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APL-2

DRUG6 trials

Sponsors

Apellis Pharmaceuticals Inc., Apellis Pharmaceuticals, Inc.

Conditions

C3 GlomerulonephritisCold Agglutinin DiseaseDense Deposit DiseaseGeographic AtrophyGeographic Atrophy Secondary to Age-Related Macular DegenerationIgA NephropathyLupus NephritisMembranous Nephropathy

Phase 2

Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)
CompletedNCT03226678
Apellis Pharmaceuticals, Inc.Cold Agglutinin Disease, Warm Autoimmune Hemolytic Anemia
Start: 2017-08-31End: 2022-09-12Updated: 2024-12-12
Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies
CompletedNCT03453619
Apellis Pharmaceuticals, Inc.C3 Glomerulonephritis, Dense Deposit Disease, IgA Nephropathy +2
Start: 2018-02-26End: 2023-08-26Updated: 2025-02-13

Phase 3

Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration
CompletedNCT03525600
Apellis Pharmaceuticals, Inc.Geographic Atrophy
Start: 2018-08-31End: 2022-06-20Updated: 2023-06-18
A Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration
CompletedNCT03525613
Apellis Pharmaceuticals, Inc.Geographic Atrophy
Start: 2018-08-31End: 2022-06-28Updated: 2023-07-06
A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With PNH
CompletedNCT04085601
Apellis Pharmaceuticals, Inc.Paroxysmal Nocturnal Hemoglobinuria
Start: 2019-08-27End: 2021-06-23Updated: 2022-10-21
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
CompletedCTIS2024-512945-18-00
Apellis Pharmaceuticals Inc.Geographic Atrophy Secondary to Age-Related Macular Degeneration
Start: 2021-11-30End: 2025-06-05Target: 206Updated: 2025-04-24

Related Papers

Exploring Trial Endpoints in Geographic Atrophy Based on Localized Functional Changes in Microperimetry and AI-Quantified OCT Biomarkers.
2026-01-01
Consistent benefits of pegcetacoplan treatment in PNH patients with and without a history of aplastic anemia in real world: Analysis of the ongoing COMPLETE Phase IV observational study
Blood2025-11-03
Real-world clinical characteristics and treatment outcomes in PNH patients prescribed pegcetacoplan across europe, the United States and Canada
Blood2025-11-03
Efficacy of Intravitreal Pegcetacoplan vs Avacincaptad Pegol in Patients With Geographic Atrophy.
2025-10-17
Dynamics of the EZ/RPE Loss Ratio on OCT Over Time During Geographic Atrophy Progression and Treatment With Pegcetacoplan.
2025-08-01
Efficacy and Safety Maintained up to 3 Years in Adults with Paroxysmal Nocturnal Hemoglobinuria Receiving Pegcetacoplan.
2025-07-28
Outer Retinal Tubulation and Geographic Atrophy: A Natural History Analysis of Sham Observed Eyes from the OAKS and DERBY Trials.
2025-05-19
Pegcetacoplan Treatment for Geographic Atrophy in Age-Related Macular Degeneration Over 36 Months: Data From OAKS, DERBY, and GALE.
2025-04-233 citations
Pharmacokinetic/pharmacodynamic analysis of geographic atrophy lesion area in patients receiving pegcetacoplan treatment or sham
CPT Pharmacometrics & Systems Pharmacology2024-11-052 citations
Safety and efficacy of pegcetacoplan treatment for cold agglutinin disease and warm antibody autoimmune hemolytic anemia
Blood2024-11-0113 citations
Efficacy and Safety of Pegcetacoplan in Kidney Transplant Recipients With Recurrent Complement 3 Glomerulopathy or Primary Immune Complex Membranoproliferative Glomerulonephritis.
2024-10-1020 citations
Moving toward Individual Treatment Goals with Pegcetacoplan in Patients with PNH and Impaired Bone Marrow Function
International Journal of Molecular Sciences2024-08-063 citations
Improvements in hematologic markers and decreases in fatigue with pegcetacoplan for patients with paroxysmal nocturnal hemoglobinuria and mild or moderate anemia (hemoglobin ≥10 g/dL) who had received eculizumab or were naive to complement inhibitors
PLoS ONE2024-07-291 citations
Pegcetacoplan Treatment and Consensus Features of Geographic Atrophy Over 24 Months.
2024-06-0111 citations
Normalization of Hemoglobin, Lactate Dehydrogenase, and Fatigue in Patients with Paroxysmal Nocturnal Hemoglobinuria Treated with Pegcetacoplan
Drugs in R&D2024-05-101 citations
Management of acute breakthrough hemolysis with intensive pegcetacoplan dosing in patients with PNH
Blood Advances2024-02-0530 citations
Efficacy and Safety Is Maintained in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria Receiving Pegcetacoplan for up to 3 Years
Blood2023-11-027 citations
Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials.
2023-10-01298 citations
Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy
Kidney International Reports2023-09-2274 citations
Evaluating the Effects of C3 Inhibition on Geographic Atrophy Progression from Deep-Learning OCT Quantification: A Split-Person Study.
2023-09-16

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