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A Sequential Phase 2/3 Study of APL2 in Patients With Focal Segmental Glomerulosclerosis

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment resumed after suspension Site details revised at 2 of 2 sitesv3 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  2. Trial status: Not Yet Recruiting to Suspended Sponsor's reason: Study temporarily suspended due to company acquisition and ongoing strategic evaluation, with recruitment challenges including screening… Start date: Dec 2025 to Dec 2026v2 Show 1 more changeShow less
    • Start date: Dec 2025 to Dec 2026
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a sequential phase 2/3 study to evaluate the efficacy and safety of twice-weekly subcutaneous (SC) infusions of APL2 in patients diagnosed with FSGS. The initial phase 2 portion is a single-arm, open-label study in adults diagnosed with FSGS. Phase 2 will commence prior to randomizing for phase 3. The phase 3 portion of the study is a randomized, placebo-controlled, double-blinded, multicenter study in adults and adolescents diagnosed with FSGS.
Trial Details
NCT Number NCT07213960
Lead Sponsor Apellis Pharmaceuticals, Inc.
Conditions FSGS
Enrollment 270 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov