Satralizumab
DrugParticipants will receive satralizumab treatment for a minimum of 48 weeks and then will have the opportunity to enter an optional satralizumab extension (OSE) period.
NCT Number: NCT05199688
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.
Interested in participating?
Request Info2 year–11 year
All sexes
Interventional
Phase 3
Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan, Ciudad Autonoma Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive satralizumab treatment for a minimum of 48 weeks and then will have the opportunity to enter an optional satralizumab extension (OSE) period.
Time frame: Week 48
Time frame: Week 48
Time frame: Week 48
Time frame: Week 48
Time frame: Week 48
Time frame: Week 48
Time frame: Week 48
Time frame: Week 48
Time frame: Baseline, Week 24, Week 48
Time frame: Baseline, Week 24, Week 48
Time frame: Baseline, Week 24, Week 48
Time frame: Baseline, Week 24, Week 48
Time frame: Week 48
Contact information is provided by the study sponsor or research team.
Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
Reference Study ID Number: WN41733 https://forpatients.roche.com/
CONTACT
888-662-6728 (U.S.)
Hoffmann-La Roche
Industry
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)
Acronym: SAkuraSun
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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