Trials / Completed
CompletedNCT05067127
Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 124 (actual)
- Sponsor
- Apellis Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 3 study to assess the efficacy and safety of twice-weekly subcutaneous (SC) doses of pegcetacoplan compared to placebo in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN) on the basis of a reduction in proteinuria.
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 |
| OTHER | Placebo | Sterile solution of equal volume to active arm |
Timeline
- Start date
- 2021-11-12
- Primary completion
- 2024-06-26
- Completion
- 2025-01-14
- First posted
- 2021-10-05
- Last updated
- 2026-01-29
- Results posted
- 2025-08-06
Locations
125 sites across 19 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, France, Germany, Israel, Italy, Japan, Netherlands, Poland, South Korea, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05067127. Inclusion in this directory is not an endorsement.