Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus
Public ClinicalTrials.gov record NCT05039840. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus: A Randomized, Double Blind, Placebo-controlled, Phase 2, Proof of Concept Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT05039840
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 109 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 10, 2021 (Actual)
- Primary completion
- Sep 4, 2026 (Actual)
- Completion
- Nov 24, 2026 (Estimated)
- Last update posted
- Sep 22, 2026
2021 – 2026
United States locations
- U.S. sites
- 22
- U.S. states
- 9
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Accel Research Sites Network - Birmingham- Site Number : 8400003 | Vestavia Hills | Alabama | 35216 | — |
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler- Site Number : 8400026 | Chandler | Arizona | 85225 | — |
| Arizona Arthritis & Rheumatology Associates - South Vineyard Avenue- Site Number : 8400022 | Mesa | Arizona | 85210 | — |
| Arizona Arthritis & Rheumatology Research - Sun City- Site Number : 8400027 | Sun City | Arizona | 85351 | — |
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast- Site Number : 8400023 | Tucson | Arizona | 85748 | — |
| Saint John's Physician Partners- Site Number : 8400015 | Santa Monica | California | 90404 | — |
| Millennium Clinical Trials - Simi Valley- Site Number : 8400004 | Simi Valley | California | 93065 | — |
| Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400002 | DeBary | Florida | 32713 | — |
| Vitalia Medical Research - Margate- Site Number : 8400039 | Margate | Florida | 33063 | — |
| Innovia Research Center- Site Number : 8400037 | Miramar | Florida | 33027 | — |
| Integral Rheumatology and Immunology Specialists- Site Number : 8400014 | Plantation | Florida | 33324 | — |
| Infigo Clinical Research- Site Number : 8400016 | Sanford | Florida | 32771 | — |
| Inspire Santa Fe Medical Group- Site Number : 8400019 | Santa Fe | New Mexico | 87505 | — |
| Columbia University Irving Medical Center- Site Number : 8400009 | New York | New York | 10032 | — |
| RAO - Rheumatology Associates of Oklahoma- Site Number : 8400013 | Oklahoma City | Oklahoma | 73116 | — |
| Private Practice - Dr. Ramesh C. Gupta I- Site Number : 8400008 | Memphis | Tennessee | 38119 | — |
| Tekton Research - West Gate- Site Number : 8400001 | Austin | Texas | 78745 | — |
| Precision Comprehensive Clinical Research Solutions - Colleyville- Site Number : 8400017 | Colleyville | Texas | 76034 | — |
| Lone Start Arthritis & Rheumatology Associates- Site Number : 8400025 | Fort Worth | Texas | 76109 | — |
| Prolato Clinical Research Center- Site Number : 8400005 | Houston | Texas | 77054 | — |
| AARA Clinical Research - Lone Star Arthritis & Rheumatology Associates - Irving- Site Number : 8400024 | Irving | Texas | 75039 | — |
| West Texas Clinical Research- Site Number : 8400018 | Lubbock | Texas | 79410 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 51 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05039840, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 22, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05039840 live on ClinicalTrials.gov.