Focal Segmental GlomerulosclerosisPhase 2RESULTNCT06500702
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 testing frexalimab, brivekimig and rilzabrutinib in people with Focal Segmental Glomerulosclerosis and Glomerulonephritis Minimal Lesion, run by Sanofi at 79 sites in 22 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion
- What is being tested?
- frexalimab, brivekimig and rilzabrutinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 79 sitesin 22 countries
- Study dates
- 19 Dec 2024to 16 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
79 sites in 22 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
79 sites in 22 countries
United States18 sites, 17 recruiting
- Recruiting
Renal Medicine Associates- Site Number : 8400028
Albuquerque, New Mexico, 87109
- Recruiting
University of Michigan Health System - Ann Arbor- Site Number : 8400010
Ann Arbor, Michigan, 48109
- Recruiting
Emory Children's Center- Site Number : 8400020
Atlanta, Georgia, 30322
- Recruiting
University of Alabama -The Kirklin Clinic- Site Number : 8400007
Birmingham, Alabama, 35233
- Recruiting
UNC Kidney Center- Site Number : 8400021
Chapel Hill, North Carolina, 27599
- Recruiting
Northwestern Memorial Hospital- Site Number : 8400014
Chicago, Illinois, 60611
- Recruiting
Cleveland Clinic - Cleveland- Site Number : 8400029
Cleveland, Ohio, 44195
- Recruiting
Renal Disease Research Institute - Dallas - Live Oak Street- Site Number : 8400024
Dallas, Texas, 75204
- Recruiting
InterMed Consultants - Edina Clinic- Site Number : 8400019
Edina, Minnesota, 55435
- Recruiting
El Paso Kidney Specialists- Site Number : 8400005
El Paso, Texas, 79902
- Recruiting
Nephrology Associates of Northern Illinois and Indiana (NANI) - Hinsdale- Site Number : 8400017
Hinsdale, Illinois, 60521
- Recruiting
Prolato Clinical Research Center- Site Number : 8400016
Houston, Texas, 77054
- Active, not recruiting
DaVita Clinical Research - Las Vegas - North Rainbow Boulevard- Site Number : 8400018
Las Vegas, Nevada, 89107
- Recruiting
Columbia University Irving Medical Center- Site Number : 8400001
New York, New York, 10032
- Recruiting
University of California Irvine Medical Center- Site Number : 8400015
Orange, California, 92868
- Recruiting
University of California San Francisco - Parnassus Heights- Site Number : 8400012
San Francisco, California, 94143
- Recruiting
University Of South Florida - Parent- Site Number : 8400025
Tampa, Florida, 33612
- Recruiting
The Children's Hospital at Montefiore- Site Number : 8400027
The Bronx, New York, 10467
Spain6 sites, 6 recruiting
- Recruiting
Investigational Site Number : 7240001
Barcelona, Catalunya [Cataluña], 08035
- Recruiting
Investigational Site Number : 7240002
Córdoba, 14004
- Recruiting
Investigational Site Number : 7240008
Madrid, 28007
- Recruiting
Investigational Site Number : 7240007
Madrid, 28040
- Recruiting
Investigational Site Number : 7240009
Pamplona, Navarre, 31008
- Recruiting
Investigational Site Number : 7240005
Seville, Andalusia, 41013
Canada5 sites, 5 recruiting
- Recruiting
Investigational Site Number : 1240002
London, Ontario, N6A 5A5
- Recruiting
Investigational Site Number : 1240001
Montreal, Quebec, H1T 2M4
- Recruiting
Investigational Site Number : 1240005
Montreal, Quebec, H3T 1C5
- Recruiting
Investigational Site Number : 1240006
Québec, Quebec, G1R 2J6
- Recruiting
Investigational Site Number : 1240004
Toronto, Ontario, M5G 1X8
Brazil4 sites, 4 recruiting
- Recruiting
Universidade Estadual Paulista - Faculdade de Medicina de Botucatu- Site Number : 0760004
Botucatu, São Paulo, 18618-970
- Recruiting
Synvia Clinical- Site Number : 0760005
São Paulo, São Paulo, 01139-000
- Recruiting
Hospital do Rim e Hipertensão- Site Number : 0760002
São Paulo, 04038-002
- Recruiting
