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
This study aims to enroll 30 participants who either participated in the open-label period (OLP) of the N-MOmentum study (CD-IA-MEDI-551-1155; NCT02200770), a global registrational study that determined the safety and efficacy of inebilizumab for treatment of NMOSD, or who are newly initiating inebilizumab treatment at the discretion of their physician at participating sites. Acquired from Horizon in 2024.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Participants will have blood tests done at each scheduled visit (approximately every 6 months).
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.
Wayne State University School of Medicine
Detroit, Michigan, United States
Baylor College of Medicine
Houston, Texas, United States
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, Hungary
Uniwersyteckie Centrum Kliniczne WUM - Oddzial Kliniczny Neurologii
Warsaw, Masovian Voivodeship, Poland
M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM
Katowice, Silesian Voivodeship, Poland
National Cancer Center - Neurology Clinic
Goyang-si, Gyeonggido [Kyonggi-do], South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea
Samsung Medical Center - Pediatric Neurology
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea
...and 1 more locations
Change from baseline in serum Ig levels (total Ig, IgG, IgM, IgA, IgE) over time
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
Time frame: Up to 42 months
Change from baseline in peripheral CD20+ B-cell counts over time
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
Time frame: Up to 42 months
Change from baseline in hematology over time
The lab parameters being assessed as part of the hematology analyses include the following: platelet count, red blood cell count, other indices of red blood cells, including MCV (mean corpuscle volume), MCH (mean corpuscle hemoglobin), % reticulocyte count, and morphology (shape); white blood count with differential, including neutrophil count, Lymphocyte count, monocyte count, eosinophils, and basophils; hemoglobin and hematocrit.
Time frame: Up to 42 months
Change from baseline in clinical chemistry over time
The lab parameters being assessed as part of clinical chemistry include blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase.
Time frame: Up to 42 months
Incidence of serious infections
Time frame: Up to 42 months
Incidence of viral reactivation
Time frame: Up to 42 months
Incidence of progressive multifocal leukoencephalopathy (PML)
Time frame: Up to 42 months
Incidence of other opportunistic infections
Time frame: Up to 42 months
Incidence of malignancies
Time frame: Up to 42 months
Incidence of infusion reactions
Time frame: Up to 42 months
Number of protocol-defined NMOSD attacks
Time frame: Up to 42 months
Percentage of protocol-defined NMOSD attacks
Time frame: Up to 42 months
Incidence of Anti-drug antibody (ADA) directed against Inebilizumab status and titers
Time frame: Up to 42 months
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