NCT04201262

An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD

A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for the treatment of adult participants with NMOSD.

Conditions

• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorder

Interventions

Type	Name	Description
BIOLOGICAL	Ravulizumab	Participants will receive a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until end of the Long-Term Extension Period.

Timeline

• Start date: 2019-12-09
• Primary completion: 2022-03-15
• Completion: 2024-10-31
• First posted: 2019-12-17
• Last updated: 2025-10-14
• Results posted: 2023-08-09

Locations

41 sites across 13 countries: United States, Australia, Austria, Canada, Denmark, France, Germany, Italy, Japan, Poland, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study