PsoriasisNCT05633264
A Study to Assess Deucravacitinib Post-marketing Surveillance in Participants With Psoriasis in Japan
An observational study of Psoriasis, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
The purpose of this study is to determine the safety and effectiveness of deucravacitinib for the treatment of plaque psoriasis (PsO) in Japan participants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psoriasis
- How many people
- 369 participants
- Where
- 1 siteJapan
- Study dates
- 5 Dec 2022to 28 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of Psoriasis (PsO) participants (participants with plaque psoriasis, generalized pustular psoriasis, and erythrodermic psoriasis) who initiate treatment with Deucravacitinib will be enrolled. Participants receiving Deucravacitinib for an off label indication will be excluded.
Who may be able to join
- Psoriasis (PsO) participants who received Deucravacitinib for the first time of the approved indications at medical institutions in Japan will be enrolled in this PMS
Who cannot join
- Participants receiving Deucravacitinib for an off-label indication will be excluded from this PMS.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deucravacitinib Post-marketing Surveillance in Patients With Psoriasis in Japan
The purpose of this study is to determine the safety and effectiveness of deucravacitinib for the treatment of plaque psoriasis (PsO) in Japan participants.
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Deucravacitinib
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Psoriasis (PsO) participants who initiate treatment with Deucravacitinib. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Measured: Up to 52 weeks
Secondary outcomes (8)
Proportion of participants achieving Static Physicians Global Assessment (sPGA) of 0/1 during study period
Measured: Up to 52 weeks
Change from Baseline in Body Surface Area (BSA) during study period
Measured: Up to 52 weeks
Proportion of participants achieving Global Improvement Score (GIS) during study period
Measured: Up to 52 weeks
Distribution of demographic characteristics: Age
Measured: Up to 52 weeks
Distribution of demographic characteristics: Sex
Measured: Up to 52 weeks
Distribution of demographic characteristics: Height
Measured: Up to 52 weeks
Distribution of demographic characteristics: Weight
Measured: Up to 52 weeks
Distribution of demographic characteristics: Past history /complication
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start5 Dec 2022
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 369 participants (actual)
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
- NCT05633264
- Sponsor's protocol ID
- IM011-226
- Status last verified
- Jul 2025
- First submitted
- 22 Nov 2022
- Last updated
- 3 Jul 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deucravacitinib Post-marketing Surveillance in Patients With Psoriasis in Japan
- ClinicalTrials.gov ID
- NCT05633264
- Acronym / sponsor ID
- IM011-226
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Deucravacitinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 1 Dec 2022 (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 study is to determine the safety and effectiveness of deucravacitinib for the treatment of plaque psoriasis (PsO) in Japan participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Psoriasis (PsO) participants who initiate treatment with Deucravacitinib. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of Psoriasis (PsO) participants (participants with plaque psoriasis, generalized pustular psoriasis, and erythrodermic psoriasis) who initiate treatment with Deucravacitinib will be enrolled. Participants receiving Deucravacitinib for an off label indication will be excluded.
Key inclusion criteria (1 listed)
- Psoriasis (PsO) participants who received Deucravacitinib for the first time of the approved indications at medical institutions in Japan will be enrolled in this PMS
Key exclusion criteria (1 listed)
- Participants receiving Deucravacitinib for an off-label indication will be excluded from this PMS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Up to 52 weeks
8 secondary outcomes
Proportion of participants achieving Static Physicians Global Assessment (sPGA) of 0/1 during study period
Time frame: Up to 52 weeks
Change from Baseline in Body Surface Area (BSA) during study period
Time frame: Up to 52 weeks
Proportion of participants achieving Global Improvement Score (GIS) during study period
Time frame: Up to 52 weeks
Distribution of demographic characteristics: Age
Time frame: Up to 52 weeks
Distribution of demographic characteristics: Sex
Time frame: Up to 52 weeks
Distribution of demographic characteristics: Height
Time frame: Up to 52 weeks
Distribution of demographic characteristics: Weight
Time frame: Up to 52 weeks
Distribution of demographic characteristics: Past history /complication
Time frame: Up to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Bristol-Myers Squibb at 1 site in Japan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: Up to 52 weeks). 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 3 Jul 2025.