Clinical Trial

An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

Study acronym: VALE
Active, Not Recruiting Phase 3
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Summary
This study is designed as a long-term extension to Study APL2-C3G-310, and is being conducted to establish the long-term safety and efficacy of pegcetacoplan in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN).
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-03-30; most recent amendment 2026-03-31.
Status change: Not Yet Recruiting → Active, Not Recruiting 2024-03-07
Trial Details
NCT Number NCT05809531
Lead Sponsor Apellis Pharmaceuticals, Inc.
Conditions C3G, IC-MPGN, C3 Glomerulopathy, C3 Glomerulonephritis, Complement 3 Glomerulopathy, Complement 3 Glomerulopathy (C3G), Complement 3 Glomerulonephritis, Dense Deposit Disease +4 more
Enrollment 100 participants
Start Date 2023-05-29
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-04-02