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

NCT05039840 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2026-03-27

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-10
Primary Completion
2026-07-10
Completion
2026-10-02
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Chile
  • Georgia
  • Greece
  • Hungary
  • Italy
  • Mauritius
  • Mexico
  • Puerto Rico
  • Russia
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05039840 on ClinicalTrials.gov