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

Launched by BRISTOL-MYERS SQUIBB · Aug 23, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus," is looking to understand how safe and effective a new medication called BMS-986326 is for people with lupus. The study involves giving participants different doses of the medication either through an IV (a small tube in the vein) or as an injection under the skin. Researchers want to see how the drug affects the body and its organs over time.

To participate in this trial, individuals need to have a form of lupus, such as Discoid Lupus Erythematosus (DLE), Subacute Cutaneous Lupus Erythematosus (SCLE), or Systemic Lupus Erythematosus (SLE). Participants should have a confirmed diagnosis and some ongoing symptoms. However, those with severe lupus, certain drug-induced forms of lupus, or those who are pregnant or breastfeeding, cannot join. While in the study, participants will receive the medication and will be monitored for any side effects and changes in their condition. This research is important as it may lead to new treatments for lupus, helping many who live with this condition.

Gender

ALL

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.