PsoriasisNCT06952465
A Study Comparing the Risk of Serious Infections and Malignancies With Deucravacitinib or Biologics in Japanese Patients With Psoriasis
An observational study of Psoriasis, run by Bristol-Myers Squibb at 2 sites in Japan.
Trial summary
The purpose of this study is to further evaluate the safety of deucravacitinib treatment in Japanese patients with psoriasis in the real-world setting Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Deucravacitinib and Any biologic treatment for psoriasis
- How many people
- 2,000 participants
- Where
- 2 sitesJapan
- Study dates
- 24 Jan 2025to 30 Nov 2031
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include adult patients identified from the Japanese healthcare claims database with psoriasis who have initiated either deucravacitinib or any biologic treatment for psoriasis
Who may be able to join
- Participants with prescriptions in deucravacitinib or any biologics as comparator group during the indexing period.
- Participants with at least one confirmed diagnosis of disease code for psoriasis within 12 months prior to the index date.
- Aged 18 years or older at the index date
Who cannot join
- Participants with prescription in deucravacitinib or any biologics as comparator group prior to the index date.
- Participants with fewer than 12 months of available claim records prior to the index date.
- Participants with no claims record within 1-year after the index date (no visit after the index date).
- Specific for serious infection: Participants who had at least one disease code of hospitalized infection in the 60 days period before the index date.
- Specific for malignancy: Participants who had at least one disease code of malignancy prior to the index date
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Cohort Study Comparing the Risk of Serious Infections and Malignancies With Deucravacitinib or Biologics in Japanese Patients With Plaque Psoriasis, Generalized Pustular Psoriasis, and Erythrodermic Psoriasis Using Administrative Health Claims Database
The purpose of this study is to further evaluate the safety of deucravacitinib treatment in Japanese patients with psoriasis in the real-world setting
- Conditions
- Psoriasis
- Being tested
- Deucravacitinib, Any biologic treatment for psoriasis
- Keywords
- Psoriasis (PsO)
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucravacitinibDrug
As per product label
Any biologic treatment for psoriasisBiological
According to the product label
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants receiving deucravacitinib treatment Receives: Drug: Deucravacitinib | |
| Cohort 2 | Participants receiving biologics treatment for psoriasis Receives: Biological: Any biologic treatment for psoriasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant baseline demographics
Measured: Baseline
Participant medical history
Measured: Baseline
Incidence of serious infections
Measured: Up to 9-years
Incidence of malignancies
Measured: Up to 9-years
Secondary outcomes (10)
Incidence of serious infections excluding COVID-19
Measured: Up to 9-years
Incidence of serious infection of COVID-19
Measured: Up to 9-years
Incidence of opportunistic infections excluding tuberculosis and herpes zoster
Measured: Up to 9-years
Incidence of tuberculosis
Measured: Up to 9-years
Incidence of herpes zoster
Measured: Up to 9-years
Incidence of malignancies excluding non-melanoma skin cancer
Measured: Up to 9-years
Incidence of non-melanoma skin cancer
Measured: Up to 9-years
Incidence of solid tumors
Measured: Up to 9-years
Incidence of hematologic malignancies
Measured: Up to 9-years
Incidence of lymphoma
Measured: Up to 9-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start24 Jan 2025
- Primary completion30 Nov 2031 (estimated)
- Study completion30 Nov 2031 (estimated)
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
- Retrospective
- Enrolment
- 2,000 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
- NCT06952465
- Sponsor's protocol ID
- IM011-227
- Status last verified
- Sep 2026
- First submitted
- 29 Apr 2025
- Last updated
- 1 Oct 2026
- 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study Comparing the Risk of Serious Infections and Malignancies With Deucravacitinib or Biologics in Japanese Patients With Plaque Psoriasis, Generalized Pustular Psoriasis, and Erythrodermic Psoriasis Using Administrative Health Claims Database
- ClinicalTrials.gov ID
- NCT06952465
- Acronym / sponsor ID
- IM011-227
- Conditions
- Psoriasis
- Keywords
- Psoriasis (PsO)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 30 Nov 2031 (estimated)
- Study completion
- 30 Nov 2031 (estimated)
- First posted
- 1 May 2025 (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 further evaluate the safety of deucravacitinib treatment in Japanese patients with psoriasis in the real-world setting
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: DeucravacitinibParticipants receiving deucravacitinib treatment |
| Cohort 2 | – | Biological: Any biologic treatment for psoriasisParticipants receiving biologics treatment for psoriasis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adult patients identified from the Japanese healthcare claims database with psoriasis who have initiated either deucravacitinib or any biologic treatment for psoriasis
Key inclusion criteria (3 listed)
- Participants with prescriptions in deucravacitinib or any biologics as comparator group during the indexing period.
- Participants with at least one confirmed diagnosis of disease code for psoriasis within 12 months prior to the index date.
- Aged 18 years or older at the index date
Key exclusion criteria (5 listed)
- Participants with prescription in deucravacitinib or any biologics as comparator group prior to the index date.
- Participants with fewer than 12 months of available claim records prior to the index date.
- Participants with no claims record within 1-year after the index date (no visit after the index date).
- Specific for serious infection: Participants who had at least one disease code of hospitalized infection in the 60 days period before the index date.
- Specific for malignancy: Participants who had at least one disease code of malignancy prior to the index date
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 | Cohort 1 |
| Any biologic treatment for psoriasisAccording to the product label | Biological | Cohort 2 |
Primary outcome
Participant baseline demographics
Time frame: Baseline
Participant medical history
Time frame: Baseline
Incidence of serious infections
Time frame: Up to 9-years
Incidence of malignancies
Time frame: Up to 9-years
10 secondary outcomes
Incidence of serious infections excluding COVID-19
Time frame: Up to 9-years
Incidence of serious infection of COVID-19
Time frame: Up to 9-years
Incidence of opportunistic infections excluding tuberculosis and herpes zoster
Time frame: Up to 9-years
Incidence of tuberculosis
Time frame: Up to 9-years
Incidence of herpes zoster
Time frame: Up to 9-years
Incidence of malignancies excluding non-melanoma skin cancer
Time frame: Up to 9-years
Incidence of non-melanoma skin cancer
Time frame: Up to 9-years
Incidence of solid tumors
Time frame: Up to 9-years
Incidence of hematologic malignancies
Time frame: Up to 9-years
Incidence of lymphoma
Time frame: Up to 9-years
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 1 Oct 2026.
- 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. This study is not recruiting at the moment.
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 Psoriasis, run by Bristol-Myers Squibb at 2 sites 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. 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 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?
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?
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?
Participant baseline demographics (time frame: Baseline). The study lists 4 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 1 Oct 2026.