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) (NCT05199688)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital Colorado. — Denver, Colorado
Age range: 2 Years to 11 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (13 Sites)
- Children's Hospital Colorado. — Denver, Colorado
- Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan — Ciudad Autonoma Buenos Aires,
- Clinica Universitaria Reina Fabiola — Córdoba,
- Guangzhou Women and Children's Medical Center — Guangzhou, Guangdong
- Children's Hospital of Fudan University — Shanghai, Shanghai Municipality
- Centre Hospitalier Universitaire de Bicêtre — Le Kremlin-Bicêtre, Val-de-Marne
- IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN — Rome, Lazio
- Fondazione Istituto Neurologico Mondino IRCCS — Pavia, Lombardy
- Grupo Medico Camino — DF, Mexico CITY (federal District)
- Uniwersyteckie Centrum Kliniczne — Gda?sk,
- Instytut "Pomnik - Centrum Zdrowia Dziecka" — Warsaw,
- Kocaeli University Research and Application Hospit — Kocaeli,
- Great Ormond Street Hospital for Children — London,
📞 Contact the Study Coordinator
Phone: (888) 662-6728
Email: global-roche-genentech-trials@gene.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Neuromyelitis Optica Spectrum Disorder
- Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD) — Detroit, Michigan
- Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD — Washington D.C., District of Columbia
- Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy — Aurora, Colorado
- Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies — Washington D.C., District of Columbia
- Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder — La Jolla, California
Explore by condition: All Neuromyelitis Optica Spectrum Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.