Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)
- Conditions
- Neuromyelitis Optica Spectrum Disorder
- Interventions
- Other: Blood tests
- Registration Number
- NCT06180278
- Lead Sponsor
- Amgen
- Brief 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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Age 18 years or above, and able to provide written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America (USA), European Union [EU] Data Privacy Directive in the EU) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- 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.
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception as outlined in the protocol (subjects in the Czech Republic only must use 1 additional method of contraception) from screening, and must agree to continue using such precautions for 6 months after treatment with inebilizumab; cessation of contraception after this point should be discussed with a responsible physician.
- Nonsterilized males who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide (subjects in the Czech Republic only must use 1 additional method of contraception) from Day 1 for 3 months after receipt of last treatment with inebilizumab.
- Sterilized males, without the appropriate post-vasectomy documentation on the absence of sperm in the ejaculate, who are sexually active with a female partner of childbearing potential must use a condom and spermicide from Day 1 for 3 months after receipt of the last treatment with inebilizumab.
- 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.
- Known history of allergy or reaction to any component of inebilizumab formulation or history of anaphylaxis following any biologic therapy
- Have a severe clinically significant infection, including active chronic infection such as hepatitis B
- Have active or untreated latent tuberculosis
- Have a history of progressive multifocal leukoencephalopathy (PML)
- Is severely immunocompromised state
- Have active malignancies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Participants with NMOSD exposed to inebilizumab Blood tests 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. Participants with NMOSD exposed to inebilizumab 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 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Incidence of viral reactivation Up to 42 months Incidence of progressive multifocal leukoencephalopathy (PML) Up to 42 months Change from baseline in hematology over time Up to 42 months 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.
Incidence of serious infections Up to 42 months Incidence of malignancies 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 Incidence of infusion reactions Up to 42 months Change from baseline in clinical chemistry over time Up to 42 months 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.
Incidence of other opportunistic infections Up to 42 months
Trial Locations
- Locations (20)
Uniwersyteckie Centrum Kliniczne WUM
🇵🇱Warszawa, Mazowieckie, Poland
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ
🇭🇺Szeged, Csongrád, Hungary
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czechia
National Cancer Center
🇰🇷Goyang-si, Gyeonggido [Kyonggi-do], Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of
M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM
🇵🇱Katowice, Slaskie, Poland
Khon Kaen University, Srinagarind Hospital
🇹🇭Khon Kaen, Thailand
Khon Kaen University, Srinagarind Hospital - Division of Neurology, Depart
🇹🇭Khon Kaen, Thailand
Wayne State University School of Medicine
🇺🇸Detroit, Michigan, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Vseobecna fakultni nemocnice v Praze - Neurologicka klinika
🇨🇿Praha 2, Czechia
Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK) - Ophtalmology
🇭🇰Hong Kong, Hong Kong
Szegedi Tudományegyetem, à OK, Szent-Györgyi Albert Klinikai Központ - Neurológiai Osztály
🇭🇺Szeged, Csongrád, Hungary
National Cancer Center - Neurology Clinic
🇰🇷Goyang-si, Gyeonggido [Kyonggi-do], Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of
Samsung Medical Center - Pediatric Neurology
🇰🇷Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of
Uniwersyteckie Centrum Kliniczne WUM - Oddzial Kliniczny Neurologii
🇵🇱Warszawa, Mazowieckie, Poland
M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM
🇵🇱Katowice, Slaskie, Poland