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Clinical Trials in South Korea / NCT06258668
Recruiting Observational

Real-World Safety and Effectiveness of Sotyktu (Deucravacitinib) in Patients With Moderate-to-Severe Plaque Psoriasis in Korea

NCT06258668 · tracked via the Priya Life Science South Korea tracker
Sponsor
Bristol-Myers Squibb
Phase
Observational
Started
2024-08-21
Last updated
2024-11-06

Condition(s) studied

Moderate-to-severe Plaque Psoriasis

Investigational drug(s) / intervention(s)

Deucravacitinib →

Deucravacitinib: As per product label

Study 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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Number of participants with adverse events (AEs) — Up to 24 weeks from treatment initiation
  • 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 serious adverse drug reactions (SADRs) — 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 adverse drug reactions (ADRs) — 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 unexpected serious adverse drug reactions (SADRs) — Up to 24 weeks from treatment initiation

Trial sites (2)

FacilityCityRegionStatus
Local Institution - 0001 Seoul South Korea Withdrawn
Novotech Laboratory Korea Co., Ltd. Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06258668 on ClinicalTrials.gov ↗ ← All trials in South Korea