Menu
Recruiting NCT06258668

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

— Observational Moderate-to-severe Plaque Psoriasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deucravacitinib.
Who it may be relevant to
Registry conditions: Moderate-to-severe Plaque Psoriasis. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Sotyktu (Deucravacitinib) Post-Marketing Surveillance in Korean Patients With Moderate-to-Severe Plaque Psoriasis

Overview

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.

Interventions

  • Drug Deucravacitinib
    As per product label

Primary outcome measures

  • Number of participants with adverse events (AEs) [Time frame: Up to 24 weeks from treatment initiation]
  • Number of participants with adverse drug reactions (ADRs) [Time frame: Up to 24 weeks from treatment initiation]
  • Number of participants with serious adverse events (SAEs) [Time frame: Up to 24 weeks from treatment initiation]
  • Number of participants with serious adverse drug reactions (SADRs) [Time frame: Up to 24 weeks from treatment initiation]
  • Number of participants with unexpected adverse events (AEs) [Time frame: Up to 24 weeks from treatment initiation]
  • Number of participants with unexpected adverse drug reactions (ADRs) [Time frame: Up to 24 weeks from treatment initiation]
  • Number of participants with unexpected serious adverse events (SAEs) [Time frame: Up to 24 weeks from treatment initiation]
  • Number of participants with unexpected serious adverse drug reactions (SADRs) [Time frame: Up to 24 weeks from treatment initiation]
Secondary outcome measures (2)
  • Proportion of participants with static Physician Global Assessment (sPGA) of 0 or 1 [Time frame: 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) [Time frame: At Week 16 and/or Week 24 post treatment initiation]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

South Korea · 2 centers
  • Local Institution - 0001 — Seoul
  • Novotech Laboratory Korea Co., Ltd. — Seoul

Identifiers

NCT: NCT06258668 · IM011-1122

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