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Investigating the effects of BMS-986326 in adults with different forms of lupus

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

Phase 1 Interventional Bristol-Myers Squibb · NCT06013995

This study is testing a new drug called BMS-986326 to see if it is safe and effective for adults with different types of lupus.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment44 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionsprednisone
Locations27 sites (San Diego, California and 26 other locations)
Trial IDNCT06013995 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and pharmacokinetics of BMS-986326 in adult participants diagnosed with various forms of lupus, including Discoid Lupus Erythematosus (DLE) and Subacute Cutaneous Lupus Erythematosus (SCLE). Participants will receive multiple increasing doses of the drug through intravenous infusion or subcutaneous injection. The study aims to assess drug levels and effects on cells and organs, providing critical data on its therapeutic potential for lupus patients.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with DLE, SCLE, or mild to moderate Systemic Lupus Erythematosus (SLE).

Not a fit: Patients with severe SLE or those with drug-induced lupus are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for patients suffering from different forms of lupus.

How similar studies have performed: Other studies have shown promise with similar pharmacological approaches in treating lupus, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

San Diego, California and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions LupusPharmacokineticsBMS-986326Cutaneous Lupusdiscoid lupus erythematosussubacute cutaneous lupus erythematosusSystemic lupus erythematosus
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.