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)
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.
Eligibility
- Age range
- 2–11 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age at screening 2-11 years, inclusive * Body weight at screening \>=10 kg * For female patients of childbearing potential (postmenarchal): agreement to either remain completely abstinent (refrain from heterosexual intercourse) or to use a reliable means of contraception * Diagnosed as having NMOSD with AQP4 antibody seropositive status as defined by the Wingerchuk 2015 criteria Clinical evidence of at least one documented attack (including first attack) in the last year prior to screening * Neurological stability for \>=30 days prior to both screening and baseline * Exp…
Interventions
- DrugSatralizumab
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 (13)
- Children's Hospital Colorado.Denver, Colorado
- Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. GarrahanCiudad Autonoma Buenos Aires
- Clinica Universitaria Reina FabiolaCórdoba
- Guangzhou Women and Children's Medical CenterGuangzhou, Guangdong
- Children's Hospital of Fudan UniversityShanghai, Shanghai Municipality
- Centre Hospitalier Universitaire de BicêtreLe Kremlin-Bicêtre