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760001
São Paulo, 05403-000
Italy4 sites, 4 recruiting
- Recruiting
Investigational Site Number : 3800001
Brescia, 25123
- Recruiting
Investigational Site Number : 3800002
Florence, Firenze, 50134
- Recruiting
Investigational Site Number : 3800004
Monza, 20900
- Recruiting
Investigational Site Number : 3800003
Naples, Napoli, 80131
China3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 1560001
Beijing, 100034
- Recruiting
Investigational Site Number : 1560003
Chengdu, 610072
- Recruiting
Investigational Site Number : 1560004
Shanghai, 200080
Germany3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 2760002
Berlin, 10117
- Recruiting
Investigational Site Number : 2760006
Dresden, 01307
- Recruiting
Investigational Site Number : 2760003
Hanover, 30625
Greece3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 3000002
Athens, 115 27
- Recruiting
Investigational Site Number : 3000001
Heraklion, 711 10
- Recruiting
Investigational Site Number : 3000003
Ioannina, 455 00
Hungary3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 3480001
Budapest, 1085
- Recruiting
Investigational Site Number : 3480005
Pécs, 7624
- Recruiting
Investigational Site Number : 3480006
Szeged, 6725
Mexico3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 4840005
Mexico City, 06720
- Recruiting
Investigational Site Number : 4840001
Mexico City, 14080
- Recruiting
Investigational Site Number : 4840003
Monterrey, Nuevo León, 64460
Poland3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 6160001
Lodz, Lódzkie, 02-213
- Recruiting
Investigational Site Number : 6160002
Opole, Opole Voivodeship, 45-418
- Recruiting
Investigational Site Number : 6160004
Poznan, Greater Poland Voivodeship, 60-780
Portugal3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 6200004
Carnaxide, 2790-134
- Recruiting
Investigational Site Number : 6200003
Lisbon, 1050-099
- Recruiting
Investigational Site Number : 6200002
Porto, 4434-502
Slovakia3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 7030003
Banská Bystrica, 975 17
- Recruiting
Investigational Site Number : 7030004
Bratislava - Kramare, 831 01
- Recruiting
Investigational Site Number : 7030001
Martin, 036 01
United Kingdom3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 8260001
Leicester, Leicestershire, LE5 4PW
- Recruiting
Investigational Site Number : 8260005
Oxford, Oxfordshire, OX3 7LE
- Recruiting
Investigational Site Number : 8260004
Salford, Manchester, M6 8HD
Argentina2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 0320001
Buenos Aires, 1431
- Recruiting
Investigational Site Number : 0320002
Córdoba, 5016
Australia2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 0360003
Garran, Australian Capital Territory, 2605
- Recruiting
Investigational Site Number : 0360001
Parkville, Victoria, 3050
Chile2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, 8330034
- Recruiting
Investigational Site Number : 1520003
Temuco, La Araucanía, 4781151
Czechia2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 2030002
Olomouc, 779 00
- Recruiting
Investigational Site Number : 2030001
Prague, 128 08
France2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 2500002
Créteil, 94010
- Recruiting
Investigational Site Number : 2500001
Paris, 75015
Taiwan2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 1580001
Taichung, 404
- Recruiting
Investigational Site Number : 1580002
Taipei, 100
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 7920001
İzmit, 41001
- Recruiting
Investigational Site Number : 7920002
Kayseri, 38039
Netherlands1 site, 1 recruiting
- Recruiting
Investigational Site Number : 5280001
Amsterdam, 1105 AZ
About this study
Official title: 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.
