A Prospective Observational Study to Evaluate the Effectiveness of Deucravacitinib in Patients With Moderate Plaque Psoriasis in Real-World Settings in China (ADMIRE)

Bristol-Myers Squibb6 sites in 1 country153 target enrollmentJanuary 20, 2025

ConditionsPlaque Psoriasis

InterventionsDeucravacitinib

DrugsDeucravacitinib

Overview

Phase: N/A
Intervention: Deucravacitinib
Conditions: Plaque Psoriasis
Sponsor: Bristol-Myers Squibb
Enrollment: 153
Locations: 6
Primary Endpoint: Number of participants achieving Static Physician's Global Assessment (sPGA) 0/1 score
Status: Active, Not Recruiting
Last Updated: 17 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to collect and evaluate real-world data on the effectiveness of deucravacitinib treatment in adults with moderate plaque psoriasis in China.

Registry

clinicaltrials.gov

Start Date

January 20, 2025

End Date

March 11, 2027

Last Updated

17 days ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participant aged 18 years or older
•Physician-reported (dermatologist) diagnosis of moderate plaque psoriasis with Body Surface Area ≥ 3% and \< 10%
•Participant newly initiated deucravacitinib according to the label
•Provided written informed consent to participate in the study

Exclusion Criteria

•Participating in or planning to participate in an interventional clinical trial
•Concomitant use of other systemic treatments for psoriasis at baseline
•Prior treatment of deucravacitinib

Arms & Interventions

Participants treated with deucravacitinib

Adults with moderate plaque psoriasis who are newly initiating deucravacitinib according to the product label

Intervention: Deucravacitinib

Outcomes

Primary Outcomes

Number of participants achieving Static Physician's Global Assessment (sPGA) 0/1 score

Time Frame: Week 16

Number of participants achieving absolute Psoriasis Area and Severity Index (PASI) score ≤ 3

Time Frame: Week 16

Participant psoriasis Body Surface Area (BSA) involvement

Time Frame: Week 16

Secondary Outcomes

Number of participants achieving Psoriasis Area and Severity Index (PASI) 75 response and PASI 90 response(Baseline and Weeks 4, 12, 24, 36, and 52)
Static Physician's Global Assessment (sPGA) 0/1 response at follow-up(Weeks 4, 12, 24, 36, and 52)
Participants change in Static Physician's Global Assessment (sPGA) score from baseline(Baseline and Weeks 4, 12, 16, 24, 36, and 52)
Number of participants achieving a Dermatology Life Quality Index (DLQI) 0/1 score(Baseline and Weeks 4, 12, 16, 24, 36, and 52)
Number of participants achieving absolute Psoriasis Area and Severity Index (PASI) score ≤1, ≤2, ≤3, and ≤5(Baseline and Weeks 4, 12, 24, 36, and 52)
Number of participants achieving psoriasis Body Surface Area (BSA) involvement of ≤1% and ≤3%(Baseline and Weeks 4, 12, 16, 24, 36, and 52)
Change in Body Surface Area (BSA) involvement from baseline to follow-up(Weeks 4, 12, 24, 36, and 52)
Number of participants achieving a Dermatology Life Quality Index (DLQI) ≤ 3 score(Baseline and Weeks 4, 12, 16, 24, 36, and 52)
Participants change in Participant Absolute Psoriasis Area and Severity Index (PASI) score from baseline(Weeks 4, 12, 16, 24, 36, and 52)
Change in participant Dermatology Life Quality Index (DLQI) score from baseline(Baseline and Weeks 4, 12, 16, 24, 36, and 52)