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: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (37 items).
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 ChecklistCheck 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).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the Investigational Product or interpretation of participant safety or study results.
- Concurrent/previous enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 published half-lives of the investigational treatment, whichever is the longer, prior to Day 1.
- Evidence of significant hepatic, renal, or metabolic dysfunction or significant hematological abnormality (one repeat test may be conducted to confirm results within the same screening period).
- B-cell counts \< one-half of the lower limit of normal (LLN) for age according to the central laboratory.
- Receipt of the following at any time prior to Day 1:
- Alemtuzumab
- Total lymphoid irradiation
- Bone marrow transplant
- T-cell vaccination therapy
- Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior to screening unless B-cell counts have returned to ≥ one-half the LLN.
- Receipt of intravenous immunoglobulin (IVIG) within one month prior to Day 1.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 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
- 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
- Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD — Washington D.C., District of Columbia
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.