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

March 27, 2026 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • B
      • Ciudad Autónoma Buenos Aires, B, Argentina, C1428DZF
        • Local Institution - 0037
      • Ciudad Autónoma Buenos Aires, B, Argentina, 1425
        • Local Institution - 0043
    • C
      • Ciudad Autonoma Buenos Aires, C, Argentina, C1425DKG
        • Local Institution - 0034
    • S
      • Rosario, S, Argentina, 2000
        • Local Institution - 0042
  • Canada
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Local Institution - 0058
      • Toronto, Ontario, Canada, M3B 0A7
        • Local Institution - 0060
    • Quebec
      • Montreal, Quebec, Canada, H1Y 3L1
        • Local Institution - 0065
      • Montreal, Quebec, Canada, H2X 2V1
        • Local Institution - 0054
      • Québec, Quebec, Canada, G1W 4R4
        • Local Institution - 0059
      • Saint-Jérôme, Quebec, Canada, J7Z 7E2
        • Local Institution - 0061
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 2C1
        • Local Institution - 0064
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006-2722
        • Local Institution - 0050
    • California
      • Fountain Valley, California, United States, 92708
        • Local Institution - 0015
      • Los Angeles, California, United States, 90045-3606
        • Local Institution - 0009
      • Santa Monica, California, United States, 90404
        • Local Institution - 0004
    • Illinois
      • Skokie, Illinois, United States, 60077-1049
        • Local Institution - 0057
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Local Institution - 0052
      • Plainfield, Indiana, United States, 46168-2792
        • Local Institution - 0053
    • Maryland
      • Rockville, Maryland, United States, 20850-6243
        • Local Institution - 0029
    • Michigan
      • Detroit, Michigan, United States, 48202-3141
        • Local Institution - 0012
    • New Jersey
      • East Windsor, New Jersey, United States, 08520-2505
        • Local Institution - 0005
    • New York
      • New York, New York, United States, 10003
        • Local Institution - 0002
      • New York, New York, United States, 10075
        • Local Institution - 0008
      • New York, New York, United States, 10128
        • Local Institution - 0062
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Local Institution - 0001
    • Ohio
      • Boardman, Ohio, United States, 44512
        • Local Institution - 0066
      • Mayfield Heights, Ohio, United States, 44124-4005
        • Local Institution - 0055
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213-3403
        • Local Institution - 0056
    • Texas
      • Houston, Texas, United States, 77004
        • Local Institution - 0010
    • Virginia
      • Norfolk, Virginia, United States, 23502-3933
        • Local Institution - 0007
    • Washington
      • Mill Creek, Washington, United States, 98012-1797
        • Local Institution - 0033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

Inclusion Criteria for Non-Pustular Palmoplantar Psoriasis

  • 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.
  • Failed to respond to, or intolerant of ≥ 1 topical therapy.

Inclusion Criteria for Genital Psoriasis

  • 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.

Key Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Deucravacitinib
Drug: Deucravacitinib
Specified dose on specified days
Other Names:
  • BMS-986165
  • SOTYKTU
Placebo Comparator: Placebo followed by Deucravacitinib
Drug: Deucravacitinib
Specified dose on specified days
Other Names:
  • BMS-986165
  • SOTYKTU
Drug: Placebo
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Palmoplantar Psoriasis Area and Severity Index (Pp-PASI)-75 Response
Time Frame: Week 16
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.
Week 16
Percentage of Participants Achieving Static Physician's Global Assessment of Genitalia (sPGA-G) Response
Time Frame: Week 16
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.
Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
Week 16
Change From Baseline in Genital Psoriasis Itch (GenPs) Numeric Rating Scale (NRS) Score at Week 16
Time Frame: 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)
Week 16
Number of Participants With Adverse Events
Time Frame: Week 0 through Week 16
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.
Week 0 through Week 16
Number of Participants With Worst Toxicity Grade 3 or Grade 4 Laboratory Test Results
Time Frame: Week 0 through Week 16
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.
Week 0 through Week 16
Number of Participants With Vital Sign Summaries Per Categories
Time Frame: Week 0 through Week 16
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.
Week 0 through Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2023

Primary Completion (Actual)

April 25, 2025

Study Completion (Actual)

April 25, 2025

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM011-1112
  • 2023-504663-16 (EudraCT Number)
  • U1111-1289-6934 (Registry Identifier: WHO Universal Trial Number (UTN))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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