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)

July 16, 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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Biopsy report indicative of primary FSGS or 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 mL/min/1.73 m2.
  • eGFR ≥45 mL/min/1.73 m^2 at screening.
  • Documented history of UPCR or UACR (or 24-hour urine protein or 24-hour urine albumin) reduction by >40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g or equivalent for UACR (or pre-treatment 24-hr urine protein was ≥3.5 g/day if 24-hour urine protein is used or equivalent for 24-hr urine albumin if 24-hour urine albumin 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 16, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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