JPRN-jRCT2080223977招募中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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Diagnosis of NMO/NMOSD
- •- Confirmation of NMO/NMOSD status:
- •1. 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
- •2. 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
- •- Able and willing to give written informed consent and comply with the requirements of the study protocol
- •- EDSS <= 7.5 (8 in special circumstances)
- •- 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
- •- Lactating and pregnant females
- •- Treatment with any investigational agent within 4 weeks of screening
- •- Known history of a severe allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy.
- •- Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization.
- •- History of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to randomization
- •- Receipt of the following at any time prior to randomization:
- •1. Alemtuzumab
- •2. Total lymphoid irradiation
- •3. Bone marrow transplant
- •4. T-cell vaccination therapy
- •- Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal.
- •- Receipt of IVIG within 1 month prior to randomization.
- •- Receipt of any of the following within 3 months prior to randomization:
- •1. Natalizumab (Tysabri)b.
- •2. Cyclosporin
- •3. Methotrexate
- •4. Mitoxantrone
- •5. Cyclophosphamide
- •6. Tocilizumab
- •7. Eculizumab
- •- History of Hepatitis B and/or Hepatitis C (Hep B/C at screening)
- •- Known history of a primary immunodeficiency (congenital or acquired) or an underlying condition such as human immunodeficiency virus (HIV) infection
- •- 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
- •- 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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