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

Psoriasis Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05478499
• Other study ID #: IM011-220
• Secondary ID: 2022-000797-26U1
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: October 6, 2022
• Est. completion date: October 24, 2024

Study information

• Verified date: March 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 152
• Est. completion date: October 24, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Deucravacitinib
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
France	Local Institution - 0019	Paris
France	Local Institution - 0040	Romans sur Isere Cedex
France	Local Institution - 0044	Rouen Cedex
Germany	Local Institution - 0013	Frankfurt	Hessen
Germany	Local Institution - 0048	Hamburg
Germany	Local Institution - 0012	Luebeck
Germany	Local Institution - 0011	Mahlow
Germany	Local Institution - 0038	Witten	Deutschland
Poland	Local Institution - 0026	Krakow
Poland	Local Institution - 0017	Lodz
Poland	Local Institution - 0014	Rzeszow
Poland	Local Institution - 0015	Wroclaw
United Kingdom	Local Institution - 0031	London	Greater London
United Kingdom	Local Institution - 0045	Salford	Greater Manchester
United Kingdom	Local Institution - 0039	Southampton	Hampshire
United States	Local Institution - 0008	Beverly	Massachusetts
United States	Local Institution - 0047	Bloomfield Hills	Michigan
United States	Local Institution - 0049	East Windsor	New Jersey
United States	Local Institution - 0002	Fridley	Minnesota
United States	Local Institution - 0001	Hot Springs	Arkansas
United States	Local Institution - 0033	Houston	Texas
United States	Local Institution - 0007	Indianapolis	Indiana
United States	Local Institution - 0051	Kew Gardens	New York
United States	Local Institution - 0041	Louisville	Kentucky
United States	Local Institution - 0006	Norfolk	Virginia
United States	Local Institution - 0005	Pittsburgh	Pennsylvania
United States	Local Institution - 0003	Portland	Oregon
United States	Local Institution - 0022	Rockville	Maryland
United States	Local Institution - 0004	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  France,  Germany,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of Participants with Adverse Events (AEs)		At Week 16
Secondary	Number of Participants with Serious Adverse Events (SAEs)		At Week 16
Secondary	Number of Participants with Clinical Laboratory Abnormalities		At Week 16
Secondary	Number of Participants with Vital Sign Abnormalities		At Week 16

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting