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)
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Summary of Observed Serum Concentration of Satralizumab — Week 48
- Apparent Clearance [CL/F] of Satralizumab — Week 48
- Apparent Volume of Distribution [V/F] of Satralizumab — Week 48
- Area Under the Concentration-time Curve [AUC] of Satralizumab — Week 48
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| Children's Hospital Colorado. | Denver | Colorado | Recruiting |
| Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan | Ciudad Autonoma Buenos Aires | Argentina | Recruiting |
| Clinica Universitaria Reina Fabiola | Córdoba | Argentina | Recruiting |
| Guangzhou Women and Children's Medical Center | Guangzhou | Guangdong | Recruiting |
| Children's Hospital of Fudan University | Shanghai | Shanghai Municipality | Recruiting |
| Centre Hospitalier Universitaire de Bicêtre | Le Kremlin-Bicêtre | Val-de-Marne | Recruiting |
| IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN | Rome | Lazio | Recruiting |
| Fondazione Istituto Neurologico Mondino IRCCS | Pavia | Lombardy | Recruiting |
| Grupo Medico Camino | DF | Mexico CITY (federal District) | Recruiting |
| Hospital Infantil de Mexico Federico Gomez | Mexico City | Mexico CITY (federal District) | Recruiting |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | Active Not Recruiting |
| Instytut "Pomnik - Centrum Zdrowia Dziecka" | Warsaw | Poland | Recruiting |
| Kocaeli University Research and Application Hospit | Kocaeli | Turkey (Türkiye) | Recruiting |
| Great Ormond Street Hospital for Children | London | United Kingdom | Recruiting |
More Hoffmann-La Roche trials in the UK
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 NCT05199688 on ClinicalTrials.gov ↗ ← All trials in the UK