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
- Are there results?
- Not yet: the study is under way
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- Withdrawn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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sotyktu (Deucravacitinib) Post-Marketing Surveillance in Korean Patients With Moderate-to-Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT06258668
- Acronym / sponsor ID
- IM011-1122
- Conditions
- Moderate-to-severe Plaque Psoriasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 505 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants diagnosed with moderate-to-severe plaque psoriasis | – | Drug: Deucravacitinib |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeucravacitinibAs per product label | Drug | Participants diagnosed with moderate-to-severe plaque psoriasis |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to 24 weeks from treatment initiation
Number of participants with adverse drug reactions (ADRs)
Time frame: Up to 24 weeks from treatment initiation
Number of participants with serious adverse events (SAEs)
Time frame: Up to 24 weeks from treatment initiation
Number of participants with serious adverse drug reactions (SADRs)
Time frame: Up to 24 weeks from treatment initiation
Number of participants with unexpected adverse events (AEs)
Time frame: Up to 24 weeks from treatment initiation
Number of participants with unexpected adverse drug reactions (ADRs)
Time frame: Up to 24 weeks from treatment initiation
Number of participants with unexpected serious adverse events (SAEs)
Time frame: Up to 24 weeks from treatment initiation
Number of participants with unexpected serious adverse drug reactions (SADRs)
Time frame: Up to 24 weeks from treatment initiation
2 secondary outcomes
Proportion of participants with static Physician Global Assessment (sPGA) of 0 or 1
Time frame: 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)
Time frame: At Week 16 and/or Week 24 post treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate-to-severe Plaque Psoriasis, run by Bristol-Myers Squibb at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) (time frame: Up to 24 weeks from treatment initiation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.