A Long-term, Open-label, Low-interventional Safety Study of Inebilizumab in the Treatment of NMOSD (N-MOmentum LT)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen
- 入组人数
- 32
- 试验地点
- 11
- 主要终点
- Change from baseline in serum Ig levels (total Ig, IgG, IgM, IgA, IgE) over time
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Participants with NMOSD exposed to 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.
干预措施: Blood tests (Other)
Participants with NMOSD exposed to 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.
干预措施: Inebilizumab (Drug)
结局指标
主要结局
Change from baseline in serum Ig levels (total Ig, IgG, IgM, IgA, IgE) over time
时间窗: 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
时间窗: 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
次要结局
- Incidence of progressive multifocal leukoencephalopathy (PML)(Up to 42 months)
- Change from baseline in hematology over time(Up to 42 months)
- Incidence of viral reactivation(Up to 42 months)
- 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 infusion reactions(Up to 42 months)
- Incidence of Anti-drug antibody (ADA) directed against Inebilizumab status and titers(Up to 42 months)
- Change from baseline in clinical chemistry over time(Up to 42 months)
- Incidence of other opportunistic infections(Up to 42 months)