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NCT05199688 · ClinicalTrials.gov record · last posted 2026-08-11

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)

Study acronym: SAkuraSun
StatusRecruiting
PhasePhase 3
Started2026-05-06
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 56 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 56 times since 2022-01-05; most recent amendment 2026-07-08. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2022-07-21
Status change Not Yet Recruiting→Recruitingv7
Trial Details
NCT Number NCT05199688
Lead Sponsor Hoffmann-La Roche
Conditions Neuromyelitis Optica Spectrum Disorder, NMOSD
Enrollment 8 participants
Start Date 2026-05-06
Primary Completion 2027-03-31 (estimated)
Study Completion 2029-09-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-11