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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Other: Placebo; Drug: Deucravacitinib

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 4

Contacts and Locations

Study Locations

• Puerto Rico
  • Caguas, Puerto Rico, 00727
    • Local Institution - 0040
  • Carolina, Puerto Rico, 00985
    • Local Institution - 0038
  • San Juan, Puerto Rico, 00917
    • Local Institution - 0039
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Local Institution - 0006
    • Scottsdale, Arizona, United States, 85260
      • Local Institution - 0034
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Local Institution - 0015
  • California
    • Bakersfield, California, United States, 93309
      • Local Institution - 0004
    • Sacramento, California, United States, 95815
      • Local Institution - 0009
    • San Diego, California, United States, 92103
      • Local Institution - 0022
  • Colorado
    • Centennial, Colorado, United States, 80111
      • Local Institution - 0030
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20016
      • Local Institution - 0024
  • Florida
    • Brandon, Florida, United States, 33511
      • Local Institution - 0027
    • Coral Gables, Florida, United States, 33134
      • Local Institution - 0016
    • Pembroke Pines, Florida, United States, 33028
      • Riverchase Dermatology
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Local Institution - 0037
    • Snellville, Georgia, United States, 30078
      • Local Institution - 0020
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Local Institution - 0007
    • Skokie, Illinois, United States, 60077
      • Local Institution - 0025
    • Springfield, Illinois, United States, 62703
      • Local Institution - 0036
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Local Institution - 0003
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Local Institution - 0018
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • Local Institution - 0010
    • Waterford, Michigan, United States, 48328
      • Local Institution - 0002
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Local Institution - 0017
    • Reno, Nevada, United States, 89509
      • Local Institution - 0035
  • New York
    • New York, New York, United States, 10011
      • Local Institution - 0032
    • New York, New York, United States, 10128
      • Local Institution - 0013
    • Rochester, New York, United States, 14623
      • Local Institution - 0001
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Local Institution - 0005
    • Mayfield Heights, Ohio, United States, 44124
      • Local Institution - 0012
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Local Institution - 0019
  • Texas
    • Cypress, Texas, United States, 77433
      • Local Institution - 0029
    • Frisco, Texas, United States, 75034
      • Local Institution - 0028
  • Utah
    • South Jordan, Utah, United States, 84095
      • Local Institution - 0008
    • Springville, Utah, United States, 84663
      • Local Institution - 0033
  • Washington
    • Bellevue, Washington, United States, 98004
      • Local Institution - 0021
    • Mill Creek, Washington, United States, 98012
      • Local Institution - 0031
    • Spokane, Washington, United States, 99202
      • Local Institution - 0014

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deucravacitinib	Drug: Deucravacitinib; Specified dose on specified days.; Other Names: BMS-986165; Sotyktu
Placebo Comparator: Placebo then Deucravacitinib	Other: Placebo; Specified dose on specified days.; Drug: Deucravacitinib; Specified dose on specified days.; Other Names: BMS-986165; Sotyktu

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; a little; a lot; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16	The Dermatology Life Quality Index (DLQI) is a simple, 10-question survey used to measure the impact of skin conditions on a patient's quality of life. It assesses how much a skin condition affects various aspects of daily life, including symptoms, feelings, daily activities, work or school, personal relationships, and treatment. The DLQI is scored by summing the responses to its 10 questions. Each question is scored on a scale from 0 to 3: 0 = Not at all; = A little; = A lot; = Very much The total score ranges from 0 to 30, with higher scores indicating a greater impact on the patient's quality of life.	At Week 16
Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16	The whole-body itch Numerical Rating Scale (NRS) is a survey that participants fill out themselves. It uses an 11-point scale from 0 to 10, where 0 means 'no itch' and 10 means 'worst itch imaginable.' Participants indicate the severity of their itching from psoriasis by selecting the number that best describes the worst level of itching they experienced in the past 24 hours. A lower score means better outcomes, indicating less severe itching.	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	The Static Physician's Global Assessment (s-PGA) is a 5-point scale to evaluate the average severity of all psoriatic lesions based on redness, scaling, and thickness. The s-PGA measures psoriasis severity at a single point in time, without considering the initial condition. The scale rates the severity as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A lower score means better outcomes, indicating less severe psoriasis.	At Week 16
Number of Participants With Treatment Emergent Adverse Events (AEs) From Week 0 to Week 16	An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.	From Week 0 through Week 16
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) From Week 0 to Week 16	Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.	From Week 0 through Week 16
Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16	Number of participants with laboratory abnormalities in potential drug-induced liver injury tests. ALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper limit of normal	From Week 0 through Week 16
Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16	Blood samples were collected to assess the abnormalities in laboratory parameters. The laboratory parameters were graded by Common Terminology Criteria for Adverse Events (CTCAE). Grade 3=Severe; Grade 4=Life-threatening.	From Week 0 through Week 16
Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16	Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure.	From Week 0 through Week 16
Number of Participants With Clinically Significant Changes in Vital Signs From Week 0 to Week 16	Vital Sign Measurements include: Body Temperature (C), Respiratory Rate (breaths/min), Seated Blood Pressure (mmHg) and Heart Rate (beats/min). Clinically significant changes in these measurements may need medical attention as they could indicate a potential health concern.	From Week 0 through Week 16

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2023
• Primary Completion (Actual): August 23, 2024
• Study Completion (Actual): May 29, 2025

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: BMS-986165; plaque psoriasis; deucravacitinib; Health related quality of life (HrQoL); QoL (quality of life); SOTYKTU
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs; deucravacitinib
• Other Study ID Numbers: IM011-237; U1111-1276-5158 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol-Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No