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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 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.

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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

Focal Segmental Glomerulosclerosis Glomerulonephritis Minimal Lesion

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

FieldValue
Enrollment Target 84 participants
Start Date 2024-12-19
Est. Completion 2028-02-16
Phase Phase 2

Sponsor

Sanofi

713 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06500702

The ClinicalTrials.gov registry entry for NCT06500702 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 232-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (64% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.