Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder
NCT05549258 · View on ClinicalTrials.gov ↗
Study Summary
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).
Conditions Studied
Interventions
- DRUG Inebilizumab
Study Locations (19)
Other
- 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
- Uniwersyteckie Centrum Kliniczne w Gdansku - Smoluchowskiego 17 — Gdansk
California
- UCSD Altman Clinical and Translational Research Institute Building — La Jolla
- Loma Linda University Children's Hospital - PIN — Loma Linda
London, City of
- Evelina London Children's Hospital — London
- Great Ormond Street Hospital - PPDS — London
Massachusetts
- Massachusetts General Hospital — Boston
Texas
- University of Texas Southwestern Medical Center — Dallas
Ciudad Autónoma de BuenosAires
- Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan — Parque Patricios
Estado de Bahia
- Hospital Santa Izabel-Rua Floriano Peixoto 300 — Salvador
Ontario
- Hospital For Sick Children — Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-07-03 |
| Est. Completion | 2027-04-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05549258
The ClinicalTrials.gov registry entry for NCT05549258 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Neuromyelitis Optica Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention — of which Inebilizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05549258 reports 19 study locations spanning 14 distinct geographic areas — top geographies include Other, California, London, City of. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05549258 about?
NCT05549258 is a clinical study titled "Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder". 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 aga...
What is the current status of trial NCT05549258?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2023-07-03. Estimated completion is 2027-04-13.
What conditions does trial NCT05549258 study?
This clinical trial studies the following conditions: Neuromyelitis Optica Spectrum Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05549258?
The interventions under investigation include: Inebilizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05549258?
This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05549258 being conducted?
This trial has 19 study locations across California, Massachusetts, Texas, Ciudad Autónoma de BuenosAires, Estado de Bahia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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