ALXN1210 Versus Eculizumab in Adult Participants with Paroxysmal Nocturnal Hemoglobinuria (PNH) currently Treated With Eculizumab
Study identifier:ALXN1210-PNH-302
ClinicalTrials.gov identifier:NCT03056040
EudraCT identifier:2016-002026-36
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Paroxysmal nocturnal hemoglobinuria (PNH)
Phase
Phase 3
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
202
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 17 May 2017
Primary Completion Date: 08 Apr 2022
Study Completion Date: 08 Apr 2022
Study design
Allocation: N/A
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jun 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 On Day 1, participants received weight-based doses of ravulizumab ranging from 2400 to 3000 milligrams (mg). Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Days 15, 71, and 127. After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants will receive weight-based doses of ravulizumab for up to 4 years. | Biological/Vaccine: Ravulizumab 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. Other Name: ALXN1210 Other Name: ULTOMIRIS |
| Active Comparator: Eculizumab Participants received 900 mg of eculizumab every 2 weeks (q2w) for 26 weeks. After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants will receive weight-based doses of ravulizumab for up to 4 years. | Biological/Vaccine: Ravulizumab 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. Other Name: ALXN1210 Other Name: ULTOMIRIS Biological/Vaccine: Eculizumab All treatments were given as IV infusions. Participants received 900 mg of eculizumab q2w. |
