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)
Start Date
5/6/2026
Completion Date
9/12/2029
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 Criteria
Age Range: 2 years to 11 years
Interventions
Satralizumab
Conditions
Locations
Children's Hospital Colorado.
Denver, Colorado 80218-1007
United States
Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan
Ciudad Autonoma Buenos Aires, C1249ABN
Argentina
Clinica Universitaria Reina Fabiola
Córdoba, X5004FHP
Argentina
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong 510120
China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality 201102
China
Centre Hospitalier Universitaire de Bicêtre
Le Kremlin-Bicêtre, 94275
France
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Rome, Lazio 00165
Italy
Fondazione Istituto Neurologico Mondino IRCCS
Pavia, Lombardy 27100
Italy
Grupo Medico Camino
DF, Mexico CITY (federal District) DUMMY_VALUE
Mexico
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Poland
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warsaw, 04-730
Poland
Kocaeli University Research and Application Hospit
Kocaeli, 6810
Turkey (Türkiye)
Great Ormond Street Hospital for Children
London, WC1N 3JH
United Kingdom