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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Sanofi
Study ID
NCT06500702
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Focal Segmental Glomerulosclerosis
  • Glomerulonephritis Minimal Lesion

Eligibility Criteria

Sex
ALL
Age
16 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • frexalimab — DRUG
    frexalimab treatment
  • brivekimig — DRUG
    brivekimig treatment
  • rilzabrutinib — DRUG
    rilzabrutinib treatment
  • placebo — DRUG
    placebo treatment

Study Details

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.

Key Dates

First listed
Jul 15, 2024
Start date
Dec 19, 2024
Status verified
Sep 2026
Primary completion
Dec 23, 2026
Completion
Feb 16, 2028

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Frexalimab
    Frexalimab active dose
  • Experimental: Brivekimig
    Brivekimig active dose
  • Experimental: Rilzabrutinib
    Rilzabrutinib active dose
  • Placebo Comparator: Placebo
    Matching placebo

Primary Outcome Measure

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

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (18)

FacilityCityStateZIPSite coordinators
University of Alabama -The Kirklin Clinic- Site Number : 8400007BirminghamAlabama35233-
University of California Irvine Medical Center- Site Number : 8400015OrangeCalifornia92868-
University of California San Francisco - Parnassus Heights- Site Number : 8400012San FranciscoCalifornia94143-
University Of South Florida - Parent- Site Number : 8400025TampaFlorida33612-
Emory Children's Center- Site Number : 8400020AtlantaGeorgia30322-
Northwestern Memorial Hospital- Site Number : 8400014ChicagoIllinois60611-
Nephrology Associates of Northern Illinois and Indiana (NANI) - Hinsdale- Site Number : 8400017HinsdaleIllinois60521-
University of Michigan Health System - Ann Arbor- Site Number : 8400010Ann ArborMichigan48109-
InterMed Consultants - Edina Clinic- Site Number : 8400019EdinaMinnesota55435-
DaVita Clinical Research - Las Vegas - North Rainbow Boulevard- Site Number : 8400018Las VegasNevada89107-
Renal Medicine Associates- Site Number : 8400028AlbuquerqueNew Mexico87109-
Columbia University Irving Medical Center- Site Number : 8400001New YorkNew York10032-
The Children's Hospital at Montefiore- Site Number : 8400027The BronxNew York10467-
UNC Kidney Center- Site Number : 8400021Chapel HillNorth Carolina27599-
Cleveland Clinic - Cleveland- Site Number : 8400029ClevelandOhio44195-
Renal Disease Research Institute - Dallas - Live Oak Street- Site Number : 8400024DallasTexas75204-
El Paso Kidney Specialists- Site Number : 8400005El PasoTexas79902-
Prolato Clinical Research Center- Site Number : 8400016HoustonTexas77054-

Find similar trials in Birmingham, AL

By research site
University of Alabama -The Kirklin Clinic· Birmingham, ALUniversity of California Irvine Medical Center· Orange, CAUniversity of California San Francisco - Parnassus Heights· San Francisco, CAUniversity Of South Florida - Parent· Tampa, FLEmory Children's Center· Atlanta, GANorthwestern Memorial Hospital· Chicago, IL

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