Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)
Condition(s) studied
Investigational drug(s) / intervention(s)
Blood tests: Participants will have blood tests done at each scheduled visit (approximately every 6 months).
Inebilizumab: Participants with NMOSD who previously enrolled in N-MOmentum study, who participated for at least 2 years in the open label phase (OLP) of the study, and participants newly initiating inebilizumab treatment at the discretion of their treating physician will have hematology, chemistry, B-cell count, serum immunoglobulin (Ig) levels, adverse events, concomitant medications list, NMOSD attacks information, antidrug antibody (ADA) status and titers collected.
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
Eligibility
Primary outcome measure(s)
- Change from baseline in serum Ig levels (total Ig, IgG, IgM, IgA, IgE) over time — Up to 42 months
This will be assessed via serum samples, drawn at the site and processed at a central laboratory, and analyses performed to assess change from baseline over time, as measured by each parameter in mg/dL - Change from baseline in peripheral CD20+ B-cell counts over time — Up to 42 months
This will be assessed via serum samples, drawn at the site and processed at a central laboratory, and analyses performed to assess change from baseline over time, as measured by each parameter in cells/mL
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| Wayne State University School of Medicine | Detroit | Michigan | |
| Baylor College of Medicine | Houston | Texas | |
| Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK) - Ophtalmology | Hong Kong | China | |
| Vseobecna fakultni nemocnice v Praze - Neurologicka klinika | Prague | Czechia | |
| Szegedi Tudományegyetem, à OK, Szent-Györgyi Albert Klinikai Központ - Neurológiai Osztály | Szeged | Csongrád megye | |
| Uniwersyteckie Centrum Kliniczne WUM - Oddzial Kliniczny Neurologii | Warsaw | Masovian Voivodeship | |
| M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM | Katowice | Silesian Voivodeship | |
| National Cancer Center - Neurology Clinic | Goyang-si | Gyeonggido [Kyonggi-do] | |
| Seoul National University Hospital | Seoul | Seoul Teugbyeolsi [Seoul-T'ukp | |
| Samsung Medical Center - Pediatric Neurology | Seoul | Seoul Teugbyeolsi [Seoul-T'ukp | |
| Khon Kaen University, Srinagarind Hospital - Division of Neurology, Depart | Khon Kaen | Thailand |
More Amgen trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06180278 on ClinicalTrials.gov ↗ ← All trials in South Korea