Clinical trial NCT05701995: A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Psoriasis
Keywords: plaque psoriasis
deucravacitinib
BMS-986165
Health related quality of life (HrQoL)
QoL (quality of life)
SOTYKTU
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-01-27
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants who achieve Dermatology Life Quality Index (DLQI) score 0 or 1
timeFrame: At week 16
Secondary outcomes:
measure: Proportion of participants who achieve a ≥4-point reduction from baseline in DLQI
timeFrame: At week 16
measure: Change from baseline in whole-body itch Numerical Rating Scale (NRS) score at week 16
timeFrame: At week 16
measure: 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
timeFrame: At week 16
measure: Number of participants with adverse events (AEs)
timeFrame: Between week 0 and week 16
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Between week 0 and week 16
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Between week 0 and week 16
measure: Number of participants with vital sign abnormalities
timeFrame: Between week 0 and week 16
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Local Institution - 0006
state: Arizona
city: Scottsdale
country: United States
facility: Local Institution - 0034
state: Arizona
city: North Little Rock
country: United States
facility: Local Institution - 0015
state: Arkansas
city: Bakersfield
country: United States
facility: Local Institution - 0004
state: California
city: Sacramento
country: United States
facility: Local Institution - 0009
state: California
city: San Diego
country: United States
facility: Local Institution - 0022
state: California
city: Centennial
country: United States
facility: Local Institution - 0030
state: Colorado
city: Washington
country: United States
facility: Local Institution - 0024
state: District of Columbia
city: Brandon
country: United States
facility: Local Institution - 0027
state: Florida
city: Coral Gables
country: United States
facility: Local Institution - 0016
state: Florida
city: Pembroke Pines
country: United States
facility: Riverchase Dermatology
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0037
state: Georgia
city: Snellville
country: United States
facility: Local Institution - 0020
state: Georgia
city: Rolling Meadows
country: United States
facility: Local Institution - 0007
state: Illinois
city: Skokie
country: United States
facility: Local Institution - 0025
state: Illinois
city: Springfield
country: United States
facility: Local Institution - 0036
state: Illinois
city: Baton Rouge
country: United States
facility: Local Institution - 0003
state: Louisiana
city: Rockville
country: United States
facility: Local Institution - 0018
state: Maryland
city: Auburn Hills
country: United States
facility: Local Institution - 0010
state: Michigan
city: Waterford
country: United States
facility: Local Institution - 0002
state: Michigan
city: Las Vegas
country: United States
facility: Local Institution - 0017
state: Nevada
city: Reno
country: United States
facility: Local Institution - 0035
state: Nevada
city: New York
country: United States
facility: Local Institution - 0032
state: New York
city: New York
country: United States
facility: Local Institution - 0013
state: New York
city: Rochester
country: United States
facility: Local Institution - 0001
state: New York
city: Bexley
country: United States
facility: Local Institution - 0005
state: Ohio
city: Mayfield Heights
country: United States
facility: Local Institution - 0012
state: Ohio
city: Charleston
country: United States
facility: Local Institution - 0019
state: South Carolina
city: Cypress
country: United States
facility: Local Institution - 0029
state: Texas
city: Frisco
country: United States
facility: Local Institution - 0028
state: Texas
city: South Jordan
country: United States
facility: Local Institution - 0008
state: Utah
city: Springville
country: United States
facility: Local Institution - 0033
state: Utah
city: Bellevue
country: United States
facility: Local Institution - 0021
state: Washington
city: Mill Creek
country: United States
facility: Local Institution - 0031
state: Washington
city: Spokane
country: United States
facility: Local Institution - 0014
state: Washington
city: Caguas
country: Puerto Rico
facility: Local Institution - 0040
city: Carolina
country: Puerto Rico
facility: Local Institution - 0038
city: San Juan
country: Puerto Rico
facility: Local Institution - 0039
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: