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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
Sponsor: Bristol-Myers Squibb
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.
Official title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986326 in Adult Participants With Discoid Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus, or Systemic Lupus Erythematosus
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2023-09-21
Completion Date
2026-04-08
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
BMS-986326
Specified dose on specified days
Placebo for BMS-986326
Specified dose on specified days
Locations (27)
Local Institution - 0048
San Diego, California, United States
Local Institution - 0055
Clearwater, Florida, United States
Local Institution - 0029
Tampa, Florida, United States
North Georgia Rheumatology
Lawrenceville, Georgia, United States
Skin Sciences
Louisville, Kentucky, United States
Local Institution - 0062
Las Vegas, Nevada, United States
Columbia University Irving Medical Center
New York, New York, United States
Local Institution - 0005
Duncansville, Pennsylvania, United States
Allen Arthritis
Allen, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Arthritis Northwest, PLLC
Spokane, Washington, United States
Hospital Universitario Austral
Pilar, Buenos Aires, Argentina
Clinica Adventista Belgrano
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 - 0073
Cuauhtémoc, Ciudad de México, DIF, Mexico
Local Institution - 0068
Mexico City, DIF, Mexico
Local Institution - 0077
Chihuahua City, Mexico
Local Institution - 0051
Leiden, Netherlands
Local Institution - 0074
Poznan, Poland
Local Institution - 0069
Warsaw, Poland
Local Institution - 0065
Bucharest, București, Romania
Local Institution - 0064
Cluj-Napoca, Cluj, Romania
Local Institution - 0046
A Coruña, A Coruña [La Coruña], Spain
Local Institution - 0045
Córdoba, Córdoba, Spain