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RECRUITING 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

NCT06500702 · View on ClinicalTrials.gov ↗

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.

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

275 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06500702 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Texas, Other, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06500702?

The interventions under investigation include: placebo (DRUG), rilzabrutinib (DRUG), frexalimab (DRUG), brivekimig (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06500702?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial