A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus

Completed · Phase 1 · Has a placebo group

Conditions studied: Lupus

In brief

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 subcutaneous (SC) injection, in participants with different forms of lupus.

Key facts

Study ID

NCT06013995

Run by

Bristol-Myers Squibb

People needed

45

Starts

2023-09-21

Expected to finish

2026-04-14

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Local Institution - 0048 — San Diego, California, United States
• Local Institution - 0055 — Clearwater, Florida, United States
• Local Institution - 0029 — Tampa, Florida, United States
• Skin Sciences — Louisville, Kentucky, United States
• Local Institution - 0062 — Las Vegas, Nevada, United States
• Local Institution - 0005 — Duncansville, Pennsylvania, United States
• Arthritis Northwest, PLLC — Spokane, Washington, United States
• Local Institution - 0070 — Pilar, Buenos Aires, Argentina
• Local Institution - 0075 — CABA, Buenos Aires F.D., Argentina
• Local Institution - 0072 — Sofia, Bulgaria
• Local Institution - 0044 — Berlin, Germany
• Local Institution - 0071 — Dessau, Germany
• Local Institution - 0047 — Dresden, Germany
• Local Institution - 0051 — Leiden, Netherlands
• Local Institution - 0074 — Poznan, Poland
• Local Institution - 0069 — Warsaw, Poland
• Local Institution - 0065 — Bucharest, Bucharest, Romania
• Local Institution - 0064 — Cluj-Napoca, Cluj, Romania
• Local Institution - 0046 — A Coruña, A Coruña [La Coruña], Spain
• Local Institution - 0045 — Córdoba, Córdoba, Spain

Full record on ClinicalTrials.gov

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