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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
NCT06013995 · Bristol-Myers Squibb
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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 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.
Study design
Enrollment target: 44 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2023-09-21
Estimated completion: 2026-04-08
Last updated: 2026-04-01
Interventions
Drug: BMS-986326Other: Placebo for BMS-986326
Primary outcomes
- • Number of participants with adverse events (AEs) (Up to 228 days)
- • Number of participants with serious adverse events (SAEs) (Up to 228 days)
- • Number of participants with clinical laboratory abnormalities (Up to 228 days)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (27)
Local Institution - 0048Completed
San Diego, California, United States
Local Institution - 0055Completed
Clearwater, Florida, United States
Local Institution - 0029Completed
Tampa, Florida, United States
North Georgia RheumatologyWithdrawn
Lawrenceville, Georgia, United States
Skin SciencesRecruiting
Louisville, Kentucky, United States
Local Institution - 0062Completed
Las Vegas, Nevada, United States
Columbia University Irving Medical CenterWithdrawn
New York, New York, United States
Local Institution - 0005Completed
Duncansville, Pennsylvania, United States
Allen ArthritisWithdrawn
Allen, Texas, United States
Metroplex Clinical Research CenterWithdrawn
Dallas, Texas, United States
Arthritis Northwest, PLLCRecruiting
Spokane, Washington, United States
Hospital Universitario AustralRecruiting
Pilar, Buenos Aires, Argentina
Clinica Adventista BelgranoRecruiting
CABA, Buenos Aires F.D., Argentina
Local Institution - 0072Active Not Recruiting
Sofia, Bulgaria
Local Institution - 0044Completed
Berlin, Germany
Local Institution - 0071Completed
Dessau, Germany
Local Institution - 0047Completed
Dresden, Germany
Local Institution - 0073Withdrawn
Cuauhtémoc, Ciudad de México, DIF, Mexico
Local Institution - 0068Withdrawn
Mexico City, DIF, Mexico
Local Institution - 0077Withdrawn
Chihuahua City, Mexico
Local Institution - 0051Completed
Leiden, Netherlands
Local Institution - 0074Active Not Recruiting
Poznan, Poland
Local Institution - 0069Completed
Warsaw, Poland
Local Institution - 0065Completed
Bucharest, Bucharest, Romania
Local Institution - 0064Active Not Recruiting
Cluj-Napoca, Cluj, Romania
Local Institution - 0046Completed
A Coruña, A Coruña [La Coruña], Spain
Local Institution - 0045Completed
Córdoba, Córdoba, Spain