Last updated 18 days ago
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)
8 patients around the world
Available in Argentina
Hoffmann-La Roche
2Research sites
8Patients around the world
This study is for people with
Neuromyelitis optica
Requirements for the patient
To 11 Years
All Gender
Medical requirements
- Age at screening 2-11 years, inclusiveBody weight at screening >=10 kgFor female patients of childbearing potential (postmenarchal): agreement to either remain completely abstinent (refrain from heterosexual intercourse) or to use a reliable means of contraceptionDiagnosed 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 screeningNeurological stability for >=30 days prior to both screening and baselineExpanded Disability Status Scale (EDSS) 0 to 6.5For patients receiving a baseline immunosuppressant treatment and planning to continue on these therapies, treatment must be at stable dose for 4 weeks prior to baseline
- Pregnancy or lactationEvidence of other demyelinating disease mimicking NMOSDActive or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baselineEvidence of chronic active hepatitis B or CEvidence of untreated latent or active tuberculosis (TB)Receipt of a live or live-attenuated vaccine within 6 weeks prior to baselineHistory of severe allergic reaction to a biologic agent
Sites
Clínica Universitaria Privada Reina Fabiola - Córdoba
Recruiting
Hospital de Pediatría Dr. Juan P. Garrahan
Recruiting
StudySAkuraSun
SponsorHoffmann-La Roche
Conditions
Neuromyelitis optica
Requirements
To 11 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05199688
