Systemic Lupus ErythematosusPhase 3NCT07791199
Continued Access to Deucravacitinib for Adult SLE/SjD and Pediatric PsO/PsA Study Completers
A Phase 3 study testing Deucravacitinib in people with Systemic Lupus Erythematosus and Sjögren's Disease, run by Bristol-Myers Squibb.
Trial summary
This study is designed to provide treatment with deucravacitinib for participants with SLE/SjD (Systemic Lupus Erythematosus/Sjögren's Disease) and pediatric participants with PsO/PsA (Psoriasis/Psoriatic Arthritis) who have completed their qualified parent studies and/or long-term extension if applicable. Read more about this study
- Who is it for?
- Ages 4 to 75 years
- Conditions the study is for
- Systemic Lupus Erythematosus, Sjögren's Disease, Psoriasis
- What is being tested?
- Deucravacitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,300 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2026to 31 Oct 2030
- Phase
- Phase 3
- 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 4 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must have completed qualifying parent study through the protocol required treatment period. Qualifying studies include IM011-246, IM011-247, IM011-1069, IM011-126, IM011-1128, and IM011-1071.
Who cannot join
- Participants must not have any disease or medical condition that, in the opinion of the physician, would make them unsuitable for this protocol, would interfere with the interpretation of their safety or considered unsuitable by the physician for any other reason.
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
About this study
Official title: A Continuation Protocol for Deucravacitinib in Adult Patients With Systemic Lupus Erythematosus (SLE) or Sjögren's Disease (SjD) and Pediatric Patients With Psoriasis (PsO) or Psoriatic Arthritis (PsA) Who Have Completed Parent Studies
This study is designed to provide treatment with deucravacitinib for participants with SLE/SjD (Systemic Lupus Erythematosus/Sjögren's Disease) and pediatric participants with PsO/PsA (Psoriasis/Psoriatic Arthritis) who have completed their qualified parent studies and/or long-term extension if applicable.
- Being tested
- Deucravacitinib
- Keywords
- SLE, SJD, SJS, PSO, PSA, POETYK, POETYK-1, POETYK-2, POETK-SJS, jPSA, Pediatric, Juvenile, Deucravacitinib, SOTYKTU
- Medical subject headings
- Lupus Erythematosus, Systemic, Sjogren's Syndrome, Psoriasis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucravacitinibDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Deucravacitinib Arm | Experimental | 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 treated
Measured: Up to approximately 28 days after last dose of deucravacitinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start31 Dec 2026 (estimated)
- Primary completion31 Oct 2030 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,300 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
- NCT07791199
- Sponsor's protocol ID
- IM011-1341
- Other IDs
- 2026-527576-84
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Continuation Protocol for Deucravacitinib in Adult Patients With Systemic Lupus Erythematosus (SLE) or Sjögren's Disease (SjD) and Pediatric Patients With Psoriasis (PsO) or Psoriatic Arthritis (PsA) Who Have Completed Parent Studies
- ClinicalTrials.gov ID
- NCT07791199
- Acronym / sponsor ID
- IM011-1341
- Keywords
- SLE, SJD, SJS, PSO, PSA, POETYK, POETYK-1, POETYK-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 31 Oct 2030 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 27 Aug 2026 (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.
This study is designed to provide treatment with deucravacitinib for participants with SLE/SjD (Systemic Lupus Erythematosus/Sjögren's Disease) and pediatric participants with PsO/PsA (Psoriasis/Psoriatic Arthritis) who have completed their qualified parent studies and/or long-term extension if applicable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deucravacitinib Arm | Experimental | Drug: Deucravacitinib |
Who may qualify
- Ages
- 4 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must have completed qualifying parent study through the protocol required treatment period. Qualifying studies include IM011-246, IM011-247, IM011-1069, IM011-126, IM011-1128, and IM011-1071.
Key exclusion criteria (2 listed)
- Participants must not have any disease or medical condition that, in the opinion of the physician, would make them unsuitable for this protocol, would interfere with the interpretation of their safety or considered unsuitable by the physician for any other reason.
- Other protocol-defined inclusion/exclusion criteria apply.
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 |
|---|---|---|
| DeucravacitinibSpecified dose on specified days | Drug | Deucravacitinib Arm |
Primary outcome
Number of participants treated
Time frame: Up to approximately 28 days after last dose of deucravacitinib
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 3 Sep 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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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.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Deucravacitinib in people with Systemic Lupus Erythematosus and Sjögren's Disease, run by Bristol-Myers Squibb.
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 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: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Clinical Trials Contact Center www.BMSClinicalTrials.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 treated (time frame: Up to approximately 28 days after last dose of deucravacitinib). 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 Sep 2026.