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A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132
NCT06875960 · Bristol-Myers Squibb
In plain English
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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
About this study
The purpose of this study is to allow the continued administration of Deucravacitinib in participants with Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) who have completed study IM011074 or Study IM011132
Eligibility 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.
Study design
Enrollment target: 35 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-02-24
Estimated completion: 2026-12-01
Last updated: 2026-03-30
Interventions
Drug: BMS-986165
Primary outcomes
- • Number of participants treated with BMS-986165 (Up to 2 years)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (4)
Local Institution - 0001Withdrawn
Farmington, Connecticut, United States
New York University School Of MedicineRecruiting
New York, New York, United States
Oklahoma Medical Research FoundationRecruiting
Oklahoma City, Oklahoma, United States
Local Institution - 0003Withdrawn
Jackson, Tennessee, United States