🏛️ Verified NIH Record • Updated 2026-08-05
Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus (NCT05039840)
Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus: A Randomized, Double Blind, Placebo-controlled, Phase 2, Proof of Concept Study
🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Sanofi
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: Accel Research Sites Network - Birmingham- Site Number : 8400003 — Vestavia Hills, Alabama
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (73 Sites)
Showing the first 25 of 73 sites.
- Accel Research Sites Network - Birmingham- Site Number : 8400003 — Vestavia Hills, Alabama
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler- Site Number : 8400026 — Chandler, Arizona
- Arizona Arthritis & Rheumatology Associates - South Vineyard Avenue- Site Number : 8400022 — Mesa, Arizona
- Arizona Arthritis & Rheumatology Research - Sun City- Site Number : 8400027 — Sun City, Arizona
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast- Site Number : 8400023 — Tucson, Arizona
- Saint John's Physician Partners- Site Number : 8400015 — Santa Monica, California
- Millennium Clinical Trials - Simi Valley- Site Number : 8400004 — Simi Valley, California
- Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400002 — DeBary, Florida
- Vitalia Medical Research - Margate- Site Number : 8400039 — Margate, Florida
- Innovia Research Center- Site Number : 8400037 — Miramar, Florida
- Integral Rheumatology and Immunology Specialists- Site Number : 8400014 — Plantation, Florida
- Infigo Clinical Research- Site Number : 8400016 — Sanford, Florida
- Inspire Santa Fe Medical Group- Site Number : 8400019 — Santa Fe, New Mexico
- Columbia University Irving Medical Center- Site Number : 8400009 — New York, New York
- RAO - Rheumatology Associates of Oklahoma- Site Number : 8400013 — Oklahoma City, Oklahoma
- Private Practice - Dr. Ramesh C. Gupta I- Site Number : 8400008 — Memphis, Tennessee
- Tekton Research - West Gate- Site Number : 8400001 — Austin, Texas
- Precision Comprehensive Clinical Research Solutions - Colleyville- Site Number : 8400017 — Colleyville, Texas
- Lone Start Arthritis & Rheumatology Associates- Site Number : 8400025 — Fort Worth, Texas
- Prolato Clinical Research Center- Site Number : 8400005 — Houston, Texas
- AARA Clinical Research - Lone Star Arthritis & Rheumatology Associates - Irving- Site Number : 8400024 — Irving, Texas
- West Texas Clinical Research- Site Number : 8400018 — Lubbock, Texas
- Investigational Site Number : 0320008 — Berazategui, Buenos Aires
- Investigational Site Number : 0320003 — San Miguel de Tucumán, Tucumán Province
- Investigational Site Number : 0320006 — Buenos Aires,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Systemic Lupus Erythematosus
- A Study of Obexelimab in Patients With Systemic Lupus Erythematosus — Peoria, Arizona
- A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus — Anniston, Alabama
- REACH (Restore Energy, Activity Can Help) Lupus Study — Boston, Massachusetts
- Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus — Birmingham, Alabama
- A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice — Innsbruck, Tyrol
- A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) — Birmingham, Alabama
Explore by condition: All Systemic Lupus Erythematosus clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.