Tests satralizumab in children with aquaporin-4 positive neuromyelitis optica spectrum disorder
Studies how satralizumab moves through the body in children aged 2 to 11 with NMOSD.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Denver, United StatesSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 11 years old?
Source: NCT05199688, who can take part
Where in United States
- Children's Hospital ColoradoDenver, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT05199688EU 2023-507817-85-00
- Record updated
- 1 October 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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:; 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.
Exclusion: Receipt of a live or live-attenuated vaccine within 6 weeks prior to baseline; IVIg or subcutaneous Ig (SCIg) within 4 weeks prior to enrollment/Day 1; 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); History of severe allergic reaction to a biologic agent; Pregnancy or lactation.