A Observational Study to Evaluate Deucravacitinib in Patients With Moderate Plaque Psoriasis in China

Recruiting

• Conditions: Plaque Psoriasis
• Interventions: Drug: Deucravacitinib

• Registration Number: NCT06512337
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-22
• Status Verified: 2025-01
• Study Start: 2025-01-20
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants treated with deucravacitinib	Deucravacitinib	Adults with moderate plaque psoriasis who are newly initiating deucravacitinib according to the product label

Primary Outcome Measures

Name	Time	Method
Number of participants achieving Static Physician's Global Assessment (sPGA) 0/1 score	Week 16
Number of participants achieving absolute Psoriasis Area and Severity Index (PASI) score ≤ 3	Week 16
Participant psoriasis Body Surface Area (BSA) involvement	Week 16

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dermatology Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China