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

NCT06258668 · Bristol-Myers Squibb

Recruiting

In plain English

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Official title

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

About this study

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 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)

Study design

Enrollment target: 505 participants

Age groups: adult, older_adult

Timeline

Starts: 2024-08-21

Estimated completion: 2028-09-30

Last updated: 2024-11-06

Interventions

Drug: Deucravacitinib

Primary outcomes

• 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)

Sponsor

Bristol-Myers Squibb · industry

Contacts & investigators

ContactBMS Study Connect Contact Center www.BMSStudyConnect.com · contact · Clinical.Trials@bms.com · 855-907-3286

ContactFirst line of the email MUST contain NCT # and Site #. · contact

InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb

All locations (2)

Local Institution - 0001Withdrawn

Seoul, South Korea

Novotech Laboratory Korea Co., Ltd.Recruiting

Seoul, South Korea

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