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SAR448501

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

Ensayo de Sanofi en Systemic Lupus Erythematosus (SLE) · Rheumatoid Arthritis (RA) (del registro, en inglés).

Fase

Fase 1

Estado

Reclutando pacientes

Participantes

62

previstos

Centros

7

Fin del objetivo primario

jun 2029

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en mar 2025.

Qué mide

Incidence of treatment-emergent adverse events (TEAEs) (Baseline to Week 52 (End of Study (EOS))) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is an open-label, multi-ascending dose (MAD) phase 1 study, with dose expansion at selected doses, in adult patients with select autoimmune rheumatic diseases including systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The purpose of the study is to identify possible optimal dose(s) by assessing the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary clinical response of SAR448501/DR-0201. The study duration per participant will be a minimum of approximately 13 months, including a screening period of up to 28 days, a treatment period of 71 days, and a follow-up period of 42 weeks. If necessary, participants will continue to have visits after End of Study (EOS) every 4 weeks until peripheral blood B cells return to at least 80% of either the lower limit of normal (LLN) or the participant's baseline value.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06647069), actualizada en may 2026.