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

Bristol-Myers Squibb154 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

154

Conditions

Psoriasis

Interventions

DeucravacitinibDRUG

Specified dose on specified days

PlaceboOTHER

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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 2. Deemed by the Investigator to be a candidate for phototherapy or systemic therapy 3. 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 4. ≥ 3% of Body Surface Area (BSA) involvement at the Screening visit and Day 1 5. Evidence of plaque psoriasis in a non-scalp area 6. Failed to respond to, or intolerant of ≥ 1 topical therapy for scalp psoriasis Exclusion Criteria: * Target Disease Exceptions: 1. Has nonplaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-induced psoriasis) at Screening or Day 1 Other protocol-defined inclusion/exclusion criteria apply

Locations (29)

Outcomes

Primary Outcomes

Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16

ss-PGA 0/1 response as a percentage of participants with an ss-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. Scalp lesions are evaluated in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease.

Time frame: Baseline and Week 16

Secondary Outcomes

Percentage of Participants With a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16

PSSI 90 response as a percentage of participants who achieve at least 90% improvement from baseline in the PSSI score at Week 16. PSSI assesses severity of scalp disease in participants with scalp involvement with a 5-point Likert-type scale on the clinical parameters of erythema, induration, and desquamation. The scores are summed and multiplied by an integer (0 to 6) that represents the area of affected scalp. The PSSI score ranges from 0 to 72 with higher scores indicating more severe symptoms.

Time frame: Baseline and Week 16

Change From Baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16

Change from baseline in scalp-specific itch numerical rating scale (NRS) score at week 16. The scalp-specific itch NRS is an 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 within the past 24 hours.

Time frame: Baseline and Week 16

Percentage of Participants With a Static Physician Global Assessment Score of 0 or 1 (s-PGA 0/1) at Week 16

s-PGA 0/1 response as a percentage of participants with an s-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. The s-PGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The s-PGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4).

Data from ClinicalTrials.gov

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