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

Psoriasis Clinical Trial

— ARTISTYK  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05701995
• Other study ID #: IM011-237
• Secondary ID: U1111-1276-5158
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 31, 2023
• Est. completion date: May 27, 2025

Study information

• Verified date: May 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 evaluate the effect of deucravacitinib on quality of life (QoL) in participants with plaque psoriasis in a community setting.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 174
• Est. completion date: May 27, 2025
• Est. primary completion date: August 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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
Puerto Rico	Local Institution - 0040	Caguas
Puerto Rico	Local Institution - 0038	Carolina
Puerto Rico	Local Institution - 0039	San Juan
United States	Local Institution - 0037	Atlanta	Georgia
United States	Local Institution - 0010	Auburn Hills	Michigan
United States	Local Institution - 0004	Bakersfield	California
United States	Local Institution - 0003	Baton Rouge	Louisiana
United States	Local Institution - 0021	Bellevue	Washington
United States	Local Institution - 0005	Bexley	Ohio
United States	Local Institution - 0027	Brandon	Florida
United States	Local Institution - 0030	Centennial	Colorado
United States	Local Institution - 0019	Charleston	South Carolina
United States	Local Institution - 0016	Coral Gables	Florida
United States	Local Institution - 0029	Cypress	Texas
United States	Local Institution - 0028	Frisco	Texas
United States	Local Institution - 0017	Las Vegas	Nevada
United States	Local Institution - 0012	Mayfield Heights	Ohio
United States	Local Institution - 0031	Mill Creek	Washington
United States	Local Institution - 0013	New York	New York
United States	Local Institution - 0032	New York	New York
United States	Local Institution - 0015	North Little Rock	Arkansas
United States	Riverchase Dermatology	Pembroke Pines	Florida
United States	Local Institution - 0006	Phoenix	Arizona
United States	Local Institution - 0035	Reno	Nevada
United States	Local Institution - 0001	Rochester	New York
United States	Local Institution - 0018	Rockville	Maryland
United States	Local Institution - 0007	Rolling Meadows	Illinois
United States	Local Institution - 0009	Sacramento	California
United States	Local Institution - 0022	San Diego	California
United States	Local Institution - 0034	Scottsdale	Arizona
United States	Local Institution - 0025	Skokie	Illinois
United States	Local Institution - 0020	Snellville	Georgia
United States	Local Institution - 0008	South Jordan	Utah
United States	Local Institution - 0014	Spokane	Washington
United States	Local Institution - 0036	Springfield	Illinois
United States	Local Institution - 0033	Springville	Utah
United States	DermDox Centers for Dermatology	Sugarloaf	Pennsylvania
United States	Local Institution - 0024	Washington	District of Columbia
United States	Local Institution - 0002	Waterford	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants who achieve Dermatology Life Quality Index (DLQI) score 0 or 1		At week 16
Secondary	Proportion of participants who achieve a =4-point reduction from baseline in DLQI		At week 16
Secondary	Change from baseline in whole-body itch Numerical Rating Scale (NRS) score at week 16		At week 16
Secondary	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
Secondary	Number of participants with adverse events (AEs)		Between week 0 and week 16
Secondary	Number of participants with serious adverse events (SAEs)		Between week 0 and week 16
Secondary	Number of participants with clinical laboratory abnormalities		Between week 0 and week 16
Secondary	Number of participants with vital sign abnormalities		Between week 0 and week 16

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting