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 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: ACT180642024-511775-15U1111-1301-2676
• Study Type: interventional
• Target: 84
• Locations: 22 countries
• Sites: 69

Brief 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.

Conditions

Focal Segmental Glomerulosclerosis; Glomerulonephritis Minimal Lesion

Outcome Measures

Primary Outcomes (1)

• Percent reduction in urine protein to creatinine ratio (UPCR)

  From baseline to Week 12

Secondary Outcomes (5)

• Percentage of participants achieving FSGS partial remission endpoint

  At Week 12

• Percentage of participants achieving CR

  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

  Treatment emergent period, up to Week 48

• Plasma concentrations of frexalimab and rilzabrutinib and serum concentrations of SAR442970

  Up to Week 48

• Occurrence of anti-drug antibodies (ADAs) against frexalimab and SAR442970

  Up to Week 48

Study Arms (4)

Frexalimab

EXPERIMENTAL

Frexalimab active dose

Drug: frexalimab

Brivekimig

EXPERIMENTAL

Brivekimig active dose

Drug: brivekimig

Rilzabrutinib

EXPERIMENTAL

Rilzabrutinib active dose

Drug: rilzabrutinib

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: placebo

Interventions

frexalimab DRUG

frexalimab treatment

Frexalimab

brivekimig DRUG

brivekimig treatment

Brivekimig

rilzabrutinib DRUG

rilzabrutinib treatment

Rilzabrutinib

placebo DRUG

placebo treatment

Placebo

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (69)

Investigational Site Number : 8400007

Birmingham, Alabama, 35233, United States

RECRUITING

Investigational Site Number : 8400015

Orange, California, 92868, United States

RECRUITING

Investigational Site Number : 8400012

San Francisco, California, 94143, United States

RECRUITING

Investigational Site Number : 8400025

Tampa, Florida, 33612, United States

RECRUITING

Investigational Site Number : 8400014

Chicago, Illinois, 60611, United States

RECRUITING

Investigational Site Number : 8400017

Hinsdale, Illinois, 60521, United States

RECRUITING

Investigational Site Number : 8400010

Ann Arbor, Michigan, 48109, United States

RECRUITING

Investigational Site Number : 8400019

Edina, Minnesota, 55435, United States

RECRUITING

Investigational Site Number : 8400018

Las Vegas, Nevada, 89107, United States

RECRUITING

Investigational Site Number: 8400028

Albuquerque, New Mexico, 87109, United States

RECRUITING

Investigational Site Number : 8400001

New York, New York, 10032, United States

RECRUITING

Investigational Site Number : 8400021

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Investigational Site Number : 8400024

Dallas, Texas, 75204, United States

RECRUITING

Investigational Site Number : 8400005

El Paso, Texas, 79902, United States

RECRUITING

Investigational Site Number: 8400016

Houston, Texas, 77054, United States

RECRUITING

Investigational Site Number : 0320001

Buenos Aires, 1431, Argentina

RECRUITING

Investigational Site Number : 0320002

Córdoba, 5016, Argentina

RECRUITING

Investigational Site Number : 0360003

Garran, Australian Capital Territory, 2605, Australia

RECRUITING

Investigational Site Number : 0360001

Parkville, Victoria, 3050, Australia

RECRUITING

Investigational Site Number: 0760004

Botucatu, São Paulo, 18618-970, Brazil

RECRUITING

Investigational Site Number : 0760002

São Paulo, 04038-002, Brazil

RECRUITING

Investigational Site Number : 0760001

São Paulo, 05403-000, Brazil

RECRUITING

Investigational Site Number : 1240002

London, Ontario, N6A 5A5, Canada

RECRUITING

Investigational Site Number : 1240001

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Investigational Site Number : 1240005

