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Study identifier: NCT05199688 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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: Neuromyelitis Optica Spectrum Disorder · NMOSD  ·  Sponsor: Hoffmann-La Roche

PhasePhase 3
Planned participants8
Who can joinAll sexes, 2 Years to 11 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Reference Study ID Number: WN41733 https://forpatients.roche.com/  ·  888-662-6728 (U.S.)  ·  global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry  ·  global.medical_information@roche.com

Always discuss trial participation with your own doctor first.

Locations (13)

Children's Hospital Colorado.Denver, Colorado, United StatesRecruiting
Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. GarrahanCiudad Autonoma Buenos Aires, ArgentinaRecruiting
Clinica Universitaria Reina FabiolaCórdoba, ArgentinaRecruiting
Guangzhou Women and Children's Medical CenterGuangzhou, Guangdong, ChinaRecruiting
Children's Hospital of Fudan UniversityShanghai, Shanghai Municipality, ChinaRecruiting
Centre Hospitalier Universitaire de BicêtreLe Kremlin-Bicêtre, FranceRecruiting
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PINRome, Lazio, ItalyRecruiting
Fondazione Istituto Neurologico Mondino IRCCSPavia, Lombardy, ItalyRecruiting
Grupo Medico CaminoDF, Mexico CITY (federal District), MexicoRecruiting
Uniwersyteckie Centrum KliniczneGdansk, PolandActive Not Recruiting
Instytut "Pomnik - Centrum Zdrowia Dziecka"Warsaw, PolandRecruiting
Kocaeli University Research and Application HospitKocaeli, Turkey (Türkiye)Recruiting

+ 1 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05199688