EUCTR2019-001565-33-PL进行中（未招募）1 期
A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE-XT
Ra Pharmaceuticals, Inc. (now part of UCB)0 个研究点目标入组 200 人开始时间: 2021年4月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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
- •To be eligible for this study, subjects must meet ALL of the following inclusion criteria:
- •1. Completion of a qualifying Ra Pharmaceuticals sponsored zilucoplan study
- •2. Able to provide informed consent, including signing and dating the informed consent form (ICF)
- •3. Vaccination with a quadrivalent meningococcal vaccine and, where available, meningococcal serotype B vaccine. A booster vaccination should also be administered as clinically indicated, according to the local SOC, for subjects who have been previously vaccinated against Neisseria meningitidis
- •4. Female subjects of childbearing potential must have a negative urine pregnancy test within 24 hours prior to the first dose of study drug
- •5. Sexually active female subjects of childbearing potential (i.e., women who are not postmenopausal or who have not had a hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) and all male subjects (who have not been surgically sterilized by vasectomy) must agree to use effective contraception during the study and during the safety follow-up period of 40 days after the last dose of study drug. Postmenopausal women are, for the purposes of this protocol, defined as women who have not had menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Subjects who meet ANY of the following exclusion criteria must be excluded from the study:
- •1. Pregnant, planning to become pregnant, or nursing female subjects
- •2. With the exception of a prior zilucoplan trial, participation in another concurrent clinical trial involving an experimental therapeutic intervention (participation in observational studies and/or registry studies is permitted)
- •3. Unable or unwilling to comply with the requirements of the study
- •4. Commenced any disallowed medication per the exclusion criteria from the qualifying zilucoplan study or alter the dose of any other concomitant medication, unless medically indicated
- •5. Any new or worsening medical condition (since entry into the qualifying zilucoplan study) including active malignancy (except curatively resected squamous or basal cell carcinoma of the skin); significant medical disorder; psychiatric disorder; laboratory abnormality or any other reason that, in the opinion of the investigator or Sponsor, would disqualify the subject from participation in this study
- •6. Hypersensitivity to zilucoplan, placebo or any of its excipients
研究者
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