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)
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:
* Documented history of a positive anti-AQP4 antibody test or a positive anti-AQP4 antibody test at screening;
Neurological stability for \>=30 days prior to baseline
Expanded Disability Status Scale (EDSS) 0 to 6.5
For participants receiving a baseline immunosuppressant treatment and planning to continue on these therapies, treatment must be at stable dose for 4 weeks prior to baseline
You may not be if
Pregnancy or lactation
Evidence of other demyelinating disease mimicking NMOSD
Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
Evidence of chronic active hepatitis B or C
Evidence of untreated latent or active tuberculosis (TB)
Receipt of a live or live-attenuated vaccine within 6 weeks prior to baseline
History of severe allergic reaction to a biologic agent
IVIg or subcutaneous Ig (SCIg) within 4 weeks prior to enrollment/Day 1
Clareo Health | 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)
