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 (RESULT)

June 4, 2026 updated by: Sanofi

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: contact-us@sanofi.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1431
        • Recruiting
        • Investigational Site Number : 0320001
      • Córdoba, Argentina, 5016
        • Recruiting
        • Investigational Site Number : 0320002
  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Recruiting
        • Investigational Site Number : 0360003
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Recruiting
        • Investigational Site Number : 0360001
  • Brazil
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • Investigational Site Number : 0760001
      • São Paulo, Brazil, 04038-002
        • Recruiting
        • Investigational Site Number : 0760002
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618-970
        • Recruiting
        • Investigational Site Number: 0760004
      • São Paulo, São Paulo, Brazil, 01139-000
        • Recruiting
        • Synvia Clinical- Site Number : 0760005
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • Investigational Site Number : 1240002
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Investigational Site Number : 1240001
      • Montreal, Quebec, Canada, H3T 1C5
        • Recruiting
        • Investigational Site Number : 1240005
      • Québec, Quebec, Canada, G1R 2J6
        • Recruiting
        • Investigational Site Number : 1240006
  • Chile
    • La Araucanía
      • Temuco, La Araucanía, Chile, 4781151
        • Recruiting
        • Investigational Site Number : 1520003
    • Reg Metropolitana de Santiago
      • Santiago, Reg Metropolitana de Santiago, Chile, 8330034
        • Recruiting
        • Investigational Site Number : 1520002
  • China
      • Beijing, China, 100034
        • Recruiting
        • Investigational Site Number : 1560001
      • Chengdu, China, 610072
        • Recruiting
        • Investigational Site Number : 1560003
      • Shanghai, China, 200080
        • Recruiting
        • Investigational Site Number : 1560004
  • Czechia
      • Olomouc, Czechia, 779 00
        • Recruiting
        • Investigational Site Number : 2030002
      • Prague, Czechia, 128 08
        • Recruiting
        • Investigational Site Number : 2030001
  • France
      • Créteil, France, 94010
        • Recruiting
        • Investigational Site Number : 2500002
      • Paris, France, 75015
        • Recruiting
        • Investigational Site Number : 2500001
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Investigational Site Number : 2760002
      • Dresden, Germany, 01307
        • Recruiting
        • Investigational Site Number : 2760006
      • Hanover, Germany, 30625
        • Recruiting
        • Investigational Site Number : 2760003
  • Greece
      • Athens, Greece, 115 27
        • Recruiting
        • Investigational Site Number : 3000002
      • Heraklion, Greece, 711 10
        • Recruiting
        • Investigational Site Number : 3000001
      • Ioannina, Greece, 455 00
        • Recruiting
        • Investigational Site Number : 3000003
  • Hungary
      • Budapest, Hungary, 1085
        • Recruiting
        • Investigational Site Number : 3480001
  • Italy
      • Brescia, Italy, 25123
        • Recruiting
        • Investigational Site Number : 3800001
    • Firenze
      • Florence, Firenze, Italy, 50134
        • Recruiting
        • Investigational Site Number : 3800002
    • Napoli
      • Naples, Napoli, Italy, 80131
        • Recruiting
        • Investigational Site Number : 3800003
  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 14080
        • Recruiting
        • Investigational Site Number : 4840001
      • Mexico City, Mexico City, Mexico, 06720
        • Recruiting
        • Investigational Site Number : 4840005
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Recruiting
        • Investigational Site Number : 4840003
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Recruiting
        • Investigational Site Number : 5280001
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-780
        • Recruiting
        • Investigational Site Number : 6160004
    • Lódzkie
      • Lodz, Lódzkie, Poland, 02-213
        • Recruiting
        • Investigational Site Number : 6160001
    • Opole Voivodeship
      • Opole, Opole Voivodeship, Poland, 45-418
        • Recruiting
        • Investigational Site Number : 6160002
  • Portugal
      • Lisbon, Portugal, 1050-099
        • Recruiting
        • Investigational Site Number : 6200003
      • Porto, Portugal, 4434-502
        • Recruiting
        • Investigational Site Number : 6200002
  • Slovakia
      • Banská Bystrica, Slovakia, 975 17
        • Recruiting
        • Investigational Site Number : 7030003
      • Bratislava - Kramare, Slovakia, 831 01
        • Recruiting
        • Investigational Site Number : 7030004
      • Martin, Slovakia, 036 01
        • Recruiting
        • Investigational Site Number : 7030001
  • Spain
      • Córdoba, Spain, 14004
        • Recruiting
        • Investigational Site Number : 7240002
      • Madrid, Spain, 28007
        • Recruiting
        • Investigational Site Number : 7240008
      • Madrid, Spain, 28040
        • Recruiting
        • Investigational Site Number : 7240007
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Recruiting
        • Investigational Site Number : 7240001
    • Sevilla
      • Seville, Sevilla, Spain, 41013
        • Recruiting
        • Investigational Site Number : 7240005
  • Taiwan
      • Taichung, Taiwan, 404
        • Recruiting
        • Investigational Site Number : 1580001
      • Taipei, Taiwan, 100
        • Recruiting
        • Investigational Site Number : 1580002
  • Turkey (Türkiye)
      • Kayseri, Turkey (Türkiye), 38039
        • Recruiting
        • Investigational Site Number : 7920002
      • İzmit, Turkey (Türkiye), 41001
        • Recruiting
        • Investigational Site Number : 7920001
  • United Kingdom
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE5 4PW
        • Recruiting
        • Investigational Site Number : 8260001
    • Manchester
      • Salford, Manchester, United Kingdom, M6 8HD
        • Recruiting
        • Investigational Site Number : 8260004
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Recruiting
        • Investigational Site Number : 8260005
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • Investigational Site Number : 8400007
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • Investigational Site Number : 8400015
      • San Francisco, California, United States, 94143
        • Recruiting
        • Investigational Site Number : 8400012
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Investigational Site Number : 8400025
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory Children's Center- Site Number : 8400020
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Investigational Site Number : 8400014
      • Hinsdale, Illinois, United States, 60521
        • Recruiting
        • Investigational Site Number : 8400017
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • Investigational Site Number : 8400010
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Investigational Site Number : 8400019
    • Nevada
      • Las Vegas, Nevada, United States, 89107
        • Recruiting
        • Investigational Site Number : 8400018
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Recruiting
        • Investigational Site Number: 8400028
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Investigational Site Number : 8400001
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • Investigational Site Number : 8400021
    • Texas
      • Dallas, Texas, United States, 75204
        • Recruiting
        • Investigational Site Number : 8400024
      • El Paso, Texas, United States, 79902
        • Recruiting
        • Investigational Site Number : 8400005
      • Houston, Texas, United States, 77054
        • Recruiting
        • Investigational Site Number: 8400016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Biopsy report indicative of primary FSGS or primary MCD, with supportive clinical presentation per Investigator's judgement.
  • UPCR ≥3 g/g at screening, or ≥ 1.5 g/g in those with eGFR ≥ 60.
  • eGFR ≥45 mL/min/1.73 m^2 at screening.
  • Documented history of UPCR (or 24-hour urine protein) reduction by >40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g (or pre-treatment 24-hr urine protein was ≥3.5 g/day if 24-hour urine protein is used).
  • ≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization.
  • For those on a RAAS inhibitor prior to screening, the dose must be stable ≥4 weeks prior to screening; starting RAAS inhibitors or changing the dose will not be allowed during the double-blind or OLE treatment period.
  • For those on an SGLT2 inhibitor prior to screening, the dose must be stable ≥4 weeks prior to screening; starting SGLT2 inhibitor treatment or changing the dose will not be allowed during the double-blind or OLE treatment periods.
  • Body weight within 45 to 120 kg (inclusive) at screening.

