CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 139 enrolled
Drug / intervention
Ravulizumab OBDS +1 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03748823
NCT03748823Phase 3Completed
CompareCT.gov

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

Alexion Pharmaceuticals, Inc.·interventional·Posted Nov 21, 2018·Updated Sep 19, 2024

In Brief

A Phase 3 clinical trial evaluating Ravulizumab OBDS and Ravulizumab for Paroxysmal Nocturnal Hemoglobinuria. Completed, enrolled 139 participants across 51 sites in 14 countries.

Detailed Summary

The primary objective of this study is to evaluate pharmacokinetics (PK) of ravulizumab administered subcutaneously via an on-body delivery system (OBDS) compared with intravenously administered ravulizumab in adult participants with PNH who are clinically stable on eculizumab for at least 3 months prior to study entry.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Nocturnal Hemoglobinuria
CountriesAustralia, Austria, Belgium, Brazil, Canada, Finland, France, Italy, Netherlands, Russia, Spain, Sweden, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedNov 21, 2018
Enrollment StartFeb 19, 2019
Primary CompletionFeb 2, 2021
Study CompletionAug 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.6 years ago

Interventions

Ravulizumab OBDScombination

The ravulizumab OBDS is a biological-device combination product consisting of a prefilled cartridge containing ravulizumab SC and an on-body injector.

Ravulizumabbiological

Administered by IV infusion. Ravulizumab IV doses will be based on participant body weight.