NL-OMON53456尚未招募2 期
Imlifidase treatment for acute inflammation in AQP4-IgG associated neuromyelitis optica spectrum disorder - DEFEAT NMOSD
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- neurologie
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signed Informed Consent obtained before any study-related procedures.
- •2. Willingness and ability to comply with the protocol.
- •3. Male or female aged >=18 years at the time of screening.
- •4. NMOSD diagnosed according to the Wingerchuck criteria[6] with a positive
- •anti-AQP4 IgG serum test using a cell-based assay at presentation or in medical
- •5. Onset of weakness or loss of visual acuity due to the exacerbation of NMOSD
- •is not more than 14 days prior to administration of imlifidase.
- •6. Exacerbation of myelitis is associated with an increase in functional system
- •motor score of at least 1 point, and requires at least bilateral assistance to
- •walk; exacerbation of uni- or bilateral optic neuritis is associated with an
- •increase in functional system visual score of at least 1 point, and results in
- •a visual acuity of 20/60 to 20/99 (0.33-0.21) or worse.
- •7. Acute steroid treatment is indicated.
- •8. Incident cases or prevalent cases treated with maintenance/ prophylactic
- •therapies including azathioprine, mycophenolate mofetil/mycophenol acid, and
- •rituximab, or no maintenance treatment.
- •9. Negative serological screening test for hepatitis B surface antigen,
- •hepatitis C antibody, or human immunodeficiency virus.
- •10. Women of child-bearing potential willing or able to use at least one highly
- •effective contraceptive method from the day of treatment until at least 6
- •months after the dose of imlifidase if not abstinent. In the context of this
- •study, an effective method is defined as those which result in low failure rate
- •(i.e. less than 1% per year) when used consistently and correctly.
- •11. Men willing to use double-barrier contraception from the day of treatment
- •until at least 2 months after the dose of imlifidase if not abstinent.
排除标准
- •1. Previous treatment with imlifidase
- •2. Subjects who are already on plasma exchange.
- •3. Intravenous immunoglobulin (IVIg) treatment 28 days prior to administration
- •of imlifidase
- •4. Women of child-bearing potential unwilling or unable to use at least one
- •highly effective contraceptive method from the screening visit until at least
- •180 days following imlifidase dosing.
- •5. Hypersensitivity to IVIg or to any of the excipients.
- •6. Signs or symptoms suggestive of Thrombotic Thrombocytopenic Purpura
- •7. Subject known to have a severe concurrent disease, e.g. malignancy, severe
- •cardiovascular disease and severe chronic obstructive pulmonary disease.
- •8. Any condition that in the opinion of the investigator could increase the
- •subject's risk by participating in the study or confound the outcome of the
- •9. Known mental incapacity or language barriers precluding adequate
- •understanding of the Informed Consent information and the study activities.
- •10 Subjects with clinical signs of ongoing infectious diseases that requires
- •11. Subjects with active SARS-CoV-2 (COVID-19) infection as shown by PCR
- •12. Subjects should not have received other investigational drugs within 5
- •half-lives prior to imlifidase dosing.
研究者
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