Clinical Trial

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

Study acronym: APATURA
Active, Not Recruiting Phase 2
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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
Protocol Amendment History 3 changes
notable Primary completion pushed: 2026-07-10 -> 2026-09-03 2026-08-07
minor Completion pushed: 2026-10-02 -> 2026-11-24 2026-08-07
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-03-27
Trial Details
NCT Number NCT05039840
Lead Sponsor Sanofi
Conditions Systemic Lupus Erythematosus
Enrollment 109 participants
Start Date 2021-11-10
Primary Completion 2026-09-03 (estimated)
Study Completion 2026-11-24 (estimated)
Updated on ClinicalTrials.gov 2026-08-06