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

NCT ID: NCT05701995

Last Updated: 2025-09-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2025-05-29

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Deucravacitinib

Group Type EXPERIMENTAL

Deucravacitinib

Intervention Type DRUG

Specified dose on specified days.

Placebo then Deucravacitinib

Group Type PLACEBO_COMPARATOR

Deucravacitinib

Intervention Type DRUG

Specified dose on specified days.

Placebo

Intervention Type OTHER

Specified dose on specified days.

Interventions

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Deucravacitinib

Specified dose on specified days.

Intervention Type DRUG

Placebo

Specified dose on specified days.

Intervention Type OTHER

Other Intervention Names

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BMS-986165 Sotyktu

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0006

Phoenix, Arizona, United States

Site Status

Local Institution - 0034

Scottsdale, Arizona, United States

Site Status

Local Institution - 0015

North Little Rock, Arkansas, United States

Site Status

Local Institution - 0004

Bakersfield, California, United States

Site Status

Local Institution - 0009

Sacramento, California, United States

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Local Institution - 0022

San Diego, California, United States

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Local Institution - 0030

Centennial, Colorado, United States

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Local Institution - 0024

Washington D.C., District of Columbia, United States

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Local Institution - 0027

Brandon, Florida, United States

Site Status

Local Institution - 0016

Coral Gables, Florida, United States

Site Status

Riverchase Dermatology

Pembroke Pines, Florida, United States

Site Status

Local Institution - 0037

Atlanta, Georgia, United States

Site Status

Local Institution - 0020

Snellville, Georgia, United States

Site Status

Local Institution - 0007

Rolling Meadows, Illinois, United States

Site Status

Local Institution - 0025

Skokie, Illinois, United States

Site Status

Local Institution - 0036

Springfield, Illinois, United States

Site Status

Local Institution - 0003

Baton Rouge, Louisiana, United States

Site Status

Local Institution - 0018

Rockville, Maryland, United States

Site Status

Local Institution - 0010

Auburn Hills, Michigan, United States

Site Status

Local Institution - 0002

Waterford, Michigan, United States

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Local Institution - 0017

Las Vegas, Nevada, United States

Site Status

Local Institution - 0035

Reno, Nevada, United States

Site Status

Local Institution - 0032

New York, New York, United States

Site Status

Local Institution - 0013

New York, New York, United States

Site Status

Local Institution - 0001

Rochester, New York, United States

Site Status

Local Institution - 0005

Bexley, Ohio, United States

Site Status

Local Institution - 0012

Mayfield Heights, Ohio, United States

Site Status

Local Institution - 0019

Charleston, South Carolina, United States

Site Status

Local Institution - 0029

Cypress, Texas, United States

Site Status

Local Institution - 0028

Frisco, Texas, United States

Site Status

Local Institution - 0008

South Jordan, Utah, United States

Site Status

Local Institution - 0033

Springville, Utah, United States

Site Status

Local Institution - 0021

Bellevue, Washington, United States

Site Status

Local Institution - 0031

Mill Creek, Washington, United States

Site Status

Local Institution - 0014

Spokane, Washington, United States

Site Status

Local Institution - 0040

Caguas, , Puerto Rico

Site Status

Local Institution - 0038

Carolina, , Puerto Rico

Site Status

Local Institution - 0039

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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U1111-1276-5158

Identifier Type: REGISTRY

Identifier Source: secondary_id

IM011-237

Identifier Type: -

Identifier Source: org_study_id

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