Real-World Safety and Effectiveness of Sotyktu (Deucravacitinib) in Patients With Moderate-to-Severe Plaque Psoriasis in Korea
Recruiting
- Conditions
- Moderate-to-severe Plaque Psoriasis
- Registration Number
- NCT06258668
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 505
Inclusion Criteria
Inclusion Criteria:<br><br> - Adult participants =19 years of age<br><br> - Diagnosis of moderate-to-severe plaque psoriasis<br><br> - Candidate for phototherapy or systemic therapy<br><br> - Will begin deucravacitinib according to approved product label<br><br>Exclusion Criteria:<br><br> - Participants prescribed deucravacitinib for therapeutic indications not approved in<br> Korea<br><br> - Participants for whom deucravacitinib is contraindicated as clarified in Korean<br> prescribing information by ministry of food and drug safety (MFDS)
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AEs);Number of participants with adverse drug reactions (ADRs);Number of participants with serious adverse events (SAEs);Number of participants with serious adverse drug reactions (SADRs);Number of participants with unexpected adverse events (AEs);Number of participants with unexpected adverse drug reactions (ADRs);Number of participants with unexpected serious adverse events (SAEs);Number of participants with unexpected serious adverse drug reactions (SADRs)
- Secondary Outcome Measures
Name Time Method Proportion of participants with static Physician Global Assessment (sPGA) of 0 or 1;Number of participants achieving Psoriasis Area and Severity Index (PASI) 75 (at least a 75% improvement in PASI score from baseline)