NCT03500549

Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Apellis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria

Conditions

• Paroxysmal Nocturnal Hemoglobinuria

Interventions

Type	Name	Description
DRUG	Pegcetacoplan	Complement (C3) Inhibitor
DRUG	Soliris	Complement (C5) Inhibitor

Timeline

• Start date: 2018-06-14
• Primary completion: 2019-11-14
• Completion: 2020-08-13
• First posted: 2018-04-18
• Last updated: 2022-03-25
• Results posted: 2022-03-25

Locations

53 sites across 11 countries: United States, Australia, Belgium, Canada, France, Germany, Japan, Russia, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study