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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05478499

Collaborator

(none)

150

Enrollment

Locations

Arms

22.5

Anticipated Duration (Months)

37.5

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: Deucravacitinib Other: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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)

Anticipated Study Start Date :

Aug 8, 2022

Anticipated Primary Completion Date :

Sep 18, 2023

Anticipated Study Completion Date :

Jun 24, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Deucravacitinib	Drug: Deucravacitinib Specified dose on specified days Other Names: BMS-986165
Placebo Comparator: Placebo	Other: Placebo Specified dose on specified days

Arm

Intervention/Treatment

Experimental: Deucravacitinib

Drug: Deucravacitinib

Specified dose on specified days

Other Names:

BMS-986165

Placebo Comparator: Placebo

Other: Placebo

Specified dose on specified days

Outcome Measures

Primary Outcome Measures

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

Proportion of Participants Who Achieve Psoriasis Scalp Severity Index (PSSI) Response 90 [At Week 16]
At least 90% improvement from baseline in the PSSI score.
Change from Baseline in Scalp-specific Itch Numeric Rating Scale (NRS) Score [At Week 16]
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.
Number of Participants with Adverse Events (AEs) [Up to 56 Weeks]
Number of Participants with Serious Adverse Events (SAEs) [Up to 56 Weeks]
Number of Participants with Clinical Laboratory Abnormalities [Up to 56 Weeks]
Number of Participants with Physical Examination Abnormalities [Up to 56 Weeks]
Number of Participants with Vital Sign Abnormalities [Up to 56 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Scalp-specific Physician's Global Assessment (ss-PGA) ≥ 3; ≥ 20% scalp surface area (SSA); Psoriasis Scalp Severity Index (PSSI) ≥ 12 at Screening visit and Day 1
≥ 3% of Body Surface Area (BSA) involvement at 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana	United States	46250
2	Local Institution - 0035	Mahlow	Brandenburg	Germany	15831
3	Local Institution - 0027	Rzeszow	Subcarpathian Voivodeship	Poland	35-055
4	Local Institution - 0036	Wroclaw		Poland	51-685