NCT04155424

A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder

A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients With Relapsing Neuromyelitis Optica Spectrum Disorder

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and efficacy of eculizumab in pediatric participants (aged 2 to \< 18 years) with relapsing neuromyelitis optica spectrum disorder (NMOSD).

Conditions

• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Eculizumab	Following a weight-based weekly dose of eculizumab during an induction phase, participants will receive weight-based doses of eculizumab every 2 weeks during the Primary Treatment Period and Extension Treatment Period.

Timeline

• Start date: 2020-01-14
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2019-11-07
• Last updated: 2024-09-25
• Results posted: 2024-09-25

Locations

35 sites across 7 countries: United States, Canada, Germany, Italy, Japan, South Korea, Spain

Regulatory

• FDA-regulated drug study