Continued deucravacitinib treatment for people with systemic or cutaneous lupus who completed earlier trials
Official title: A Continuation Protocol for Deucravacitinib in Patients With Patients With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132
Run by Bristol-Myers Squibb · NCT06875960 · Data updated 2026-11-12
This open-label extension lets people with systemic lupus or discoid/subacute cutaneous lupus who finished specific earlier trials continue taking deucravacitinib to see if ongoing treatment remains safe and tolerable.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | deucravacitinib |
| Locations | 4 sites (Farmington, Connecticut and 3 other locations) |
| Status | Recruiting |
| Started | February 24, 2026 |
| Main results expected | January 31, 2028 |
| Study ends | January 31, 2028 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT06875960 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with SLE or DLE/SCLE who completed IM011074 or IM011132, received the investigational product recently, and whom their physician believes are likely to benefit from continued treatment.
✕Probably not a fit
People with active tuberculosis, other physician-determined contraindications, or who did not complete the prerequisite parent studies are unlikely to be eligible or receive benefit from this continuation protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants who completed Study IM011074 or IM011132 are invited to continue receiving deucravacitinib under physician supervision in an open-label format. Enrollment requires recent receipt of the investigational product (within 60 days) and physician judgement that the participant is likely to benefit. The protocol excludes people with active tuberculosis and other conditions that would make continued participation unsafe or confound safety interpretation. The main focus is long-term access to the drug and ongoing safety and tolerability monitoring rather than testing efficacy anew.
Why it matters
Potential benefit: If successful, participants may maintain clinical benefit from continued deucravacitinib and contribute to longer-term safety data.
How similar studies have gone: Deucravacitinib has shown clear efficacy in psoriasis and earlier controlled trials and extension studies have been used to collect longer-term safety and maintenance data in lupus populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * Participants must have completed Study IM011074 or Study IM011132 through the protocol-required treatment period. * Participants must be, based on the physician's medical judgement, likely to receive benefit from receiving treatment with deucravacitinib. * Participants must have received IP within 60 days of enrollment. Exceptions may be granted based upon consultation with BMS. Exclusion Criteria * Participants must not have any disease or medical condition that, in the opinion of the physician, would make the subject unsuitable for this protocol, would interfere with the interpretation of subject safety or considered unsuitable by the physician for any other reason. * Participants must not have any evidence of active Tuberculosis (TB). * Other protocol-defined Inclusion/Exclusion criteria apply.
Where it's running
-
New York University School Of Medicine
New York, New York, United States Recruiting -
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States Recruiting -
Local Institution - 0001
Farmington, Connecticut, United States Withdrawn -
Local Institution - 0003
Jackson, Tennessee, United States Withdrawn
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.