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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

Study acronym: RESULT
StatusRecruiting
PhasePhase 2
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 71 → 75 locations
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 3 of 5 entries
    • Publications: details revised at 1 of 1 entry
  2. Eligibility criteria expanded, about 23 wordsv29
  3. Study sites: 69 to 71v28
  4. Study sites revised (69)v27
  5. Study sites revised (69)v26
Show 24 earlier versionsHide 24 earlier versions
  1. Study sites: 70 to 69v25
  2. Study sites: 67 to 70v24
  3. Study sites: 63 to 67v23
  4. Eligibility criteria expanded, about 31 wordsv22
  5. Study sites: 62 to 63v21
  6. Study sites: 61 to 62v20
  7. Interventions: SAR442970 (Drug), frexalimab (Drug), placebo (Drug), rilzabrutinib (Drug) to brivekimig (Drug), frexalimab (Drug), placebo (Drug), rilzabrutinib (Drug)
    • Eligibility criteria expanded, about 24 words
    • Study sites revised (61)
    • Study title revised
    v19
  8. Study sites: 58 to 61v18
  9. Study sites revised (58)v17
  10. Study sites: 55 to 58v16
  11. Study sites: 54 to 55v15
  12. Study sites: 52 to 54v14
  13. Study sites: 46 to 52v13
  14. Study sites: 43 to 46v12
  15. Study sites: 39 to 43v11
  16. Study sites: 35 to 39v10
  17. Study sites: 30 to 35v9
  18. Study sites: 24 to 30v8
  19. Study sites: 17 to 24v7
  20. Study sites: 12 to 17v6
  21. Study sites: 4 to 12v5
  22. Start date: Aug 22, 2024 to Dec 19, 2024
    • Study sites: 3 to 4
    v4
  23. Study sites: 1 to 3v3
  24. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 4, 2024 to Aug 22, 2024
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
284 trials monitored
See 12 trials at risk
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.
Trial Details
NCT Number NCT06500702
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion
Related terms Glomerulosclerosis, Focal Segmental, Nephrosis, Lipoid
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov