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

NCT06042920 | Terminated Phase 4 Results FDA Drug

• 3 other identifiers: IM011-11122023-504663-16U1111-1289-6934
• Study Type: interventional
• Target: 130
• Locations: 3 countries
• Sites: 31

Brief 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.

Conditions

Palmoplantar Psoriasis; Genital Psoriasis

Keywords

Deucravacitinib; BMS-986165; SOTYKTU; Plaque psoriasis

Outcome Measures

Primary Outcomes (2)

• 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.

  Week 16

• 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.

  Week 16

Secondary Outcomes (5)

• 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

  Week 16

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

  Week 16

• Number of Participants With Adverse Events

  Week 0 through Week 16

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

  Week 0 through Week 16

• Number of Participants With Vital Sign Summaries Per Categories

  Week 0 through Week 16

Study Arms (2)

Deucravacitinib

EXPERIMENTAL

Drug: Deucravacitinib

Placebo followed by Deucravacitinib

PLACEBO COMPARATOR

Drug: Deucravacitinib; Drug: Placebo

Interventions

Deucravacitinib DRUG

Specified dose on specified days

Also known as: BMS-986165, SOTYKTU

Deucravacitinib; Placebo followed by Deucravacitinib

Placebo DRUG

Specified dose on specified days

Placebo followed by Deucravacitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (31)

Local Institution - 0050

Phoenix, Arizona, 85006-2722, United States

Location

Local Institution - 0015

Fountain Valley, California, 92708, United States

Location

Local Institution - 0009

Los Angeles, California, 90045-3606, United States

Location

Local Institution - 0004

Santa Monica, California, 90404, United States

Location

Local Institution - 0057

Skokie, Illinois, 60077-1049, United States

Location

Local Institution - 0052

Indianapolis, Indiana, 46250, United States

Location

Local Institution - 0053

Plainfield, Indiana, 46168-2792, United States

Location

Local Institution - 0029

Rockville, Maryland, 20850-6243, United States

Location

Local Institution - 0012

Detroit, Michigan, 48202-3141, United States

Location

Local Institution - 0005

East Windsor, New Jersey, 08520-2505, United States

Location

Local Institution - 0002

New York, New York, 10003, United States

Location

Local Institution - 0008

New York, New York, 10075, United States

Location

Local Institution - 0062

New York, New York, 10128, United States

Location

Local Institution - 0001

Winston-Salem, North Carolina, 27157, United States

Location

Local Institution - 0066

Boardman, Ohio, 44512, United States

Location

Local Institution - 0055

Mayfield Heights, Ohio, 44124-4005, United States

Location

Local Institution - 0056

Pittsburgh, Pennsylvania, 15213-3403, United States

Location

Local Institution - 0010

Houston, Texas, 77004, United States

Location

Local Institution - 0007

Norfolk, Virginia, 23502-3933, United States

Location

Local Institution - 0033

Mill Creek, Washington, 98012-1797, United States

Location

Local Institution - 0043

Ciudad Autónoma Buenos Aires, B, 1425, Argentina

Location

Local Institution - 0037

Ciudad Autónoma Buenos Aires, B, C1428DZF, Argentina

Location

Local Institution - 0034

Ciudad Autonoma Buenos Aires, C, C1425DKG, Argentina

Location

Local Institution - 0042

Rosario, S, 2000, Argentina

Location

Local Institution - 0058

Newmarket, Ontario, L3Y 5G8, Canada

Location

Local Institution - 0060

Toronto, Ontario, M3B 0A7, Canada

Location

Local Institution - 0065

Montreal, Quebec, H1Y 3L1, Canada

Location

Local Institution - 0054

Montreal, Quebec, H2X 2V1, Canada

Location

Local Institution - 0059

Québec, Quebec, G1W 4R4, Canada

Location

Local Institution - 0061

Saint-Jérôme, Quebec, J7Z 7E2, Canada

Location

Local Institution - 0064

Saskatoon, Saskatchewan, S7K 2C1, Canada

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

deucravacitinib

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: October 9, 2023
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: April 17, 2026
• Results First Posted: April 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

AR (4); US (20); CA (7)