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A Study to Assess Deucravacitinib Post-marketing Surveillance in Participants With Psoriasis in Japan

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05633264
Collaborator
(none)
300
Enrollment
1
Location
30
Anticipated Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety and effectiveness of deucravacitinib for the treatment of plaque psoriasis (PsO) in Japan participants.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Deucravacitinib Post-marketing Surveillance in Patients With Psoriasis in Japan
    Anticipated Study Start Date :
    Dec 1, 2022
    Anticipated Primary Completion Date :
    May 31, 2025
    Anticipated Study Completion Date :
    May 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort 1

    Psoriasis (PsO) participants who initiate treatment with Deucravacitinib.

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Adverse Events (AEs) [Up to 52 weeks]

    Secondary Outcome Measures

    1. Proportion of participants achieving Static Physicians Global Assessment (sPGA) of 0/1 during study period [Up to 52 weeks]

    2. Change from Baseline in Body Surface Area (BSA) during study period [Up to 52 weeks]

    3. Proportion of participants achieving Global Improvement Score (GIS) during study period [Up to 52 weeks]

    4. Distribution of demographic characteristics: Age [Up to 52 weeks]

    5. Distribution of demographic characteristics: Sex [Up to 52 weeks]

    6. Distribution of demographic characteristics: Height [Up to 52 weeks]

    7. Distribution of demographic characteristics: Weight [Up to 52 weeks]

    8. Distribution of demographic characteristics: Past history /complication [Up to 52 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Psoriasis (PsO) participants who received Deucravacitinib for the first time of the approved indications at medical institutions in Japan will be enrolled in this PMS
    Exclusion Criteria:
    • Participants receiving Deucravacitinib for an off-label indication will be excluded from this PMS.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Tosima-ku Tokyo Japan 171-0021

    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:
    NCT05633264
    Other Study ID Numbers:
    • IM011-226
    First Posted:
    Dec 1, 2022
    Last Update Posted:
    Dec 1, 2022
    Last Verified:
    Nov 1, 2022
    Keywords provided by Bristol-Myers Squibb
    Psoriasis
    Deucravacitinib
    Additional relevant MeSH terms:
    Psoriasis

    Study Results

    No Results Posted as of Dec 1, 2022