- Being tested
- frexalimab, brivekimig, rilzabrutinib, placebo
- Medical subject headings
- Glomerulosclerosis, Focal Segmental, Nephrosis, Lipoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
frexalimabDrug
frexalimab treatment
brivekimigDrug
brivekimig treatment
rilzabrutinibDrug
rilzabrutinib treatment
placeboDrug
placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| Frexalimab | Experimental | Frexalimab active dose Receives: Drug: frexalimab |
| Brivekimig | Experimental | Brivekimig active dose Receives: Drug: brivekimig |
| Rilzabrutinib | Experimental | Rilzabrutinib active dose Receives: Drug: rilzabrutinib |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction in urine protein to creatinine ratio (UPCR)
Measured: From baseline to Week 12
Secondary outcomes (5)
Percentage of participants achieving FSGS partial remission endpoint
Defined as UPCR ≤1.5 g/g and >40 % reduction of UPCR from baseline
Measured: At Week 12
Percentage of participants achieving CR
Defined as UPCR ≤0.3 g/g
Measured: 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
TEAEs, including clinically significant changes in vital signs, electrocardiogram [ECG], and laboratory evaluation
Measured: Treatment emergent period, up to Week 48
Plasma concentrations of frexalimab and rilzabrutinib and serum concentrations of SAR442970
Measured: Up to Week 48
Occurrence of anti-drug antibodies (ADAs) against frexalimab and SAR442970
Measured: Up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start19 Dec 2024
- Primary completion23 Dec 2026 (estimated)
- Study completion16 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Focal Segmental GlomerulosclerosisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500702
- Sponsor's protocol ID
- ACT18064
- Other IDs
- 2024-511775-15, U1111-1301-2676
- Acronym
- RESULT
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
Lin J, Radhakrishnan J. What Are Baskets, Umbrellas, and Platforms Doing in Nephrology Clinical Trials? J Am Soc Nephrol. 2025 Feb 3;36(8):1652-1654. doi: 10.1681/ASN.0000000648. No abstract available.
PubMed 39899371
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06500702
- Acronym / sponsor ID
- RESULT / ACT18064
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 23 Dec 2026 (estimated)
- Study completion
- 16 Feb 2028 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Frexalimab | Experimental | Drug: frexalimabFrexalimab active dose |
| Brivekimig | Experimental | Drug: brivekimigBrivekimig active dose |
| Rilzabrutinib | Experimental | Drug: rilzabrutinibRilzabrutinib active dose |
| Placebo | Placebo comparator | Drug: placeboMatching placebo |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| frexalimabfrexalimab treatment | Drug | Frexalimab |
| brivekimigbrivekimig treatment | Drug | Brivekimig |
| rilzabrutinibrilzabrutinib treatment | Drug | Rilzabrutinib |
| placeboplacebo treatment | Drug | Placebo |
Primary outcome
Percent reduction in urine protein to creatinine ratio (UPCR)
Time frame: From baseline to Week 12
5 secondary outcomes
Percentage of participants achieving FSGS partial remission endpoint
Time frame: At Week 12
Percentage of participants achieving CR
Time frame: 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
Plasma concentrations of frexalimab and rilzabrutinib and serum concentrations of SAR442970
Time frame: Up to Week 48
Occurrence of anti-drug antibodies (ADAs) against frexalimab and SAR442970
Time frame: Up to Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Derived from this study: PubMed 39899371Lin J, Radhakrishnan J. What Are Baskets, Umbrellas, and Platforms Doing in Nephrology Clinical Trials? J Am Soc Nephrol. 2025 Feb 3;36(8):1652-1654. doi: 10.1681/ASN.0000000648. No abstract available.
- ACT18064 Plain Language Results SummaryLink provided by the sponsor.
- For EU sites click here and navigate to 'Locations and contact points'Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial Transparency email recommended (Toll free for US & Canada) contact
79 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing frexalimab, brivekimig and rilzabrutinib in people with Focal Segmental Glomerulosclerosis and Glomerulonephritis Minimal Lesion, run by Sanofi at 79 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, Spain, Canada, Brazil, Italy and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, contact-us@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent reduction in urine protein to creatinine ratio (UPCR) (time frame: From baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06500702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.