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RECRUITING
NCT05199688
PHASE3

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)

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

2 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2026-03-31

Completion Date

2029-09-12

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

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.

Locations (12)

Children's Hospital Colorado.

Denver, Colorado, United States

Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan

Ciudad Autonoma Buenos Aires, Argentina

Clinica Universitaria Reina Fabiola

Córdoba, Argentina

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Centre Hospitalier Universitaire de Bicêtre

Le Kremlin-Bicêtre, France

IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

Rome, Lazio, Italy

Fondazione Istituto Neurologico Mondino IRCCS

Pavia, Lombardy, Italy

Grupo Medico Camino

DF, Mexico CITY (federal District), Mexico

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Instytut "Pomnik - Centrum Zdrowia Dziecka"

Warsaw, Poland

Kocaeli University Research and Application Hospit

Kocaeli, Turkey (Türkiye)

Great Ormond Street Hospital for Children

London, United Kingdom