EUCTR2016-002698-36-BE进行中（未招募）1 期
A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis.
CB Biopharma SPR0 个研究点目标入组 42 人开始时间: 2016年11月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
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
- •- Subject has a well-documented diagnosis of myasthenia gravis (MG) at Visit 1 (Screening), based on subject history and supported by previous evaluations
- •- Subject would currently be considered for treatment with immunological therapy (immunoglobulin/plasma exchange
- •(IVIG/PLEX)) by the investigator
- •-Subject has well-documented record of autoantibodies against antiacetylcholine receptor (Anti-AChR) or anti-muscle specific kinase (Anti- MuSK) prior to Screening
- •- Female subjects must either be: postmenopausal, permanently sterilized or if childbearing potential applicable will use a highly effective method of birth control
- •- Male subjects must be willing to use a method of contraception
- •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 37
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- Subject has previously received treatment in this study or subject has previously been exposed to UCB7665
- •- Subject has participated in another study of an investigational medicinal product (IMP;or a medical device) within the previous 30 days of Screening or is currently participating in another study of an
- •investigational medicinal product (IMP; or a medical device)
- •- Subject has a known hypersensitivity to any components of the IMP
- •- Subject has a history of hyperprolinemia, since L-proline is a constituent of the UCB7665 IMP
- •- Subjects with Myasthenia Gravis (MG) only affecting the ocular muscles
- •- Subjects with severe weakness affecting oropharyngeal or respiratory muscles, or who have myasthenic crisis at Screening or impending crisis
- •- Subject has quantitative myasthenia gravis (QMG) score of <11 at Baseline
- •- Subject has a serum total immunoglobulin G (IgG) level <= 6g/L at Screening
- •- Absolute neutrophil count <1500 cells/mm3
- •- Subject has any medical condition (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject’s ability to participate in this study
- •- Subject has any laboratory abnormality that, in the opinion of the investigator, is clinically significant, has not resolved at randomization, and could jeopardize or would compromise the subject’s ability to participate in this study
- •- Subject has received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of IMP
- •- Subject has received any experimental biological agent within or outside of a clinical study in the past 3 months or within 5 half-lives prior to Baseline (whichever is longer)
研究者
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