Ravulizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With High-Dose Eculizumab

PHASE4CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

April 14, 2021

Primary Completion Date

December 20, 2022

Study Completion Date

December 20, 2022

Conditions
Paroxysmal Nocturnal Hemoglobinuria
Interventions
BIOLOGICAL

Eculizumab

Participants must have been prescribed and be receiving a stable dose of eculizumab 1200 milligrams (mg) every 2 weeks (q2w) for at least 3 months prior to the Screening Period. During the Screening Period, participants will continue to receive eculizumab 1200 mg q2w.

BIOLOGICAL

Ravulizumab

During the Treatment Period, participants will receive a loading dose of ravulizumab on Day 1, followed by maintenance doses on Day 15 and every 8 weeks, administered by intravenous infusion. Ravulizumab loading and maintenance doses will be based on participants' body weight per approved dose regimen.

Trial Locations (4)

LS9 7TF

Clinical Study Site, Leeds

Research Site, Leeds

SE5 9RS

Clinical Study Site, London

Research Site, London

Sponsors
All Listed Sponsors
lead

Alexion Pharmaceuticals, Inc.

INDUSTRY