Deucravacitinib Post-marketing Surveillance in Patients With Psoriasis in Japan

Bristol-Myers Squibb1 site in 1 country369 target enrollmentDecember 5, 2022

ConditionsPsoriasis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Psoriasis
Sponsor: Bristol-Myers Squibb
Enrollment: 369
Locations: 1
Primary Endpoint: Incidence of Adverse Events (AEs)
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 5, 2022

End Date

May 28, 2025

Last Updated

10 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Incidence of Adverse Events (AEs)

Time Frame: Up to 52 weeks

Secondary Outcomes

Change from Baseline in Body Surface Area (BSA) during study period(Up to 52 weeks)
Distribution of demographic characteristics: Age(Up to 52 weeks)
Distribution of demographic characteristics: Height(Up to 52 weeks)
Proportion of participants achieving Static Physicians Global Assessment (sPGA) of 0/1 during study period(Up to 52 weeks)
Distribution of demographic characteristics: Sex(Up to 52 weeks)
Distribution of demographic characteristics: Weight(Up to 52 weeks)
Distribution of demographic characteristics: Past history /complication(Up to 52 weeks)
Proportion of participants achieving Global Improvement Score (GIS) during study period(Up to 52 weeks)