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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
View on ClinicalTrials.gov →
NCT06013995
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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Actively Recruiting
PhasePhase 1
SponsorBristol-Myers Squibb
Started2023-09-21
Est. completion2026-04-12
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
Locations11 sites
View on ClinicalTrials.gov →
NCT06013995