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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 1

Conditions: Lupus

Treatments: Other: Placebo for BMS-986326; Drug: BMS-986326

Study type: Interventional

Funder types: Industry

Identifiers

NCT06013995

IM034-1000

2022-503009-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 8 patient groups

Cohort A: BMS-986326 Dose 1 IV

Experimental group

Treatment:

Drug: BMS-986326

Other: Placebo for BMS-986326

Cohort B: BMS-986326 Dose 2 IV

Experimental group

Treatment:

Drug: BMS-986326

Other: Placebo for BMS-986326

Cohort C1: BMS-986326 Dose 3 IV

Experimental group

Treatment:

Drug: BMS-986326

Other: Placebo for BMS-986326

Cohort C2: BMS-986326 Dose 3 SC

Experimental group

Treatment:

Drug: BMS-986326

Other: Placebo for BMS-986326

Cohort D1: BMS-986326 Dose 4 IV

Experimental group

Treatment:

Drug: BMS-986326

Other: Placebo for BMS-986326

Cohort D2: BMS-986326 Dose 4 SC

Experimental group

Treatment:

Drug: BMS-986326

Other: Placebo for BMS-986326

Cohort E1: BMS-986326 Dose 3 IV

Experimental group

Treatment:

Drug: BMS-986326

Other: Placebo for BMS-986326

Cohort E2: BMS-986326 Dose 3 SC

Experimental group

Treatment:

Drug: BMS-986326

Other: Placebo for BMS-986326