At a glance
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A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
In Brief
A Phase 3 clinical trial evaluating Ravulizumab and Eculizumab for Paroxysmal Nocturnal Hemoglobinuria (PNH). Completed, enrolled 202 participants across 51 sites in 11 countries.
Detailed Summary
The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who were clinically stable after having been treated with eculizumab for at least 6 months.
Study Details
Timeline
Interventions
All treatments were given as intravenous (IV) infusions. For participants weighing ≥40 to \<60 kilograms (kg): 2400 mg was given as a single loading dose, followed by 3000 mg as maintenance dose. For participants weighing ≥60 to \<100 kg: 2700 mg was given as a loading dose, followed by 3300 mg as maintenance dose. For participants weighing ≥100 kg: 3000 mg was given as a loading dose, followed by 3600 mg as maintenance dose.
All treatments were given as IV infusions. Participants received 900 mg of eculizumab q2w.