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NCT05809531Phase 3ACTIVE NOT RECRUITING

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 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).

Conditions
C3GIC-MPGNC3 GlomerulopathyC3 GlomerulonephritisComplement 3 GlomerulopathyComplement 3 Glomerulopathy (C3G)Complement 3 GlomerulonephritisDense Deposit DiseaseDDDMembranoproliferative GlomerulonephritisMembranoproliferative Glomerulonephritis (MPGN)Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
Interventions / Drugs
Pegcetacoplan
View on ClinicalTrials.gov ↗
Sponsor
APLS
Apellis Pharmaceuticals
Complement Inhibitors
D37/100
Study Details
Enrollment100 participants
Primary Completion—
Lead SponsorApellis Pharmaceuticals, Inc.
Data Retrieved2026-04-11 02:54:08.046044+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 100 participants
Sponsor Catalyst Profile

Apellis Pharmaceuticals (APLS) is the sponsoring company for this trial. BiotechSign currently grades this company D (37/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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