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Palmoplantar PsoriasisPhase 4NCT06042920

A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis

A Phase 4 study testing Deucravacitinib in people with Palmoplantar Psoriasis and Genital Psoriasis, run by Bristol-Myers Squibb at 31 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to measure the safety and effectiveness of deucravatinib in participants with non-pustular palmoplantar psoriasis and genital psoriasis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Palmoplantar Psoriasis, Genital Psoriasis
What is being tested?
Deucravacitinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
130 participants
Where
31 sitesin 3 countries
Study dates
9 Oct 2023to 25 Apr 2025
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 involvement of the palm(s)and/or sole(s) for at least 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.
  • Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day 1.
  • Moderate-to-severe non-pustular PP psoriasis, defined as pp-PGA score of ≥ 3 on a 5-pointscale and pp-PASI ≥ 8 at both screening visit and Day 1.
  • A total maximum of 5 sterile pustules across both palms and soles limited only to psoriatic plaques will be allowed.
  • Evidence of typical plaque psoriasis outside palms and soles at both screening visit and Day 1.
  • Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
Show all 13Show fewer
  • Failed to respond to, or intolerant of ≥ 1 topical therapy.
  • Men and women diagnosed with stable plaque psoriasis with involvement of the genital area for at least 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.
  • Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day 1.
  • Moderate-to-severe GenPs, defined as static Physician's Global Assessment of Genitalia (s-PGA-G) score of ≥ 3 on a 6-point scale at both screening visit and Day 1.
  • Evidence of typical plaque psoriasis in a non-genital area at both screening visit and Day 1.
  • Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
  • Failed to respond to, or intolerant of ≥ 1 topical therapy.

Who cannot join

  • Target Disease Exceptions
  • Has non-plaque psoriasis (for PP pustulosis, PP pustular psoriasis, isolated pustules on palms or soles with or without erythema outside psoriatic plaques, guttate, pustular, erythrodermic, and drug-induced psoriasis) at screening or Day 1.
  • Other protocol-defined inclusion/exclusion criteria apply.

Trial locations and contacts

31 sites in 3 countries.

31 sites in 3 countries

United States20 sites
  • Local Institution - 0066

    Boardman, Ohio, 44512

  • Local Institution - 0012

    Detroit, Michigan, 48202-3141

  • Local Institution - 0005

    East Windsor, New Jersey, 08520-2505

  • Local Institution - 0015

    Fountain Valley, California, 92708

  • Local Institution - 0010

    Houston, Texas, 77004

  • Local Institution - 0052

    Indianapolis, Indiana, 46250

  • Local Institution - 0009

    Los Angeles, California, 90045-3606

  • Local Institution - 0055

    Mayfield Heights, Ohio, 44124-4005

  • Local Institution - 0033

    Mill Creek, Washington, 98012-1797

  • Local Institution - 0002

    New York, New York, 10003

  • Local Institution - 0008

    New York, New York, 10075

  • Local Institution - 0062

    New York, New York, 10128

  • Local Institution - 0007

    Norfolk, Virginia, 23502-3933

  • Local Institution - 0050

    Phoenix, Arizona, 85006-2722

  • Local Institution - 0056

    Pittsburgh, Pennsylvania, 15213-3403

  • Local Institution - 0053

    Plainfield, Indiana, 46168-2792

  • Local Institution - 0029

    Rockville, Maryland, 20850-6243

  • Local Institution - 0004

    Santa Monica, California, 90404

  • Local Institution - 0057

    Skokie, Illinois, 60077-1049

  • Local Institution - 0001

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada7 sites
  • Local Institution - 0065

    Montreal, Quebec, H1Y 3L1

  • Local Institution - 0054

    Montreal, Quebec, H2X 2V1

  • Local Institution - 0058

    Newmarket, Ontario, L3Y 5G8

  • Local Institution - 0059

    Québec, Quebec, G1W 4R4

  • Local Institution - 0061

    Saint-Jérôme, Quebec, J7Z 7E2

  • Local Institution - 0064

    Saskatoon, Saskatchewan, S7K 2C1

  • Local Institution - 0060

    Toronto, Ontario, M3B 0A7

Other trials in Canada

Argentina4 sites
  • Local Institution - 0034

    Ciudad Autonoma Buenos Aires, C, C1425DKG

  • Local Institution - 0043

    Ciudad Autónoma Buenos Aires, B, 1425

  • Local Institution - 0037

    Ciudad Autónoma Buenos Aires, B, C1428DZF

  • Local Institution - 0042

    Rosario, S, 2000

Other trials in Argentina

About this study

Official title: A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Non-Pustular PalmoPlantar and Genital Psoriasis (Psoriatyk Special Sites)

The purpose of this study is to measure the safety and effectiveness of deucravatinib in participants with non-pustular palmoplantar psoriasis and genital psoriasis.

