Moderate-to-severe Plaque Psoriasis
Conditions
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.
Interventions
DRUGDeucravacitinib
As per product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with unexpected serious adverse drug reactions (SADRs) | 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 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Proportion of participants with static Physician Global Assessment (sPGA) of 0 or 1 | At Week 16 and/or Week 24 post treatment initiation |
Countries
South Korea
Contacts
Primary ContactBMS Study Connect Contact Center www.BMSStudyConnect.com
Backup ContactFirst line of the email MUST contain NCT # and Site #.
Outcome results
None listed