Trials / Active Not Recruiting
Active Not RecruitingNCT05809531
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
An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Apellis Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Pegcetacoplan | Complement (C3) Inhibitor |
Timeline
- Start date
- 2023-05-29
- Primary completion
- 2027-07-01
- Completion
- 2027-07-01
- First posted
- 2023-04-12
- Last updated
- 2026-04-02
Locations
47 sites across 15 countries: United States, Argentina, Australia, Belgium, Brazil, Czechia, France, Israel, Italy, Japan, Netherlands, South Korea, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05809531. Inclusion in this directory is not an endorsement.