Continued deucravacitinib treatment for people with systemic or cutaneous lupus who completed earlier trials
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
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 |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | deucravacitinib |
| Locations | 4 sites (Farmington, Connecticut and 3 other locations) |
| Trial ID | NCT06875960 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Farmington, Connecticut and 3 other locations
- Local Institution - 0001 — Farmington, Connecticut, United States (Withdrawn)
- 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 - 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.