CLINICAL TRIALS PROFILE FOR PEGCETACOPLAN
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All Clinical Trials for pegcetacoplan
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02264639 ↗ | A Phase I Study to Assess the Safety of Pegcetacoplan (APL-2) as an Add-On to Standard of Care in Subjects With PNH | Completed | Apellis Pharmaceuticals, Inc. | Phase 1 | 2015-02-23 | This study will be the initial exploration of pegcetacoplan in patients with PNH. The assessments of the safety, tolerability, PK, and PD following administration of single and multiples doses of pegcetacoplan will guide decisions to further develop the drug. |
| NCT02461771 ↗ | Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal Pegcetacoplan (APL-2) for Patients With Wet AMD | Completed | Apellis Pharmaceuticals, Inc. | Phase 1 | 2015-01-28 | The objective of this study is to provide initial safety, tolerability and pharmacokinetics information of intravitreal administration of pegcetacoplan in order to support further development into larger Phase II studies for treatment of patients with AMD. |
| NCT02503332 ↗ | Study of Pegcetacoplan (APL-2) Therapy in Patients With Geographic Atrophy | Completed | Apellis Pharmaceuticals, Inc. | Phase 2 | 2015-09-24 | The primary objectives of the study are to assess the safety, tolerability and evidence of activity of multiple intravitreal (IVT) injections of pegcetacoplan in subjects with Geographic Atrophy associated with Age-Related Macular Degeneration (AMD). |
| NCT02588833 ↗ | Pilot Study to Assess Safety, Preliminary Efficacy and Pharmacokinetics of S.C. Pegcetacoplan (APL-2) in PNH Subjects. | Completed | Apellis Pharmaceuticals, Inc. | Phase 1 | 2015-12-01 | The objectives of the study are to assess the safety, tolerability, preliminary efficacy and PK of multiple subcutaneous (SC) doses of pegcetacoplan in subjects with paroxysmal nocturnal hemoglobinuria (PNH) who have not received treatment with eculizumab in the past. An exploratory objective of the study is to assess the pharmacodynamics (PD) of multiple SC doses of pegcetacoplan when administered to PNH patients. |
| NCT03465709 ↗ | Pegcetacoplan (APL-2) in Neovascular AMD | Terminated | Apellis Pharmaceuticals, Inc. | Phase 1/Phase 2 | 2018-02-14 | Safety Assessment of Pegcetacoplan in Patients with Neovascular AMD |
| NCT03525600 ↗ | 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 | Active, not recruiting | Apellis Pharmaceuticals, Inc. | Phase 3 | 2018-08-31 | This is a 30-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD. |
| NCT03525613 ↗ | 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 | Active, not recruiting | Apellis Pharmaceuticals, Inc. | Phase 3 | 2018-08-30 | This is a 30-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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