EUCTR2014-000253-36-CZ进行中（未招募）1 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. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 231
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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) Able and willing to give written informed consent and comply with the requirements of the study protocol.
- •4) EDSS <= 7.5 (8 in special circumstances).
- •5) 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 221
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
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
- •7) Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal.
- •8) Receipt of IVIG within 1 month prior to randomization.
- •9) Receipt of any of the following within 3 months prior to randomization:
- •a) Natalizumab (Tysabri®)
- •b) Cyclosporin
- •c) Methotrexate
- •d) Mitoxantrone
- •e) Cyclophosphamide
- •f) Tocilizumab
- •g) Eculizumab
- •10) History of Hepatitis B and/or Hepatitis C (Hep B/C at screening).
- •11) Known history of a primary immunodeficiency (congenital or acquired) or an underlying condition such as human immunodeficiency virus (HIV) infection.
- •12) History of malignancies, apart from squamous cell or basal cell carcinoma of the skin treated with documented success of curative therapy > 3 months prior to randomization.
- •13) Any concomitant disease other than NMO/NMOSD that required treatment with oral or intravenous steroids at doses over 20 mg a day for over 21 days.
研究者
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