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NCT06500702 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
A Phase 2 study of Focal Segmental Glomerulosclerosis and Glomerulonephritis Minimal Lesion, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
- 20
- Study locations
NCT06500702: Recruiting Phase 2 study of Focal Segmental Glomerulosclerosis and Glomerulonephritis Minimal Lesion, sponsored by Sanofi.
NCT06500702 is a Phase 2 study of Focal Segmental Glomerulosclerosis and Glomerulonephritis Minimal Lesion that is actively recruiting participants, run by Sanofi. The registered enrollment target is 84 participants, below the 232-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06500702, a Phase 2 study of Focal Segmental Glomerulosclerosis and Glomerulonephritis Minimal Lesion, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or primary minimal change disease (MCD). The purpose of this study is to measure the change in proteinuria and its impact on the rates of remission of nephrotic syndrome with frexalimab, brivekimig, or rilzabrutinib compared with placebo in participants with primary FSGS or primary MCD aged 16 to 75 years. Study details for each participant include: The study duration will be up to 76 weeks. The treatment duration will be 24 weeks. There will be up to 18 visits.
Conditions Studied
Interventions
- DRUG placebo
- DRUG rilzabrutinib
- DRUG frexalimab
- DRUG brivekimig
Study Locations (20)
Texas
- Investigational Site Number : 8400024 - Dallas
- Investigational Site Number : 8400005 - El Paso
- Investigational Site Number: 8400016 - Houston
Other
- Investigational Site Number : 0320001 - Buenos Aires
- Investigational Site Number : 0320002 - Córdoba
- Investigational Site Number : 0760002 - São Paulo
California
- Investigational Site Number : 8400015 - Orange
- Investigational Site Number : 8400012 - San Francisco
Illinois
- Investigational Site Number : 8400014 - Chicago
- Investigational Site Number : 8400017 - Hinsdale
Alabama
- Investigational Site Number : 8400007 - Birmingham
Florida
- Investigational Site Number : 8400025 - Tampa
Michigan
- Investigational Site Number : 8400010 - Ann Arbor
Minnesota
- Investigational Site Number : 8400019 - Edina
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2024-12-19 |
| Est. Completion | 2028-02-16 |
| Phase | Phase 2 |
What NCT06500702 shows while recruiting
NCT06500702 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 232-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (64% lower).
The record links to 2 conditions, with Focal Segmental Glomerulosclerosis appearing as the primary indexed condition, and to 4 interventions - of which placebo is the first listed.
NCT06500702 names 20 study sites across 14 states, led by Texas, Other, California.
Frequently Asked Questions
What is clinical trial NCT06500702 about?
NCT06500702 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease". This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or primary minimal change disease (MCD). The purpose of this study is to measure the change in proteinuria and its impact on the rates of remission of nephrotic syndrome wi...
What is the current status of trial NCT06500702?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2024-12-19. Estimated completion is 2028-02-16.
What conditions does trial NCT06500702 study?
This clinical trial studies the following conditions: Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion.
What interventions are being tested in trial NCT06500702?
The interventions under investigation include: placebo (DRUG), rilzabrutinib (DRUG), frexalimab (DRUG), brivekimig (DRUG).
Who is sponsoring clinical trial NCT06500702?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06500702 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06500702's enrollment target sits among peer trials
84 9th of 19 higher than 11 of 19 other Focal Segmental Glomerulosclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Focal Segmental Glomerulosclerosis 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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