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)

🧪 Interventions in This Study

• Satralizumab (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Age at screening 2-11 years, inclusive
2. Body weight at screening \>=10 kg
3. 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
4. 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
5. Neurological stability for \>=30 days prior to both screening and baseline
6. Expanded Disability Status Scale (EDSS) 0 to 6.5
7. For patients receiving a baseline immunosuppressant treatment and planning to continue on these therapies, treatment must be at stable dose for 4 weeks prior to baseline

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 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
• 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
• Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD — 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

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.