Moderate-to-severe Plaque Psoriasis Clinical Trial
Official title:
Sotyktu (Deucravacitinib) Post-Marketing Surveillance in Korean Patients With Moderate-to-Severe Plaque Psoriasis
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.
| Status | Not yet recruiting |
| Enrollment | 505 |
| Est. completion date | December 1, 2028 |
| Est. primary completion date | November 1, 2028 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Bristol-Myers Squibb Pharmaceutical Korea Ltd | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with adverse events (AEs) | Up to 24 weeks from treatment initiation | ||
| Primary | Number of participants with adverse drug reactions (ADRs) | Up to 24 weeks from treatment initiation | ||
| Primary | Number of participants with serious adverse events (SAEs) | Up to 24 weeks from treatment initiation | ||
| Primary | Number of participants with serious adverse drug reactions (SADRs) | Up to 24 weeks from treatment initiation | ||
| Primary | Number of participants with unexpected adverse events (AEs) | Up to 24 weeks from treatment initiation | ||
| Primary | Number of participants with unexpected adverse drug reactions (ADRs) | Up to 24 weeks from treatment initiation | ||
| Primary | Number of participants with unexpected serious adverse events (SAEs) | Up to 24 weeks from treatment initiation | ||
| Primary | Number of participants with unexpected serious adverse drug reactions (SADRs) | Up to 24 weeks from treatment initiation | ||
| Secondary | Proportion of participants with static Physician Global Assessment (sPGA) of 0 or 1 | At Week 16 and/or Week 24 post treatment initiation | ||
| Secondary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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