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  • NCT06013995

Recruiting

A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus - IM034-1000

Updated: 22 February, 2024   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.
Print this page IM034-1000
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SELECT LANGUAGE

Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18-75

    Age Range

  • 15

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Cohort A: BMS-986326 Dose 1 IV
Drug: BMS-986326 Other: Placebo for BMS-986326
Experimental: Cohort B: BMS-986326 Dose 2 IV
Drug: BMS-986326 Other: Placebo for BMS-986326
Experimental: Cohort C1: BMS-986326 Dose 3 IV
Drug: BMS-986326 Other: Placebo for BMS-986326
Experimental: Cohort C2: BMS-986326 Dose 3 SC
Drug: BMS-986326 Other: Placebo for BMS-986326
Experimental: Cohort D1: BMS-986326 Dose 4 IV
Drug: BMS-986326 Other: Placebo for BMS-986326
Experimental: Cohort D2: BMS-986326 Dose 4 SC
Drug: BMS-986326 Other: Placebo for BMS-986326
Experimental: Cohort E1: BMS-986326 Dose 3 IV
Drug: BMS-986326 Other: Placebo for BMS-986326
Experimental: Cohort E2: BMS-986326 Dose 3 SC
Drug: BMS-986326 Other: Placebo for BMS-986326

Key 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.

If you want to report a side effect, you can report directly to the Danish Medicines Agency via the website www.meldenbivirkning.dk
We recommend that you also contact BMS to report side effects.
Side effects and other reportable events are defined here
Report side effects or product quality complaints: Medical Information

466-DK-2200001