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

Investigational Site Number : 1240006

Québec, Quebec, G1R 2J6, Canada

RECRUITING

Investigational Site Number : 1520003

Temuco, La Araucanía, 4781151, Chile

RECRUITING

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 8330034, Chile

RECRUITING

Investigational Site Number : 1560001

Beijing, 100034, China

RECRUITING

Investigational Site Number : 1560003

Chengdu, 610072, China

RECRUITING

Investigational Site Number : 1560004

Shanghai, 200080, China

RECRUITING

Investigational Site Number : 2030002

Olomouc, 779 00, Czechia

RECRUITING

Investigational Site Number : 2030001

Prague, 128 08, Czechia

RECRUITING

Investigational Site Number : 2500002

Créteil, 94010, France

RECRUITING

Investigational Site Number : 2500001

Paris, 75015, France

RECRUITING

Investigational Site Number : 2760002

Berlin, 10117, Germany

RECRUITING

Investigational Site Number : 2760006

Dresden, 01307, Germany

RECRUITING

Investigational Site Number : 2760003

Hanover, 30625, Germany

RECRUITING

Investigational Site Number : 3000002

Athens, 115 27, Greece

RECRUITING

Investigational Site Number : 3000001

Heraklion, 711 10, Greece

RECRUITING

Investigational Site Number : 3000003

Ioannina, 455 00, Greece

RECRUITING

Investigational Site Number : 3480001

Budapest, 1085, Hungary

RECRUITING

Investigational Site Number : 3800002

Florence, Firenze, 50134, Italy

RECRUITING

Investigational Site Number : 3800003

Naples, Napoli, 80131, Italy

RECRUITING

Investigational Site Number : 3800001

Brescia, 25123, Italy

RECRUITING

Investigational Site Number : 4840005

Mexico City, Mexico City, 06720, Mexico

RECRUITING

Investigational Site Number : 4840001

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Investigational Site Number : 4840003

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Investigational Site Number : 5280001

Amsterdam, 1105 AZ, Netherlands

RECRUITING

Investigational Site Number : 6160004

Poznan, Greater Poland Voivodeship, 60-780, Poland

RECRUITING

Investigational Site Number : 6160001

Lodz, Lódzkie, 02-213, Poland

RECRUITING

Investigational Site Number : 6160002

Opole, Opole Voivodeship, 45-418, Poland

RECRUITING

Investigational Site Number : 6200003

Lisbon, 1050-099, Portugal

RECRUITING

Investigational Site Number : 6200002

Porto, 4434-502, Portugal

RECRUITING

Investigational Site Number : 7030003

Banská Bystrica, 975 17, Slovakia

RECRUITING

Investigational Site Number : 7030004

Bratislava - Kramare, 831 01, Slovakia

RECRUITING

Investigational Site Number : 7030001

Martin, 036 01, Slovakia

RECRUITING

Investigational Site Number : 7240001

Barcelona, Barcelona [Barcelona], 08035, Spain

RECRUITING

Investigational Site Number : 7240005

Seville, Sevilla, 41013, Spain

RECRUITING

Investigational Site Number : 7240002

Córdoba, 14004, Spain

RECRUITING

Investigational Site Number : 7240008

Madrid, 28007, Spain

RECRUITING

Investigational Site Number : 7240007

Madrid, 28040, Spain

RECRUITING

Investigational Site Number : 1580001

Taichung, 404, Taiwan

RECRUITING

Investigational Site Number : 1580002

Taipei, 100, Taiwan

RECRUITING

Investigational Site Number : 7920001

İzmit, 41001, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 7920002

Kayseri, 38039, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 8260001

Leicester, Leicestershire, LE5 4PW, United Kingdom

RECRUITING

Investigational Site Number : 8260004

Salford, Manchester, M6 8HD, United Kingdom

RECRUITING

Investigational Site Number : 8260005

Oxford, Oxfordshire, OX3 7LE, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 39899371 DERIVED

Related Links

• ACT18064 Plain Language Results Summary

MeSH Terms

Conditions

Glomerulosclerosis, Focal Segmental; Nephrosis, Lipoid

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrosis

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; contact-us@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: December 19, 2024
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): February 16, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

AR (2); TW (2); TU (2); ES (5); SL (3); GB (3); BR (3); HU (1); IT (3); CN (3); FR (2); US (15); CL (2); GR (3); ME (3); NL (1); PT (2); CA (4); DE (3); PL (3); AU (2); CZ (2)