Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
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
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