Evaluating the safety and effectiveness of Sotyktu for plaque psoriasis in Korea
Sotyktu (Deucravacitinib) Post-Marketing Surveillance in Korean Patients With Moderate-to-Severe Plaque Psoriasis
This study is testing if a new medication called Sotyktu is safe and effective for adults in Korea with moderate-to-severe plaque psoriasis who need treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 505 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | deucravacitinib |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT06258668 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and effectiveness of deucravacitinib, also known as Sotyktu, in adult patients diagnosed with moderate-to-severe plaque psoriasis in Korea. Participants will be those who are candidates for phototherapy or systemic therapy and will begin treatment with deucravacitinib as per the approved product label. The study will collect real-world data to better understand the outcomes associated with this treatment in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older with a diagnosis of moderate-to-severe plaque psoriasis who are eligible for phototherapy or systemic therapy.
Not a fit: Patients who are prescribed deucravacitinib for unapproved therapeutic indications or those for whom the drug is contraindicated will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of Sotyktu for patients with moderate-to-severe plaque psoriasis.
How similar studies have performed: Other studies evaluating the safety and effectiveness of similar treatments for plaque psoriasis have shown promising results, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Seoul and 1 other locations
- Local Institution - 0001 — Seoul, South Korea (Withdrawn)
- Novotech Laboratory Korea Co., Ltd. — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.