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

Palmoplantar Psoriasis Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06042920
• Other study ID #: IM011-1112
• Secondary ID: 2023-504663-16U1
• Status: Recruiting
• Phase: Phase 4
• Start date: October 10, 2023
• Est. completion date: April 22, 2026

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: First Name: BMS Study Connect Contact Center Last Name: www.BMSS
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: April 22, 2026
• Est. primary completion date: July 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Genital Psoriasis
• Palmoplantar Psoriasis
• Psoriasis

Intervention

Drug:
• Deucravacitinib
Specified dose on specified days
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Psoriahue	Ciudad Autonoma Buenos Aires	C
Argentina	Consultorios Reumatológicos Pampa	Ciudad Autónoma Buenos Aires	B
Argentina	Instituto de Neumonologia y Dermatologia	Ciudad Autónoma Buenos Aires	B
Argentina	Instituto de Especialidades de la Salud Rosario	Rosario	S
Canada	Local Institution - 0054	Montreal	Quebec
Canada	Local Institution - 0065	Montreal	Quebec
Canada	Local Institution - 0058	Newmarket	Ontario
Canada	Local Institution - 0063	Niagara Falls	Ontario
Canada	Local Institution - 0059	Québec	Quebec
Canada	Local Institution - 0061	Saint-Jerome	Quebec
Canada	Local Institution - 0064	Saskatoon	Saskatchewan
Canada	Local Institution - 0060	Toronto	Ontario
Germany	Local Institution - 0028	Berlin	BE
Germany	Local Institution - 0017	Frankfurt am Main	Hesse
Germany	Local Institution - 0016	Hamburg	HH
Germany	Local Institution - 0014	Mainz	RP
Germany	Local Institution - 0030	Memmingen	BY
Germany	Local Institution - 0013	Witten	Northwest
Germany	Local Institution - 0027	Witten	Northwest
Germany	Local Institution - 0045	Witten	Northwest
Italy	Local Institution - 0040	Brescia	BS
Italy	Local Institution - 0039	Roma	RM
Poland	Local Institution - 0035	Bialystok	PD
Poland	Local Institution - 0032	Rzeszow	PK
Poland	Local Institution - 0038	Warsaw	Mazowieckie
Poland	Local Institution - 0031	Warszawa	Mazowieckie
Poland	Local Institution - 0036	Wroclaw	DS
Spain	Local Institution - 0011	Barcelona
Spain	Local Institution - 0023	Barcelona
Spain	Local Institution - 0018	Córdoba	X
Spain	Local Institution - 0024	Madrid	M
United States	Local Institution - 0022	Birmingham	Alabama
United States	Local Institution - 0066	Boardman	Ohio
United States	Clinical Research Center of the Carolinas	Charleston	South Carolina
United States	Local Institution - 0003	Charleston	South Carolina
United States	Henry Ford Medical Center	Detroit	Michigan
United States	Henry Ford Medical Center - New Center One	Detroit	Michigan
United States	Schweiger Dermatology Group - East Windsor - Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey
United States	Windsor Dermatology - Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey
United States	First OC Dermatology - Fountain Valley	Fountain Valley	California
United States	Center for Clinical Studies-TMC	Houston	Texas
United States	Local Institution - 0047	Houston	Texas
United States	Local Institution - 0052	Indianapolis	Indiana
United States	Dermatology Research Associates - Howard Sofen, MD	Los Angeles	California
United States	Dermatology Research Associates - Howard Sofen, MD	Los Angeles	California
United States	Local Institution - 0055	Mayfield Heights	Ohio
United States	North Sound Dermatology - Mill Creek	Mill Creek	Washington
United States	Local Institution - 0044	New York	New York
United States	Local Institution - 0049	New York	New York
United States	Local Institution - 0062	New York	New York
United States	Sadick Dermatology	New York	New York
United States	Virginia Clinical Research	Norfolk	Virginia
United States	Virginia Clinical Research	Norfolk	Virginia
United States	Local Institution - 0050	Phoenix	Arizona
United States	Local Institution - 0056	Pittsburgh	Pennsylvania
United States	Local Institution - 0053	Plainfield	Indiana
United States	Local Institution - 0021	Portland	Oregon
United States	U.S. Dermatology Partners Rockville	Rockville	Maryland
United States	Local Institution - 0051	Rolling Meadows	Illinois
United States	Clinical Science Institute	Santa Monica	California
United States	Local Institution - 0048	Santa Monica	California
United States	Local Institution - 0057	Skokie	Illinois
United States	Local Institution - 0046	Winston-Salem	North Carolina
United States	Wake Forest University School Of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Germany,  Italy,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a 75% Improvement in Palmoplantar Psoriasis Area and Severity Index (pp-PASI-75) Score		Baseline to Week 16
Primary	Number of Participants With Static Physician Global Assessment Genitals (s-PGA-G) Score of 0 (Clear ) or 1 (Almost Clear), With At Least a 2-Point Reduction		Baseline to Week 16
Secondary	Number of Participants With Palmoplantar Physician Global Assessment (pp-PGA) Score of 0 (Clear) or 1 (Almost Clear), With At Least a 2-Point Reduction		Baseline to Week 16
Secondary	Number of Participants With Static Physician Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear), With Least a 2-Point Reduction		Baseline to Week 16
Secondary	Change from baseline in Genital Psoriasis (GenPs) Itch Numeric Rating Scale (NRS) score		Baseline to Week 16
Secondary	Number of Participants With Adverse Events (AEs)		Up to Week 16
Secondary	Number of Participants With Serious Adverse Events (SAEs)		Up to Week 16
Secondary	Number of Participants With Clinical Laboratory Abnormalities		Up to Week 16
Secondary	Number of Participants With Vital Sign Abnormalities		Up to Week 16

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting