Status:
RECRUITING
A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Lupus
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate safety, drug levels and drug effects on cells and organs of the body, after receiving multiple increasing doses of BMS-986326 via intravenous (IV) infusion or ...
Eligibility Criteria
Inclusion Criteria:
- Having a diagnosis of Discoid Lupus Erythematosus (DLE), Subacute Cutaneous Lupus Erythematosus (SCLE), or Systemic Lupus Erythematosus (SLE).
- Participants with DLE or SCLE must have their diagnosis at least 3 months prior to screening and must be confirmed by biopsy (except if only the facial/head/neck region is affected) and must have some ongoing disease activity (based CLASI-A scoring).
- Participants with SLE must have a diagnosis of SLE at screening based on the 2019 EULAR/ACR Classification for SLE and have mild-moderate disease severity (based on a SLEDAI-2K score).
Exclusion criteria:
- SLE that is considered by the Investigator to be severe.
- Drug-induced CLE and drug-induced SLE.
- Women who are pregnant or breastfeeding.
- Current use of >10 mg prednisone (or equivalent) per day.
Note: Other protocol-defined inclusion/exclusion criteria apply.
Key Trial Info
Start Date :
September 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 8 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06013995
Start Date
September 21 2023
End Date
April 8 2026
Last Update
April 1 2026
Active Locations (27)
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1
Local Institution - 0048
San Diego, California, United States, 92108
2
Local Institution - 0055
Clearwater, Florida, United States, 33765
3
Local Institution - 0029
Tampa, Florida, United States, 33606
4
North Georgia Rheumatology
Lawrenceville, Georgia, United States, 30046