RECRUITING

A Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease

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Conditions

Focal Segmental GlomerulosclerosisGlomerulonephritis Minimal Lesion

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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, SAR442970, 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.

Official Title

A Parallel-group Treatment, Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Umbrella Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, and Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

Quick Facts

Study Start:2024-08-22
Study Completion:2028-02-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06500702

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.

Ages Eligible for Study:16 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Biopsy-proven primary FSGS or primary MCD.
  2. * UPCR ≥3 g/g at screening.
  3. * eGFR ≥45 mL/min/1.73 m\^2 at screening.
  4. * Documented history of UPCR reduction by ≥40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g.
  5. * ≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization.
  6. * On stable dose of RAAS inhibitors for ≥4 weeks prior to screening (if applicable); starting RAAS inhibitors treatment will not be allowed during the double-blind or OLE treatment period.
  7. * On stable dose of SGLT2 inhibitor for ≥4 weeks prior to screening (if applicable); starting SGLT2 inhibitor treatment will not be allowed during the double-blind or OLE treatment periods.
  8. * Body weight within 45 to 120 kg (inclusive) at screening.
  1. * Genetic or secondary FSGS or MCD. Those with APOL1 risk alleles are eligible.
  2. * Collapsing variant of FSGS.
  3. * ESKD requiring dialysis or transplantation.

Contacts and Locations

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
800-633-1610
contact-us@sanofi.com

Study Locations (Sites)

Investigational Site Number : 8400005
El Paso, Texas, 79902
United States

Collaborators and Investigators

Sponsor: Sanofi

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 Registration Dates

Study Start Date2024-08-22
Study Completion Date2028-02-16

Study Record Updates

Study Start Date2024-08-22
Study Completion Date2028-02-16

Terms related to this study

Additional Relevant MeSH Terms

  • Focal Segmental Glomerulosclerosis
  • Glomerulonephritis Minimal Lesion