Exclusion Criteria:

  • Genetic or secondary FSGS or MCD. Those with APOL1 risk alleles are eligible.
  • Collapsing variant of FSGS.
  • ESKD requiring dialysis or transplantation.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo
Drug: placebo
placebo treatment
Experimental: Frexalimab
Frexalimab active dose
Drug: frexalimab
frexalimab treatment
Experimental: Rilzabrutinib
Rilzabrutinib active dose
Drug: rilzabrutinib
rilzabrutinib treatment
Experimental: Brivekimig
Brivekimig active dose
Drug: brivekimig
brivekimig treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent reduction in urine protein to creatinine ratio (UPCR)
Time Frame: From baseline to Week 12
From baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving FSGS partial remission endpoint
Time Frame: At Week 12
Defined as UPCR ≤1.5 g/g and >40 % reduction of UPCR from baseline
At Week 12
Percentage of participants achieving CR
Time Frame: At Week 12
Defined as UPCR ≤0.3 g/g
At Week 12
Incidence of treatment-emergent adverse events, treatment-emergent serious adverse events (SAEs), treatment-emergent adverse events of special interest (AESIs) and IMP discontinuation due to TEAEs during the study
Time Frame: Treatment emergent period, up to Week 48
TEAEs, including clinically significant changes in vital signs, electrocardiogram [ECG], and laboratory evaluation
Treatment emergent period, up to Week 48
Plasma concentrations of frexalimab and rilzabrutinib and serum concentrations of SAR442970
Time Frame: Up to Week 48
Up to Week 48
Occurrence of anti-drug antibodies (ADAs) against frexalimab and SAR442970
Time Frame: Up to Week 48
Up to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2024

Primary Completion (Estimated)

December 23, 2026

Study Completion (Estimated)

February 16, 2028

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT18064
  • 2024-511775-15 (Registry Identifier: CTIS)
  • U1111-1301-2676 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Focal Segmental Glomerulosclerosis

Clinical Trials on frexalimab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe