Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)
NCT06180278 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to understand the effects of long-term treatment with inebilizumab on circulating levels of immunoglobulins, B-cell counts, and other safety measures, and to further monitor repletion of immunoglobins and B-cell counts in participants with NMOSD who discontinue treatment. The objectives include: 1. To establish the nadir in circulating immunoglobulins (Ig) during chronic treatment with inebilizumab and ascertain the time needed to ensure restoration of pre-treatment baseline serum levels of IgG and IgM after discontinuation of treatment 2. To characterize B-cell counts throughout treatment with inebilizumab and after discontinuation until repletion of Immunoglobulin (Ig levels) 3. To assess long-term safety of inebilizumab 4. To assess other long-term effects of inebilizumab
Conditions Studied
Interventions
- DRUG Inebilizumab
- OTHER Blood tests
Study Locations (11)
Other
- Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK) - Ophtalmology — Hong Kong
- Vseobecna fakultni nemocnice v Praze - Neurologicka klinika — Prague
- Khon Kaen University, Srinagarind Hospital - Division of Neurology, Depart — Khon Kaen
Seoul Teugbyeolsi [Seoul-T'ukp
- Seoul National University Hospital — Seoul
- Samsung Medical Center - Pediatric Neurology — Seoul
Michigan
- Wayne State University School of Medicine — Detroit
Texas
- Baylor College of Medicine — Houston
Csongrád megye
- Szegedi Tudományegyetem, à OK, Szent-Györgyi Albert Klinikai Központ - Neurológiai Osztály — Szeged
Masovian Voivodeship
- Uniwersyteckie Centrum Kliniczne WUM - Oddzial Kliniczny Neurologii — Warsaw
Silesian Voivodeship
- M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM — Katowice
Gyeonggido [Kyonggi-do]
- National Cancer Center - Neurology Clinic — Goyang-si
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2024-04-02 |
| Est. Completion | 2028-06-26 |
| Phase | Phase 4 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06180278
The ClinicalTrials.gov registry entry for NCT06180278 describes a study currently listed as active not recruiting. It is categorized as Phase 4, 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 32 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 2 interventions — 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: NCT06180278 reports 11 study locations spanning 8 distinct geographic areas — top geographies include Other, Seoul Teugbyeolsi [Seoul-T'ukp, Michigan. 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 NCT06180278 about?
NCT06180278 is a clinical study titled "Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)". The purpose of this study is to understand the effects of long-term treatment with inebilizumab on circulating levels of immunoglobulins, B-cell counts, and other safety measures, and to further monitor repletion of immunoglobins and B-cell counts in participants with NMOSD who discontinue treatment...
What is the current status of trial NCT06180278?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 32 participants. The study started on 2024-04-02. Estimated completion is 2028-06-26.
What conditions does trial NCT06180278 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 NCT06180278?
The interventions under investigation include: Inebilizumab (DRUG), Blood tests (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06180278?
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 NCT06180278 being conducted?
This trial has 11 study locations across Michigan, Texas, Csongrád megye, Masovian Voivodeship, Silesian Voivodeship. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.