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NCT06180278 · ClinicalTrials.gov registry record · Phase 4
Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)
A Phase 4 study of Neuromyelitis Optica Spectrum Disorder, sponsored by Amgen.
- Active
- Registry status
- Phase 4
- Development phase
- 32
- Enrollment target
- 11
- Study locations
NCT06180278 is a Phase 4 study of Neuromyelitis Optica Spectrum Disorder that is active but no longer recruiting, run by Amgen. The registered enrollment target is 32 participants, below the 61-participant average among 6 other Neuromyelitis Optica Spectrum Disorder trials with a reported enrollment target (48% lower). The trial reports 11 study locations across 8 states.
The verdict
NCT06180278, a Phase 4 study of Neuromyelitis Optica Spectrum Disorder, is active but no longer recruiting, sponsored by Amgen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 32 participants
- Enrollment target
- 11
- Study locations
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?
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, categorized as Phase 4. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 61-participant average among 6 other Neuromyelitis Optica Spectrum Disorder trials with a reported enrollment target (48% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
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.
NCT06180278 reports 11 study locations spanning 8 distinct geographic areas - top geographies include Other, Seoul Teugbyeolsi [Seoul-T'ukp, Michigan.
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.
What interventions are being tested in trial NCT06180278?
The interventions under investigation include: Inebilizumab (DRUG), Blood tests (OTHER).
Who is sponsoring clinical trial NCT06180278?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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