Clinical trial NCT06258668: Real-World Safety and Effectiveness of Sotyktu (Deucravacitinib) in Patients With Moderate-to-Severe Plaque Psoriasis in Korea
Official title: Sotyktu (Deucravacitinib) Post-Marketing Surveillance in Korean Patients With Moderate-to-Severe Plaque Psoriasis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Moderate-to-severe Plaque Psoriasis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-02-14
Enrollment: 505
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adult patients in Korea who have been diagnosed with moderate-to-severe plaque psoriasis and have been prescribed treatment with deucravacitinib according to the approved product label.

Brief 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 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)

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 24 weeks from treatment initiation
measure: Number of participants with adverse drug reactions (ADRs)
timeFrame: Up to 24 weeks from treatment initiation
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 24 weeks from treatment initiation
measure: Number of participants with serious adverse drug reactions (SADRs)
timeFrame: Up to 24 weeks from treatment initiation
measure: Number of participants with unexpected adverse events (AEs)
timeFrame: Up to 24 weeks from treatment initiation
measure: Number of participants with unexpected adverse drug reactions (ADRs)
timeFrame: Up to 24 weeks from treatment initiation
measure: Number of participants with unexpected serious adverse events (SAEs)
timeFrame: Up to 24 weeks from treatment initiation
measure: Number of participants with unexpected serious adverse drug reactions (SADRs)
timeFrame: Up to 24 weeks from treatment initiation
Secondary outcomes:
measure: Proportion of participants with static Physician Global Assessment (sPGA) of 0 or 1
timeFrame: At Week 16 and/or Week 24 post treatment initiation
measure: Number of participants achieving Psoriasis Area and Severity Index (PASI) 75 (at least a 75% improvement in PASI score from baseline)
timeFrame: At Week 16 and/or Week 24 post treatment initiation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0001
city: Seoul
country: Korea, Republic of
facility: Novotech Laboratory Korea Co., Ltd.
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: