Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Eculizumab
Study identifier:ALXN1210-PNH-303
ClinicalTrials.gov identifier:NCT03748823
EudraCT identifier:2017-002370-39
CTIS identifier:N/A
Study Complete
Official Title
A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label, Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab
Medical condition
paroxysmal nocturnal hemoglobinuria
Phase
Phase 3
Healthy volunteers
No
Study drug
Ravulizumab OBDS
Sex
All
Actual Enrollment
139
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 19 Feb 2019
Primary Completion Date: 02 Feb 2021
Study Completion Date: 31 Aug 2023
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2024 by Alexion Pharmaceuticals, Inc.
Sponsors
Alexion Pharmaceuticals, Inc.
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ravulizumab SC Treatment Group In the Randomized Treatment Period, participants will receive an IV loading dose of ravulizumab on Day 1 followed by SC maintenance doses of ravulizumab administered via the ravulizumab OBDS on Day 15 and every week (qw) thereafter for a total of 10 weeks of study treatment. In the Extension Period, ravulizumab SC will be administered via the ravulizumab OBDS from Day 71 qw through Day 1274. | Combination Product: Ravulizumab OBDS The ravulizumab OBDS is a biological-device combination product consisting of a prefilled cartridge containing ravulizumab SC and an on-body injector. Biological/Vaccine: Ravulizumab Administered by IV infusion. Ravulizumab IV doses will be based on participant body weight. Other Name: ALXN1210 |
| Active Comparator: Ravulizumab IV Treatment Group In the Randomized Treatment Period, participants will receive an IV loading dose of ravulizumab on Day 1 followed by IV maintenance doses of ravulizumab on Day 15. In the Extension Period, ravulizumab SC will be administered via the ravulizumab OBDS from Day 71 qw through Day 1274. | Combination Product: Ravulizumab OBDS The ravulizumab OBDS is a biological-device combination product consisting of a prefilled cartridge containing ravulizumab SC and an on-body injector. Biological/Vaccine: Ravulizumab Administered by IV infusion. Ravulizumab IV doses will be based on participant body weight. Other Name: ALXN1210 |
