NCT05448391撤回2 期
An Open-label, Single-arm, Phase 2 Study to Evaluate the Safety and Efficacy of RIST4721 in Subjects With Familial Mediterranean Fever
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs
研究概览
简要总结
A 12-week Open-label, Single-arm, Phase 2 Study to Evaluate the Safety and Efficacy of RIST4721 in Subjects with Familial Mediterranean Fever followed by an additional Open-label Extension Phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 1 FMF disease but no active flare at the time of screening according to Tel Hashomer criteria or EUROFEVER/Paediatric Rheumatology International Trials Organization (PRINTO) criteria for FMF
- •Documented to be heterozygous or homozygous for at least one of the known clearly pathogenic MEFV gene exon 10 mutations
- •Males and females must be willing to use birth control as indicated
排除标准
- •Breastfeeding or pregnant
- •Known immunodeficiency or subject is immunocompromised
- •Active/latent infection with HBV, HCV, HIV, SARS-CoV-2 or TB
研究组 & 干预措施
RIST4721 400 mg
Experimental
RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks
干预措施: RIST4721 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs
时间窗: Baseline to Week 12
次要结局
- Proportion of responders who achieve resolution of their index flare after initiating study treatment and do not experience a new flare from the time of resolution of the index flare until Week 12(Baseline to Week 12)
研究者
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