Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)

Study Overview
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Brief Summary
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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: 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 To characterize B-cell counts throughout treatment with inebilizumab and after discontinuation until repletion of Immunoglobulin (Ig levels) To assess long-term safety of inebilizumab To assess other long-term effects of inebilizumab

Detailed Description
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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.

Official Title
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A Long-term, Open-label, Low-interventional Safety Study of Inebilizumab in the Treatment of NMOSD (N-MOmentum LT)

Conditions
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Neuromyelitis Optica Spectrum Disorder

Intervention / Treatment
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* Other: Blood tests
* Drug: Inebilizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide informed consent. Have completed at least 2 years in the open-label period of the N-MOmentum study or are newly initiating inebilizumab treatment at a participating site. Exclusion Criteria: Have any condition that would place the participant at unacceptable risk of complications, interfere with evaluation of inebilizumab or confound the interpretation of participant safety or study results. Received rituximab or any other B-cell depleting agent after exit from N-MOmentum study, or within the last 12 months prior to screening for non N-MOmentum participants.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Participants with NMOSD exposed to inebilizumab<br>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 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. | Other: Blood tests<br>* Participants will have blood tests done at each scheduled visit (approximately every 6 months).<br>Drug: Inebilizumab<br>* 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.<br>* Other names: UPLIZNA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Up to 42 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to 42 months | 
| Incidence of serious infections |  | Up to 42 months | 
| Incidence of viral reactivation |  | Up to 42 months | 
| Incidence of progressive multifocal leukoencephalopathy (PML) |  | Up to 42 months | 
| Incidence of other opportunistic infections |  | Up to 42 months | 
| Incidence of malignancies |  | Up to 42 months | 
| Incidence of infusion reactions |  | Up to 42 months | 
| Number of protocol-defined NMOSD attacks |  | Up to 42 months | 
| Percentage of protocol-defined NMOSD attacks |  | Up to 42 months | 
| Incidence of Anti-drug antibody (ADA) directed against Inebilizumab status and titers |  | Up to 42 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uplizna, Immunoglobulins, B-cell count, inebilizumab