Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and safety of deucravacitinib to placebo in participants with moderate-to-severe scalp psoriasis.

Official Title
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A Phase 3B/4, Multicenter, Randomized, Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Moderate-to-severe Scalp Psoriasis (PSORIATYK SCALP)

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Deucravacitinib
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women diagnosed with stable plaque psoriasis with scalp involvement for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the Investigator Deemed by the Investigator to be a candidate for phototherapy or systemic therapy Moderate-to-severe scalp psoriasis as defined by scalp-specific Physician's Global Assessment (ss-PGA) ≥ 3; ≥ 20% scalp surface area (SSA); Psoriasis Scalp Severity Index (PSSI) ≥ 12 at the Screening visit and Day 1 ≥ 3% of Body Surface Area (BSA) involvement at the Screening visit and Day 1 Evidence of plaque psoriasis in a non-scalp area Failed to respond to, or intolerant of ≥ 1 topical therapy for scalp psoriasis Exclusion Criteria: Target Disease Exceptions: Has nonplaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or 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: BMS-986165;|
| Placebo Comparator: Placebo then Deucravacitinib<br> | Drug: Deucravacitinib<br>* Specified dose on specified days<br>* Other names: BMS-986165;Other: 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 |
| --- | --- | --- |
| Proportion of Participants Who Achieve Scalp-Specific Physician's Global Assessment (ss-PGA) Score 0 (clear) or 1 (almost clear) with at least a 2-point Reduction from Baseline |  | At Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Who Achieve Psoriasis Scalp Severity Index (PSSI) Response 90 | At least 90% improvement from baseline in the PSSI score. | At Week 16 | 
| Change from Baseline in Scalp-specific Itch Numeric Rating Scale (NRS) Score | The Scalp Itch NRS is a participant administered, 11-point horizontal scale anchored at 0 and 10 with 0 representing no scalp itch and 10 representing worst scalp itch imaginable. Overall severity of a participant's itching from scalp psoriasis is indicated by selecting the number that best describes the worst level of scalp itching in the past 24 hours. | At Week 16 | 
| Proportion of Participants Who Achieve static Physician's Global Assessment (s-PGA) Score 0 (clear) or 1 (almost clear) with at least a 2-point Reduction from Baseline |  | At Week 16 | 
| Number of Participants with Adverse Events (AEs) |  | At Week 16 | 
| Number of Participants with Serious Adverse Events (SAEs) |  | At Week 16 | 
| Number of Participants with Clinical Laboratory Abnormalities |  | At Week 16 | 
| Number of Participants with Vital Sign Abnormalities |  | At Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scalp Psoriasis, BMS-986165, Deucravacitinib, Psoriasis, Psoriasis Special Sites