NCT06414954招募中2 期
A Phase 2b, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 3 Dose Levels of NMD670 Over 21 Days in Adult Patients With AChR/MuSK-Ab+ Myasthenia Gravis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 76
- 主要终点
- Change from baseline to day 21 in QMG total score for NMD670 vs placebo
研究概览
简要总结
This Phase 2 proof-of-concept, dose range finding study aims to evaluate the safety and efficacy of 3 dose levels of NMD670 vs placebo in adult patients with MG with antibodies against AChR or MuSK, administered twice a day (BID) for 21 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be a male or female being 18 or more, at the time of signing the informed consent
- •Diagnosis of MG, MGFA class II, III or IV
- •Documented positive AChR or MuSK antibody test.
- •Participant must be able to swallow tablets
- •Body mass index between 18 and 35 kg/m2, inclusive, at screening, and with a minimum weight of 40 kg
- •Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •Participant is capable of and has given signed informed consent
排除标准
- •Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the patient's full participation in the study, pose any additional risk for the patient, or confound the assessment of the patient or outcome of the study
- •Participants with other significant clinical and/or laboratory safety findings that may interfere with the conduction or interpretation of the study
- •Participants that received treatment with an investigational medical product within 30 days or 5 half-lives of the medication, whichever is longer prior to Day 1
- •Participants with history of poor compliance with relevant MG therapy
- •Female patients who plan to become pregnant during the study or are currently pregnant or breastfeeding
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
NMD670 high dose
Experimental
干预措施: NMD670 (Drug)
NMD670 mid dose
Experimental
干预措施: NMD670 (Drug)
NMD670 low dose
Experimental
干预措施: NMD670 (Drug)
结局指标
主要结局
Change from baseline to day 21 in QMG total score for NMD670 vs placebo
时间窗: Baseline to day 21
Scale goes from 0-39 and higher score indicates worse symptomatology
次要结局
- Change from baseline to day 21 in MGC total score for NMD670 vs placebo(Baseline to day 21)
- Change from baseline to day 21 in MG-QOL15r for NMD670 vs placebo(Baseline to day 21)
- Incidence of treatment emergent adverse event(Over 21 days of dosing)
- Incidence of serious treatment emergent adverse events(Over 21 days of dosing)
- Incidence of clinically significant abnormalities on physical examinations(Over 21 days of dosing)
- Change from baseline to day 21 in MG-ADL total score for NMD670 vs placebo(Baseline to day 21)
- Change from baseline to day 21 in Neuro-QoL Fatigue Short Form(Baseline to day 21)
- Incidence of clinically significant abnormalities on safety laboratory parameters(Over 21 days of dosing)
- Incidence of clinically significant ECG abnormalities(Over 21 days of dosing)
- Incidence of Suicidal Ideation or Suicidal Behavior(Over 21 days of dosing)
- Incidence of clinically significant abnormalities on opthalmological examinations(From screening (day -28 to day -1) until follow up (day 28))
- Incidence of clinically significant vital signs abnormalities(Over 21 days of dosing)
研究者
研究点 (76)
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