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

RECRUITINGPhase 1Sponsored by Bristol-Myers Squibb
Actively Recruiting
PhasePhase 1
SponsorBristol-Myers Squibb
Started2023-09-21
Est. completion2026-04-12
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
Locations11 sites

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

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
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.

Conditions1

Lupus

Locations11 sites

Local Institution - 0048
San Diego, California, 92108
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, 33765
Robert Levin, Site 0055727-466-0078
Clinical Research of West Florida
Tampa, Florida, 33606
John Carter, Site 0029813-870-1292
North Georgia Rheumatology
Lawrenceville, Georgia, 30046
Skin Sciences
Louisville, Kentucky, 40217
Leon Kircik, Site 0061502-451-9000

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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