Moderate-to-severe Plaque PsoriasisNCT06258668
Real-World Safety and Effectiveness of Sotyktu (Deucravacitinib) in Patients With Moderate-to-Severe Plaque Psoriasis in Korea
An observational study of Moderate-to-severe Plaque Psoriasis, run by Bristol-Myers Squibb at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Moderate-to-severe Plaque Psoriasis
- What is being tested?
- Deucravacitinib
- How many people
- 505 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 21 Aug 2024to 30 Sep 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
First line of the email MUST contain NCT # and Site #. contact
South Korea2 sites, 1 recruiting
- Withdrawn
Local Institution - 0001
Seoul, 06234
- Recruiting
Novotech Laboratory Korea Co., Ltd.
Seoul, 06234
South Korea Generic Country, Site 0002, 0000000000
About this study
Official title: Sotyktu (Deucravacitinib) Post-Marketing Surveillance in Korean Patients With Moderate-to-Severe Plaque Psoriasis
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.
- Conditions
- Moderate-to-severe Plaque Psoriasis
- Being tested
- Deucravacitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucravacitinibDrug
As per product label
| Study group | Role | What they receive |
|---|---|---|
| Participants diagnosed with moderate-to-severe plaque psoriasis | Not described Receives: Drug: Deucravacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Measured: Up to 24 weeks from treatment initiation
Number of participants with adverse drug reactions (ADRs)
Measured: Up to 24 weeks from treatment initiation
Number of participants with serious adverse events (SAEs)
Measured: Up to 24 weeks from treatment initiation
Number of participants with serious adverse drug reactions (SADRs)
Measured: Up to 24 weeks from treatment initiation
Number of participants with unexpected adverse events (AEs)
Measured: Up to 24 weeks from treatment initiation
Number of participants with unexpected adverse drug reactions (ADRs)
Measured: Up to 24 weeks from treatment initiation
Number of participants with unexpected serious adverse events (SAEs)
Measured: Up to 24 weeks from treatment initiation
Number of participants with unexpected serious adverse drug reactions (SADRs)
Measured: Up to 24 weeks from treatment initiation
Secondary outcomes (2)
Proportion of participants with static Physician Global Assessment (sPGA) of 0 or 1
Measured: At Week 16 and/or Week 24 post treatment initiation
Number of participants achieving Psoriasis Area and Severity Index (PASI) 75 (at least a 75% improvement in PASI score from baseline)
Measured: At Week 16 and/or Week 24 post treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start21 Aug 2024
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-to-severe Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 505 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258668
- Sponsor's protocol ID
- IM011-1122
- Status last verified
- Nov 2024
- First submitted
- 3 Feb 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No