NCT05039840

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

Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus: A Randomized, Double Blind, Placebo-controlled, Phase 2, Proof of Concept Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	SAR441344 IV	Pharmaceutical form: solution Route of administration: Intravenous infusion
DRUG	SAR441344 SC	Pharmaceutical form: solution Route of administration: subcutaneous injection
DRUG	Placebo IV	Pharmaceutical form: solution Route of administration: Intravenous infusion
DRUG	Placebo SC	Pharmaceutical form: solution Route of administration: subcutaneous injection

Timeline

• Start date: 2021-11-10
• Primary completion: 2026-07-10
• Completion: 2026-10-02
• First posted: 2021-09-10
• Last updated: 2026-03-27

Locations

73 sites across 16 countries: United States, Argentina, Brazil, Chile, Georgia, Greece, Hungary, Italy, Mauritius, Mexico, Puerto Rico, Russia, Spain, Switzerland, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study