drugset / Trial / NCT05039840

Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus

NCT05039840

Phase 2 Active not recruiting 109 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multinational, randomized, placebo-controlled, parallel treatment, Phase 2, double-blind, 2 arm study evaluating the efficacy and safety of SAR441344 in comparison with placebo in the treatment of participants aged 18 to 70 years with active Systemic Lupus Erythematosus (SLE). Study details include: * Study duration: 36 weeks * Treatment duration: 24 weeks * Visit frequency: every 2 weeks

Timeline

Start
2021-11-10
Primary completion
2026-07-10
Completion
2026-10-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Frexalimab Monoclonal antibody Intravenous