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

ReclutandoFase 1ClinicalTrials.gov

ID: NCT06013995Tipo: INTERVENTIONALInicio: 21 de sept de 2023Fin estimado: 12 de abr de 2026

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

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).

Criterios de exclusión

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.

Intervenciones

drug

BMS-986326

Specified dose on specified days

other

Placebo for BMS-986326

Specified dose on specified days

Ubicaciones

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

Pablo Maid, Site 0070 · 0000000000

RECRUITING

Clinica Adventista Belgrano

CABA, Buenos Aires F.D., Argentina

Federico Ariel, Site 0075 · +5491124691447

RECRUITING

Patrocinadores

PrincipalBristol-Myers Squibb

Contactos

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

Clinical.Trials@bms.com 855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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