pegcetacoplan
pegcetacoplan: developed by 1 company · 12 clinical trials tracked.
pegcetacoplan evidence translation
What we can confirm
12 tracked trials
What it means
What to watch
Prepared research question
How could pegcetacoplan → APLS affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 1 study sponsors
Related indications
Study sponsors
Development Pipeline (4)
| Company | Phase |
|---|---|
| Apellis Pharmaceuticals, Inc. (APLS) | Approved |
| Apellis Pharmaceuticals, Inc. (APLS) | Phase 3 |
| Apellis Pharmaceuticals, Inc. (APLS) Geographic atrophy secondary to age-related macular degenera… | Approved |
| Apellis Pharmaceuticals, Inc. (APLS) | Phase 3 |
Clinical Trials (12)showing 10 most recent
US Early Access Program for the Treatment of Patients With C3 Glomerulopathy or Primary Immune-Complex Membranoproliferative Glomerulonephritis With Pegcetacoplan
A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation
Primary endpoint: Time to freedom from dialysis through Day 90
Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of ABBV-6628 in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Primary endpoint: Number of Participants Experiencing Adverse Events
A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Primary endpoint: Incidence of ocular AEs in treated eyes overall and according to physician-directed treatment interval based on US prescribing information
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
Primary endpoint: Proportion of participants with a reduction in urine protein-to-creatinine ratio (uPCR) of at least 50% from the pretreatment value over time.
An Open-label, Single-arm, Multicenter Pilot Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Pegcetacoplan in Patients With Transplant-associated Thrombotic Microangiopathy (TA-TMA) After Hematopoietic Stem Cell Transplantation (HSCT)
Primary endpoint: Pegcetacoplan Pharmacokinetic (PK) Parameter Area Under the Curve Limited to the End of Dosing Interval (AUC0-tau)
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
Primary endpoint: Randomized Controlled Period: Change From Baseline in Log-Transformed Urine Protein-to-Creatinine Ratio (uPCR) at Week 26
An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrence of C3G or IC-MPGN
Primary endpoint: Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 12
A Phase 3, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Primary endpoint: Incidence and severity of ocular and systemic adverse events
An Open Label, Single-Arm, Phase 2 Study to Evaluate the Safety, Pharmacokinetics, and Biologic Activity of Pegcetacoplan in Pediatric Patients With Paroxysmal Nocturnal Hemoglobinuria
Primary endpoint: Pegcetacoplan serum concentrations over the course of the 16-week treatment period
Frequently asked questions
Who is developing pegcetacoplan?
pegcetacoplan is being developed by Apellis Pharmaceuticals, Inc..
How many clinical trials involve pegcetacoplan?
BioSniper tracks 12 clinical trials involving pegcetacoplan.