NCT05199688

A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)

A Phase III, Multicenter, Open-Label, Uncontrolled Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

This study will primarily evaluate the pharmacokinetics of satralizumab in pediatric patients aged 2-11 years with anti-aquaporin-4 (AQP4) antibody seropositive neuromyelitis optica spectrum disorder (NMOSD). Efficacy, safety, tolerability, and pharmacodynamics will be evaluated in a descriptive manner, given the small number of patients who will be enrolled in this study.

Conditions

• Neuromyelitis Optica Spectrum Disorder
• NMOSD

Interventions

Type	Name	Description
DRUG	Satralizumab	Participants will receive satralizumab treatment for a minimum of 48 weeks and then will have the opportunity to enter an optional satralizumab extension (OSE) period.

Timeline

• Start date: 2026-04-30
• Primary completion: 2027-03-31
• Completion: 2029-09-12
• First posted: 2022-01-20
• Last updated: 2026-04-13

Locations

13 sites across 9 countries: United States, Argentina, China, France, Italy, Mexico, Poland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study