Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD
Condition(s) studied
Investigational drug(s) / intervention(s)
Ravulizumab: Participants will receive a weight-based loading dose of ravulizumab on Day 1, followed by weight-based maintenance treatment with ravulizumab on Day 15 and every 8 weeks (q8w) after or once every 4 weeks (q4w) depending on weight. During the Extension Period, participants will continue to receive weight-based maintenance doses of ravulizumab IV on Day 351 and q8w or q4w, depending on weight.
Study summary
The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab in pediatric participants with Neuromyelitis Optica Spectrum Disorder (NMOSD).
Eligibility
Primary outcome measure(s)
- Change From Baseline in the Annualized Relapse Rate at Week 50 — Baseline, Week 50
- Time to First Adjudicated On-trial Relapse through Week 50 — Baseline through Week 50
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Washington D.C. | District of Columbia | |
| Research Site | Miami | Florida | |
| Research Site | Boston | Massachusetts | |
| Research Site | Durham | North Carolina | |
| Research Site | Philadelphia | Pennsylvania | |
| Research Site | Edmonton | Alberta | |
| Research Site | Toronto | Ontario | |
| Research Site | Montreal | Quebec | |
| Research Site | Le Kremlin-Bicêtre | France | |
| Research Site | Marseille | France | |
| Research Site | Chieti | Italy | |
| Research Site | Gallarate | Italy | |
| Research Site | Roma | Italy | |
| Research Site | Yokohama | Japan | |
| Research Site | Goyang-si | South Korea | |
| Research Site | Esplugues de Llobregat | Spain |
On this site
📄 Ultomiris (ravulizumab) drug profile →More Alexion Pharmaceuticals, Inc. trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05346354 on ClinicalTrials.gov ↗ ← All trials in South Korea