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RECRUITING Phase 2

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

NCT05039840 · View on ClinicalTrials.gov ↗

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

Interventions

  • DRUG SAR441344 IV
  • DRUG SAR441344 SC
  • DRUG Placebo IV
  • DRUG Placebo SC

Study Locations (20)

Florida

  • Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400002 — DeBary
  • Vitalia Medical Research - Margate- Site Number : 8400039 — Margate
  • Innovia Research Center- Site Number : 8400037 — Miramar
  • Integral Rheumatology and Immunology Specialists- Site Number : 8400014 — Plantation
  • Infigo Clinical Research- Site Number : 8400016 — Sanford

Arizona

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler- Site Number : 8400026 — Chandler
  • Arizona Arthritis & Rheumatology Associates - South Vineyard Avenue- Site Number : 8400022 — Mesa
  • Arizona Arthritis & Rheumatology Research - Sun City- Site Number : 8400027 — Sun City
  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast- Site Number : 8400023 — Tucson

Texas

  • Tekton Research - West Gate- Site Number : 8400001 — Austin
  • Precision Comprehensive Clinical Research Solutions - Colleyville- Site Number : 8400017 — Colleyville
  • Lone Start Arthritis & Rheumatology Associates- Site Number : 8400025 — Fort Worth
  • Prolato Clinical Research Center- Site Number : 8400005 — Houston

California

  • Saint John's Physician Partners- Site Number : 8400015 — Santa Monica
  • Millennium Clinical Trials - Simi Valley- Site Number : 8400004 — Simi Valley

Alabama

  • Accel Research Sites Network - Birmingham- Site Number : 8400003 — Vestavia Hills

New Mexico

  • Inspire Santa Fe Medical Group- Site Number : 8400019 — Santa Fe

New York

  • Columbia University Irving Medical Center- Site Number : 8400009 — New York

Oklahoma

  • RAO - Rheumatology Associates of Oklahoma- Site Number : 8400013 — Oklahoma City

Trial Details

FieldValue
Enrollment Target 116 participants
Start Date 2021-11-10
Est. Completion 2026-10-02
Phase Phase 2

Sponsor

Sanofi

275 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05039840

The ClinicalTrials.gov registry entry for NCT05039840 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 4 interventions — of which SAR441344 IV is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05039840 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, Arizona, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05039840 about?

NCT05039840 is a clinical study titled "Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus". 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 detail...

What is the current status of trial NCT05039840?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 116 participants. The study started on 2021-11-10. Estimated completion is 2026-10-02.

What conditions does trial NCT05039840 study?

This clinical trial studies the following conditions: Systemic Lupus Erythematosus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05039840?

The interventions under investigation include: SAR441344 IV (DRUG), SAR441344 SC (DRUG), Placebo IV (DRUG), Placebo SC (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05039840?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05039840 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial