🏛️ Verified NIH Record • Updated 2026-07-16

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)

A Parallel-group Treatment, Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Umbrella Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, and Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Sanofi

🩺 Plain-English Summary (8th-Grade Level)

This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or 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 MCD aged 16 to 75 years. Study details for each participant include: The study duration will be up to 52 weeks. The treatment duration will be 24 weeks. There will be up to 16 visits.

Who can join: Review the eligibility criteria below.

Location: Investigational Site Number : 8400007 — Birmingham, Alabama

Age range: 16 Years to 75 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (71 Sites)

Showing the first 25 of 71 sites.

  • Investigational Site Number : 8400007 — Birmingham, Alabama
  • Investigational Site Number : 8400015 — Orange, California
  • Investigational Site Number : 8400012 — San Francisco, California
  • Investigational Site Number : 8400025 — Tampa, Florida
  • Emory Children's Center- Site Number : 8400020 — Atlanta, Georgia
  • Investigational Site Number : 8400014 — Chicago, Illinois
  • Investigational Site Number : 8400017 — Hinsdale, Illinois
  • Investigational Site Number : 8400010 — Ann Arbor, Michigan
  • Investigational Site Number : 8400019 — Edina, Minnesota
  • Investigational Site Number : 8400018 — Las Vegas, Nevada
  • Investigational Site Number: 8400028 — Albuquerque, New Mexico
  • Investigational Site Number : 8400001 — New York, New York
  • Investigational Site Number : 8400021 — Chapel Hill, North Carolina
  • Investigational Site Number : 8400024 — Dallas, Texas
  • Investigational Site Number : 8400005 — El Paso, Texas
  • Investigational Site Number: 8400016 — Houston, Texas
  • Investigational Site Number : 0320001 — Buenos Aires,
  • Investigational Site Number : 0320002 — Córdoba,
  • Investigational Site Number : 0360003 — Garran, Australian Capital Territory
  • Investigational Site Number : 0360001 — Parkville, Victoria
  • Investigational Site Number: 0760004 — Botucatu, São Paulo
  • Synvia Clinical- Site Number : 0760005 — São Paulo, São Paulo
  • Investigational Site Number : 0760002 — São Paulo,
  • Investigational Site Number : 0760001 — São Paulo,
  • Investigational Site Number : 1240002 — London, Ontario

📞 Contact the Study Coordinator

Phone: (800) 633-1610

Email: contact-us@sanofi.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