drugset / Trial / NCT02605993

Open-label, Multiple Ascending Dose Study of Ravulizumab (ALXN1210) in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

NCT02605993

Phase 2 Completed 26 enrolled Alexion Pharmaceuticals, Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of multiple intravenous (IV) doses of ravulizumab administered to complement inhibitor treatment-naïve participants with PNH.

Timeline

Start
2016-01-04
Primary completion
2017-02-23
Completion
2022-01-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ravulizumab Monoclonal antibody 1000 mg Intravenous
Subject Ravulizumab Monoclonal antibody 1600 mg Intravenous
Subject Ravulizumab Monoclonal antibody 2400 mg Intravenous
Subject Ravulizumab Monoclonal antibody 5400 mg Intravenous