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NCT05039840 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus
A Phase 2 study of Systemic Lupus Erythematosus, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 116
- Enrollment target
- 20
- Study locations
NCT05039840: Recruiting Phase 2 study of Systemic Lupus Erythematosus, sponsored by Sanofi.
NCT05039840 is a Phase 2 study of Systemic Lupus Erythematosus that is actively recruiting participants, run by Sanofi. The registered enrollment target is 116 participants, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05039840, a Phase 2 study of Systemic Lupus Erythematosus, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 116 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
A composite endpoint, with SRI-4 response requiring a ≥ 4-point improvement (reduction) from baseline in Hybrid Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (hSELENA-SLEDAI), no new British Isles Lupus Assessment Group (BILAG-2004) A organ domain scores, or ≥ 2 new BILAG-2004 B organ domain scores compared with baseline, no worsening from baseline in lupus disease activity, and no permanent discontinuation of study drug or u
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2021-11-10 |
| Est. Completion | 2026-10-02 |
| Phase | Phase 2 |
What NCT05039840 shows while recruiting
NCT05039840 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (69% lower).
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.
NCT05039840 names 20 study sites across 9 states, led by Florida, Arizona, Texas.
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.
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).
Who is sponsoring clinical trial NCT05039840?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05039840's enrollment target sits among peer trials
116 52nd of 99 higher than 48 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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