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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

NCT05809531 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-02

No results posted yet for this 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

  • C3G
  • IC-MPGN
  • C3 Glomerulopathy
  • C3 Glomerulonephritis
  • Complement 3 Glomerulopathy
  • Complement 3 Glomerulopathy (C3G)
  • Complement 3 Glomerulonephritis
  • Dense Deposit Disease
  • DDD
  • Membranoproliferative Glomerulonephritis
  • Membranoproliferative Glomerulonephritis (MPGN)
  • Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)

Interventions

DRUG

Pegcetacoplan

Complement (C3) Inhibitor

Sponsors & Collaborators

  • Apellis Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-29
Primary Completion
2027-07-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Czechia
  • France
  • Israel
  • Italy
  • Japan
  • Netherlands
  • South Korea
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05809531 on ClinicalTrials.gov