A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of deucravacitinib on quality of life (QoL) in participants with plaque psoriasis in a community setting.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting

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 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. ≥ 3% of Body Surface Area (BSA) involvement at the Screening Visit and Day 1 Dermatology Life Quality Index (DLQI) score > 5 at the Screening Visit and Day 1 Moderate-to-severe plaque psoriasis as defined by static Physician Global Assessment (s-PGA) ≥ 3 at the Screening Visit and Day 1 Exclusion Criteria: Target Disease Exceptions: Non-plaque psoriasis (that is, guttate, pustular, erythrodermic, palmoplantar only involvement or drug-induced psoriasis) at Screening Visit 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 then Deucravacitinib<br> | Drug: Deucravacitinib<br>* Specified dose on specified days.<br>* Other names: Sotyktu;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 Dermatology Life Quality Index (DLQI) score 0 or 1 |  | At week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who achieve a ≥4-point reduction from baseline in DLQI |  | At week 16 | 
| Change from baseline in whole-body itch Numerical Rating Scale (NRS) score at week 16 |  | At week 16 | 
| Number of participants with a static Physician Global Assessment (s-PGA) score of 0 or 1 who had at least a 2-point reduction from baseline |  | At week 16 | 
| Number of participants with adverse events (AEs) |  | Between week 0 and week 16 | 
| Number of participants with serious adverse events (SAEs) |  | Between week 0 and week 16 | 
| Number of participants with clinical laboratory abnormalities |  | Between week 0 and week 16 | 
| Number of participants with vital sign abnormalities |  | Between week 0 and week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plaque psoriasis, deucravacitinib, BMS-986165, Health related quality of life (HrQoL), QoL (quality of life), SOTYKTU