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

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

Official Title
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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)

Conditions
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Palmoplantar Psoriasis, Genital Psoriasis

Intervention / Treatment
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* Drug: Deucravacitinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deucravacitinib<br> | Drug: Deucravacitinib<br>* Specified dose on specified days<br>* Other names: SOTYKTU;|
| Placebo Comparator: Placebo followed by Deucravacitinib<br> | Drug: Deucravacitinib<br>* Specified dose on specified days<br>* Other names: SOTYKTU;Drug: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a 75% Improvement in Palmoplantar Psoriasis Area and Severity Index (pp-PASI-75) Score |  | Baseline to Week 16 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Change from baseline in Genital Psoriasis (GenPs) Itch Numeric Rating Scale (NRS) score |  | Baseline to Week 16 | 
| Number of Participants With Adverse Events (AEs) |  | Up to Week 16 | 
| Number of Participants With Serious Adverse Events (SAEs) |  | Up to Week 16 | 
| Number of Participants With Clinical Laboratory Abnormalities |  | Up to Week 16 | 
| Number of Participants With Vital Sign Abnormalities |  | Up to Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deucravacitinib, BMS-986165, SOTYKTU, Plaque psoriasis