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Completed

NCT Number: NCT05701995

A Study to Evaluate 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Local Institution - 0040, Caguas, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deucravacitinib

Drug

Specified dose on specified days.

Other names: BMS-986165, Sotyktu

Placebo

Other

Specified dose on specified days.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.
  2. Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16

    Time frame: Baseline and 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.

  3. 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

    Time frame: 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.

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

    Time frame: From Week 0 through 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.

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

    Time frame: From Week 0 through 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.

  6. Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16

    Time frame: From Week 0 through 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

  7. Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16

    Time frame: From Week 0 through 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.

  8. Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16

    Time frame: From Week 0 through Week 16

    Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure.

  9. Number of Participants With Clinically Significant Changes in Vital Signs From Week 0 to Week 16

    Time frame: From Week 0 through 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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Acronym: ARTISTYK

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 27, 2023
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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