Measure	Deucravacitinib n = 103	Placebo n = 51
Full Analysis Set	48.5 (38.6 to 58.6)	13.7 (5.7 to 26.3)
Patient sub-population (s-PGA ≥ 3)	50.0 (39.6 to 60.4)	12.8 (4.8 to 25.7)

Deucravacitinib vs Placebo: Odds Ratio (OR): 6.2 (95% CI 2.5 to 15.3), p <0.0001, Cochran-Mantel-Haenszel
Deucravacitinib vs Placebo: Odds Ratio (OR): 7.0 (95% CI 2.7 to 18.4), p <0.0001, Cochran-Mantel-Haenszel

Population analysed: All randomized participants

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Controlled - Deucravacitinib	1 of 103 (1%)	47 of 103 (45.6%)	0 of 103
Placebo Controlled - Placebo	1 of 51 (2%)	14 of 51 (27.5%)	0 of 51
Active Treatment - Deucravacitinib - Deucravacitinib	4 of 94 (4.3%)	42 of 94 (44.7%)	1 of 94
Active Treatment - Placebo - Deucravacitinib	0 of 45 (0%)	16 of 45 (35.6%)	0 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
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RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

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.

Bristol-Myers Squibb study chair

Bristol-Myers Squibb

29 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Deucravacitinib in people with Psoriasis, run by Bristol-Myers Squibb at 29 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Germany, Poland, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16 (time frame: Baseline and Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05478499.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.