CLINICAL TRIALS PROFILE FOR PEGCETACOPLAN

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.

Clinical Trial Conditions for pegcetacoplan

Condition Name

Condition Name for pegcetacoplan
Intervention	Trials
C3G	3
Geographic Atrophy	3
IC-MPGN	3
Complement 3 Glomerulopathy	3

Condition MeSH

Condition MeSH for pegcetacoplan
Intervention	Trials
Hemoglobinuria, Paroxysmal	6
Hemoglobinuria	6
Macular Degeneration	5
Geographic Atrophy	4

Clinical Trial Locations for pegcetacoplan

Trials by Country

Trials by Country for pegcetacoplan
Location	Trials
United States	124
Australia	17
Spain	7
New Zealand	6
Japan	6

Trials by US State

Trials by US State for pegcetacoplan
Location	Trials
California	11
Florida	8
Georgia	7
Maryland	7
Texas	6

Clinical Trial Progress for pegcetacoplan

Clinical Trial Phase

Clinical Trial Phase for pegcetacoplan
Clinical Trial Phase	Trials
Phase 3	8
Phase 2	7
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for pegcetacoplan
Clinical Trial Phase	Trials
Recruiting	5
Completed	5
Active, not recruiting	4

Clinical Trial Sponsors for pegcetacoplan

Sponsor Name

Sponsor Name for pegcetacoplan
Sponsor	Trials
Apellis Pharmaceuticals, Inc.	17
Swedish Orphan Biovitrum	2
National Cancer Institute (NCI)	1

Sponsor Type

Sponsor Type for pegcetacoplan
Sponsor	Trials
Industry	19
NIH	1
Other	1