Real-World Safety and Effectiveness of Sotyktu (Deucravacitinib) in Patients With Moderate-to-Severe Plaque Psoriasis in Korea
- Registration Number
- NCT06258668
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this observational study is to describe the safety and effectiveness of deucravacitinib in participants in Korea that have been diagnosed with moderate-to-severe plaque psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 505
Inclusion Criteria
- Adult participants ≥19 years of age
- Diagnosis of moderate-to-severe plaque psoriasis
- Candidate for phototherapy or systemic therapy
- Will begin deucravacitinib according to approved product label
Exclusion Criteria
- Participants prescribed deucravacitinib for therapeutic indications not approved in Korea
- Participants for whom deucravacitinib is contraindicated as clarified in Korean prescribing information by ministry of food and drug safety (MFDS)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants diagnosed with moderate-to-severe plaque psoriasis Deucravacitinib -
- Primary Outcome Measures
Name Time Method Number of participants with adverse drug reactions (ADRs) Up to 24 weeks from treatment initiation Number of participants with serious adverse events (SAEs) Up to 24 weeks from treatment initiation Number of participants with unexpected adverse events (AEs) Up to 24 weeks from treatment initiation Number of participants with unexpected serious adverse events (SAEs) Up to 24 weeks from treatment initiation Number of participants with adverse events (AEs) Up to 24 weeks from treatment initiation Number of participants with serious adverse drug reactions (SADRs) Up to 24 weeks from treatment initiation Number of participants with unexpected adverse drug reactions (ADRs) Up to 24 weeks from treatment initiation Number of participants with unexpected serious adverse drug reactions (SADRs) Up to 24 weeks from treatment initiation
- Secondary Outcome Measures
Name Time Method Proportion of participants with static Physician Global Assessment (sPGA) of 0 or 1 At Week 16 and/or Week 24 post treatment initiation Number of participants achieving Psoriasis Area and Severity Index (PASI) 75 (at least a 75% improvement in PASI score from baseline) At Week 16 and/or Week 24 post treatment initiation
Trial Locations
- Locations (2)
Local Institution - 0001
🇰🇷Seoul, Korea, Republic of
Novotech Laboratory Korea Co., Ltd.
🇰🇷Seoul, Korea, Republic of