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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

Oppdatert: 22 februar, 2024   |   ClinicalTrials.gov

Utskriftsvennlig Sammendrag

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Vis detaljer

  • Phase 1

    Fase

  • Kjønn

  • 18-75

    Aldersgruppe

  • 15

    Sted(er)

  • Recruiting

Behandlingsalternativer

Studiearmer
TILDELT INTERVENSJON
Experimental: Cohort A: BMS-986326 Dose 1 IV
Other: Placebo for BMS-986326 Drug: 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

Nøkkelkriterier for kvalifikasjon

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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Bivirkninger (uønskede hendelser) og andre rapporterbare hendelser er definert her
For å rapportere bivirkninger (uønskede hendelser) eller reklamere på et legemiddel: Medisinsk informasjon

MLTNO2000046