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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05701995
Collaborator
(none)
250
Enrollment
25
Locations
2
Arms
24
Anticipated Duration (Months)
10
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jan 30, 2023
Anticipated Primary Completion Date :
Apr 22, 2024
Anticipated Study Completion Date :
Jan 29, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Deucravacitinib

Drug: Deucravacitinib
Specified dose on specified days.
Other Names:
  • BMS-986165

    		•
    Placebo Comparator: Placebo then Deucravacitinib

    Drug: Deucravacitinib
    Specified dose on specified days.
    Other Names:
  • BMS-986165

    • Other: Placebo
    Specified dose on specified days.

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of participants who achieve Dermatology Life Quality Index (DLQI) score 0 or 1 [At week 16]

    Secondary Outcome Measures

    1. Proportion of participants who achieve a ≥4-point reduction from baseline in DLQI [At week 16]

    2. Change from baseline in whole-body itch Numerical Rating Scale (NRS) score at week 16 [Baseline, Week 16]

    3. Number of participants with adverse events (AEs) [Up to week 56]

    4. Number of participants with serious adverse events (SAEs) [Up to week 56]

    5. Number of participants with clinical laboratory abnormalities [Up to week 56]

    6. Number of participants with vital sign abnormalities [Up to week 56]

    7. Number of participants with physical examination abnormalities [Up to week 56]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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 Screening Visit and Day 1

    • Dermatology Life Quality Index (DLQI) score > 5 at 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Dermatology Specialists Phoenix Arizona United States 85006
    2 Arkansas Research Trials, Inc. North Little Rock Arkansas United States 72117
    3 Bakersfield Dermatology Skin Cancer Med.Group Bakersfield California United States 93309
    4 Integrative Skin Science and Research Sacramento California United States 95815
    5 MedDerm Associates San Diego California United States 92103
    6 Foxhall Research Center Washington District of Columbia United States 20016
    7 Florida Academic Centers Research and Education, LLC Coral Gables Florida United States 33134
    8 Riverchase Dermatology Pembroke Pines Florida United States 33028
    9 Gwinnett Clinical Research Center Snellville Georgia United States 30078
    10 Arlington Dermatology SC Rolling Meadows Illinois United States 60008
    11 NorthShore University Health System Skokie Illinois United States 60077
    12 DelRicht Research Baton Rouge Louisiana United States 70809
    13 DermAssociates Rockville Maryland United States 20850
    14 Oakland Hills Dermatology PC Auburn Hills Michigan United States 48326
    15 Michigan Dermatology Institute - Waterford Waterford Michigan United States 48328
    16 JDR Dermatology Research Las Vegas Nevada United States 89148
    17 Markowitz Medical New York New York United States 10128
    18 Skin Search of Rochester Rochester New York United States 14623
    19 Bexley Dermatology Research Bexley Ohio United States 43209
    20 Apex Clinical Research Center Mayfield Heights Ohio United States 44124
    21 DermDox Centers for Dermatology Sugarloaf Pennsylvania United States 18249
    22 Clinical Research Center of the Carolinas Charleston South Carolina United States 29407
    23 Jordan Valley Dermatology and Research Center South Jordan Utah United States 84095
    24 Bellevue Dermatology Clinic Bellevue Washington United States 98004
    25 Premier Clinical Research LLC Spokane Washington United States 99202

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05701995
    Other Study ID Numbers:
    • IM011-237
    • U1111-1276-5158
    First Posted:
    Jan 27, 2023
    Last Update Posted:
    Jan 27, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    plaque psoriasis
    deucravacitinib
    BMS-986165
    Health related quality of life (HrQoL)
    QoL (quality of life)
    SOTYKTU
    Additional relevant MeSH terms:
    Psoriasis
    BMS-986165

    Study Results

    No Results Posted as of Jan 27, 2023