Satralizumab for Pediatric NMOSD (Aquaporin-4 Antibody Positive)
This study is looking at a medicine called satralizumab for children aged 2 to 11 years old who have neuromyelitis optica spectrum disorder (NMOSD) that is aquaporin-4 (AQP4) antibody positive. NMOSD is a rare, lifelong autoimmune disease that affects the central nervous system. The main goal is to understand how the body processes satralizumab in these children. Researchers will also look at how well satralizumab works, its safety, and how well children tolerate it. Only a small number of children (8) will be included in this study. Participants will receive satralizumab for at least 48 weeks, with an option to continue longer.
- Study design
- This is an interventional study planning to enroll 8 participants. It is not specified if it is randomized, blinded, or its phase.
- What's involved
- Participants will receive satralizumab treatment for a minimum of 48 weeks and then have the opportunity to enter an optional extension period.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for measuring satralizumab levels are at Week 48. It is not specified how long participants are followed after the optional extension period.
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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)
At a glance
Conditions
Where it's being run
13 sites across 11 statesStudy leadership
- Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche
Who to contact
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Inclusion
Exclusion
What this trial measures
- Summary of observed serum concentration [Cthrough] of satralizumabWeek 48
- Apparent clearance [CL/F] of satralizumabWeek 48
- Apparent volume of distribution [V/F] of satralizumabWeek 48
- Area under the concentration-time curve [AUC] of satralizumabWeek 48