Trials / Completed
CompletedNCT02946463
ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 272 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who had never been treated with a complement inhibitor (treatment-naïve).
Detailed description
The study consisted of a 4-week screening period and a 26-week randomized treatment period (Primary Evaluation Period). After completion of the 26-week Primary Evaluation Period, all participants had the opportunity to enter the Extension Period, wherein participants will receive ravulizumab for up to 5 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ravulizumab | All treatments were given as intravenous (IV) infusions. For participants weighing ≥40 to \<60 kilogram (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. |
| BIOLOGICAL | Eculizumab | All treatments were given as IV infusions. Participants were administered induction doses of 600 mg followed by maintenance doses of 900 mg. |
Timeline
- Start date
- 2016-12-12
- Primary completion
- 2023-02-28
- Completion
- 2023-02-28
- First posted
- 2016-10-27
- Last updated
- 2024-05-14
- Results posted
- 2019-02-12
Locations
120 sites across 26 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Estonia, France, Germany, Italy, Japan, Malaysia, Mexico, Poland, Russia, Serbia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02946463. Inclusion in this directory is not an endorsement.