Evaluating the safety and effectiveness of Sotyktu for plaque psoriasis in Korea
Official title: Sotyktu (Deucravacitinib) Post-Marketing Surveillance in Korean Patients With Moderate-to-Severe Plaque Psoriasis
Run by Bristol-Myers Squibb · NCT06258668 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 505 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | deucravacitinib |
| Locations | 2 sites (Seoul and 1 other locations) |
| Status | Recruiting |
| Started | August 21, 2024 |
| Main results expected | September 30, 2028 |
| Study ends | September 30, 2028 |
| Registry record updated | November 6, 2024 |
| Trial ID | NCT06258668 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Novotech Laboratory Korea Co., Ltd.
Seoul, South Korea Recruiting -
Local Institution - 0001
Seoul, South Korea Withdrawn
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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HS-20137: a treatment option for adults with moderate-to-severe plaque psoriasis
A phase 2 open-label study tests HS-20137 given as 200 mg at weeks 0, 4 and 8 to see if it is safe and helps patients with moderate-to-severe plaque psoriasis.
-
WD-890 in adults with moderate to severe plaque psoriasis
This study tests whether WD-890 tablets work better than a placebo for adults with moderate to severe plaque psoriasis.
-
Deucravacitinib for scarring hair loss (frontal fibrosing and central centrifugal alopecia)
This trial will test whether taking deucravacitinib once daily for 48 weeks helps adults with frontal fibrosing alopecia or central centrifugal cicatricial alopecia.
-
Deucravacitinib added to current PsA treatment for difficult-to-control disease
This study tests whether adding deucravacitinib to a patient’s existing Psoriatic Arthritis treatment can improve symptoms and quality of life for adults with hard-to-control disease.
-
TYK2 inhibitor for adults with moderate to severe plaque psoriasis
This will test whether a TYK2 inhibitor taken for 12 weeks helps adults with moderate to severe plaque psoriasis improve their skin and symptoms.
-
Long-term safety of deucravacitinib versus ustekinumab for plaque psoriasis (PRAGMATYK)
This study will test whether deucravacitinib or ustekinumab has better long-term safety for adults with moderate-to-severe plaque psoriasis who have cardiovascular risk factors.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.