Being tested
Deucravacitinib, Placebo
Keywords
Deucravacitinib, BMS-986165, SOTYKTU, Plaque 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, SOTYKTU

    Specified dose on specified days

  • PlaceboDrug

    Specified dose on specified days

Study groups in NCT06042920
Study groupRoleWhat they receive
DeucravacitinibExperimentalNot described
Receives: Drug: Deucravacitinib
Placebo followed by DeucravacitinibPlacebo comparatorNot described
Receives: Drug: Deucravacitinib; Drug: Placebo

What is being measured

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

  1. Percentage of Participants Achieving Palmoplantar Psoriasis Area and Severity Index (Pp-PASI)-75 Response

    PASI-75 is defined as the percentage of participants who achieve at least a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI) total score. PASI assesses erythema, thickness, and scaling of psoriatic lesions (each rated 0-4), weighted by body region involvement (head, arms, trunk, legs), producing a total score from 0-72, where higher scores indicate more severe disease. Baseline is the Week 0 assessment. PASI-75 responder defined as a 75% improvement from baseline in the PASI score.

    Measured: Week 16

  2. Percentage of Participants Achieving Static Physician's Global Assessment of Genitalia (sPGA-G) Response

    The Static Physician's Global Assessment (sPGA) OF Genitalia is a 5-point scale evaluating psoriasis severity based on erythema, scale, and induration. Scores range from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe; higher scores indicate worse disease. The sPGA-G 0/1 response is defined as the percentage of participants achieving a score of 0 or 1 with at least a 2-point improvement from baseline.

    Measured: Week 16

Secondary outcomes (5)
  1. Percentage of Participants Who Achieve a Palmoplantar Physician Global Assessment (Pp-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16

    The Palmoplantar Physician's Global Assessment (pp-PGA) is a 5-point scale evaluating psoriasis severity based on erythema, scale, and induration. Scores range from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe; higher scores indicate worse disease. The pp-PGA 0/1 response is defined as the percentage of participants achieving a score of 0 or 1 with at least a 2-point improvement from baseline.

    Measured: Week 16

  2. Change From Baseline in Genital Psoriasis Itch (GenPs) Numeric Rating Scale (NRS) Score at Week 16

    The Genital Psoriasis Symptoms Scale (GPSS) is a participant-administered questionnaire that contains 8 items regarding GenPs symptoms and has a recall period of 24 hours. The items separately address itch, pain, discomfort, stinging, burning, redness, scaling, and cracking on an 11-point scale where 0 represents "no symptom" and 10 represents "worst symptom imaginable". A total score ranging from 0 (no GenPs symptoms) to 80 (worst imaginable GenPs symptoms)

    Measured: Week 16

  3. Number of Participants With Adverse Events

    Adverse Events (AEs) are any new or worsening medical occurrences in participants receiving study treatment, regardless of whether they are related to the treatment. AEs include any unfavorable and unintended sign, symptom, or disease temporally associated with treatment. Serious Adverse Events (SAEs) are defined as events that result in death, are life-threatening, require or prolong hospitalization, cause persistent or significant disability, are congenital anomalies/birth defects, or are otherwise medically significant.

    Measured: Week 0 through Week 16

  4. Number of Participants With Worst Toxicity Grade 3 or Grade 4 Laboratory Test Results

    Blood samples were collected to assess the laboratory parameters. Laboratory toxicities are graded using NCI CTCAE v3.0. Grade 3 and 4 represent severe and life-threatening abnormalities, respectively.

    Measured: Week 0 through Week 16

  5. Number of Participants With Vital Sign Summaries Per Categories

    Vital signs assessment included heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP). Heart rate was measured in beats/min and DBP and SBP was measured in mmHG.

    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.

  1. First posted21 Sep 2023
  2. Study start9 Oct 2023
  3. Primary completion25 Apr 2025
  4. Study completion25 Apr 2025

Why it stopped: Business objectives have changed

Resources

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
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06042920
Sponsor's protocol ID
IM011-1112
Other IDs
2023-504663-16, U1111-1289-6934, 2023
Status last verified
Mar 2026
First submitted
12 Sep 2023
Last updated
17 Apr 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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/disclosure-commitment.htm

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Deucravacitinib in people with Palmoplantar Psoriasis and Genital Psoriasis, run by Bristol-Myers Squibb at 31 sites in 3 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 13 inclusion and 3 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: stopped early, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Canada, Argentina. 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 17 Apr 2026). 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 Achieving Palmoplantar Psoriasis Area and Severity Index (Pp-PASI)-75 Response (time frame: Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 17 Apr 2026.

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