NL-OMON46416
已完成
2 期
A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - N-MOmentum
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- MedImmune LLC
- 入组人数
- 3
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
Trial ended prematurely
研究者
入排标准
入选标准
- •1\) Men and women 18 years or older with diagnosis of NMO/NMOSD.
- •2\) Confirmation of NMO/NMOSD status:
- •a.) AQP4\-IgG sero\-positive NMO/NMOSD with at least one attack requiring rescue
- •therapy in the last year or two attacks requiring rescue therapy in the last 2 years.
- •b.) AQP4\-IgG sero\-negative NMO with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years.
- •3\) EDSS \<\= 7\.5 (8 in special circumstances).
- •4\) Men and women of reproductive potential must agree to use a highly effective method of birth control from screening to 6 months after final dose of the investigational product.
排除标准
- •1\) Lactating and pregnant females.
- •2\) Treatment with any investigational agent within 4 weeks of screening.
- •3\) Known history of a severe allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy.
- •4\) Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization.
- •5\) History of of alcohol, drug, or chemical abuse, or a recent history of such abuse \< 1 year prior to randomization.
- •6\) Receipt of the following at any time prior to randomization:
- •a) Alemtuzumab
- •b) Total lymphoid irradiation
- •c) Bone marrow transplant
- •d) T\-cell vaccination therapy
结局指标
主要结局
未指定
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