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New lupus drug candidate BMS-986326 enters early human testing

NCT ID NCT06013995

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested a new drug called BMS-986326 in 45 adults with different forms of lupus, including skin and systemic lupus. The main goal was to check safety and how the body processes the drug, not yet to see if it works. Participants received either the drug or a placebo through an IV or injection, and researchers monitored side effects and drug levels in the blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BMS-986326
What this could lead to
If this drug is safe and shows promise, it could point toward a new treatment option for lupus that helps control the disease.
What could go wrong
This is a very early, small phase 1 trial focused on safety, not effectiveness. The drug may not work or could have side effects. Many early-stage drugs fail to advance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

45 people

The number who actually took part.

Started

Sep 2023

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cutaneous lupus erythematosus discoid lupus erythematosus lupus erythematosus subacute cutaneous lupus erythematosus systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lupus

Contacts and locations

Locations

  • Arthritis Northwest, PLLC

    Spokane, Washington, 99204, United States

  • Local Institution - 0005

    Duncansville, Pennsylvania, 16635, United States

  • Local Institution - 0029

    Tampa, Florida, 33606, United States

  • Local Institution - 0044

    Berlin, 10117, Germany

  • Local Institution - 0045

    Córdoba, Córdoba, 14004, Spain

  • Local Institution - 0046

    A Coruña, A Coruña [La Coruña], 15006, Spain

  • Local Institution - 0047

    Dresden, 01307, Germany

  • Local Institution - 0048

    San Diego, California, 92108, United States

  • Local Institution - 0051

    Leiden, 2333 CL, Netherlands

  • Local Institution - 0055

    Clearwater, Florida, 33765, United States

  • Local Institution - 0062

    Las Vegas, Nevada, 89102, United States

  • Local Institution - 0064

    Cluj-Napoca, Cluj, 400006, Romania

  • Local Institution - 0065

    Bucharest, Bucharest, 11658, Romania

  • Local Institution - 0069

    Warsaw, 02-953, Poland

  • Local Institution - 0070

    Pilar, Buenos Aires, 1629, Argentina

  • Local Institution - 0071

    Dessau, 06847, Germany

  • Local Institution - 0072

    Sofia, 1618, Bulgaria

  • Local Institution - 0074

    Poznan, 61-848, Poland

  • Local Institution - 0075

    CABA, Buenos Aires F.D., 1430, Argentina

  • Skin Sciences

    Louisville, Kentucky, 40217, United States

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