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

NCT05701995 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: IM011-237U1111-1276-5158
• Study Type: interventional
• Target: 180
• Locations: 2 countries
• Sites: 38

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.

Conditions

Psoriasis

Keywords

plaque psoriasis; deucravacitinib; BMS-986165; Health related quality of life (HrQoL); QoL (quality of life); SOTYKTU

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16

  Dermatology Life Quality Index (DLQI) is a participant-reported Quality of Life (QoL) survey which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a 4-point scale: 0=not at all 1. a little 2. a lot 3. very much The scores are added up to give a total score between 0 and 30. A lower total score means a better quality of life.

  At Week 16

Secondary Outcomes (9)

• Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

  At Week 16

• Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16

  Baseline and at Week 16

• Percentage of Participants With a Static Physician's Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16

  At Week 16

• Number of Participants With Treatment Emergent Adverse Events (AEs) From Week 0 to Week 16

  From Week 0 through Week 16

• Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) From Week 0 to Week 16

  From Week 0 through Week 16

Study Arms (2)

Deucravacitinib

EXPERIMENTAL

Drug: Deucravacitinib

Placebo then Deucravacitinib

PLACEBO COMPARATOR

Drug: Deucravacitinib; Other: Placebo

Interventions

Deucravacitinib DRUG

Specified dose on specified days.

Also known as: BMS-986165, Sotyktu

Deucravacitinib; Placebo then Deucravacitinib

Placebo OTHER

Specified dose on specified days.

Placebo then Deucravacitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Target Disease Exceptions:
• Non-plaque psoriasis (that is, guttate, pustular, erythrodermic, palmoplantar only involvement or drug-induced psoriasis) at Screening Visit or Day 1

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (38)

Local Institution - 0006

Phoenix, Arizona, 85006, United States

Location

Local Institution - 0034

Scottsdale, Arizona, 85260, United States

Location

Local Institution - 0015

North Little Rock, Arkansas, 72117, United States

Location

Local Institution - 0004

Bakersfield, California, 93309, United States

Location

Local Institution - 0009

Sacramento, California, 95815, United States

Location

Local Institution - 0022

San Diego, California, 92103, United States

Location

Local Institution - 0030

Centennial, Colorado, 80111, United States

Location

Local Institution - 0024

Washington D.C., District of Columbia, 20016, United States

Location

Local Institution - 0027

Brandon, Florida, 33511, United States

Location

Local Institution - 0016

Coral Gables, Florida, 33134, United States

Location

Riverchase Dermatology

Pembroke Pines, Florida, 33028, United States

Location

Local Institution - 0037

Atlanta, Georgia, 30331, United States

Location

Local Institution - 0020

Snellville, Georgia, 30078, United States

Location

Local Institution - 0007

Rolling Meadows, Illinois, 60008, United States

Location

Local Institution - 0025

Skokie, Illinois, 60077, United States

Location

Local Institution - 0036

Springfield, Illinois, 62703, United States

Location

Local Institution - 0003

Baton Rouge, Louisiana, 70809, United States

Location

Local Institution - 0018

Rockville, Maryland, 20850, United States

Location

Local Institution - 0010

Auburn Hills, Michigan, 48326, United States

Location

Local Institution - 0002

Waterford, Michigan, 48328, United States

Location

Local Institution - 0017

Las Vegas, Nevada, 89148, United States

Location

Local Institution - 0035

Reno, Nevada, 89509, United States

Location

Local Institution - 0032

New York, New York, 10011, United States

Location

Local Institution - 0013

New York, New York, 10128, United States

Location

Local Institution - 0001

Rochester, New York, 14623, United States

Location

Local Institution - 0005

Bexley, Ohio, 43209, United States

Location

Local Institution - 0012

Mayfield Heights, Ohio, 44124, United States

Location

Local Institution - 0019

Charleston, South Carolina, 29407, United States

Location

Local Institution - 0029

Cypress, Texas, 77433, United States

Location

Local Institution - 0028

Frisco, Texas, 75034, United States

Location

Local Institution - 0008

South Jordan, Utah, 84095, United States

Location

Local Institution - 0033

Springville, Utah, 84663, United States

Location

Local Institution - 0021

Bellevue, Washington, 98004, United States

Location

Local Institution - 0031

Mill Creek, Washington, 98012, United States

Location

Local Institution - 0014

Spokane, Washington, 99202, United States

Location

Local Institution - 0040

Caguas, 00727, Puerto Rico

Location

Local Institution - 0038

Carolina, 00985, Puerto Rico

Location

Local Institution - 0039

San Juan, 00917, Puerto Rico

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Psoriasis

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: January 27, 2023
• Study Start: January 31, 2023
• Primary Completion: August 23, 2024
• Study Completion: May 29, 2025
• Last Updated: September 10, 2025
• Results First Posted: September 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (35); PR (3)