Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder (NCT05549258)
An Open-Label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder
🩺 Plain-English Summary (8th-Grade Level)
A Phase 2, open-label, multicenter study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of inebilizumab in eligible pediatric participants 2 to \< 18 years of age with recently active neuromyelitis optica spectrum disorder (NMOSD) who are seropositive for autoantibodies against aquaporin-4 (AQP4-immunoglobulin \[Ig\]G).
Who can join: Review the eligibility criteria below.
Location: UCSD Altman Clinical and Translational Research Institute Building — La Jolla, California
Age range: 2 Years to 17 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 (19 Sites)
- UCSD Altman Clinical and Translational Research Institute Building — La Jolla, California
- Loma Linda University Children's Hospital - PIN — Loma Linda, California
- Massachusetts General Hospital — Boston, Massachusetts
- University of Texas Southwestern Medical Center — Dallas, Texas
- Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan — Parque Patricios, Ciudad Autónoma de BuenosAires
- Hospital Santa Izabel-Rua Floriano Peixoto 300 — Salvador, Estado de Bahia
- Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS) — Porto Alegre/RS,
- CPQuali Pesquisa Clínica Sao Paulo — São Paulo,
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo — São Paulo,
- Hospital For Sick Children — Toronto, Ontario
- Centre Hospitalier Universitaire de Bicêtre — Le Kremlin-Bicêtre, Val-de-Marne
- Erasmus MC Sophia Children's Hospital-Wytemaweg 80 — Rotterdam, South Holland
- Uniwersyteckie Centrum Kliniczne w Gdansku - Smoluchowskiego 17 — Gdansk,
- Clinic for Neurology and Psychiatry for Children and Youth — Belgrade, Belgrade
- Hospital Sant Joan de Deu - PIN — Espluges de Llobregat, Barcelona
- Karolinska Universitetssjukhuset Solna — Stockholm, Stockholm County
- Evelina London Children's Hospital — London, London, City of
- Great Ormond Street Hospital - PPDS — London, London, City of
- Birmingham Women's and Children's NHS Foundation Trust — Birmingham, West Midlands
📞 Contact the Study Coordinator
Phone: (866) 572-6436
Email: medinfo@amgen.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
- 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) — Denver, Colorado
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.