Phase 2a Open-Label Basket Study to Evaluate Safety and Pharmacokinetics of INF904, an Oral C5aR1 Inhibitor, in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- InflaRx GmbH
- 入组人数
- 73
- 试验地点
- 47
- 主要终点
- Frequency, severity, and relatedness of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
研究概览
简要总结
The study duration for an individual subject includes screening (14 days), the treatment period (28 days) and the observational follow-up period of 28 days, in total 70 days ± 6 days. All subjects will receive IMP for 28 days followed by one End of Study (EOS) visit, 4 weeks after EOT visit.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Subjects must be 18 years or older at the time of signing the informed consent.
排除标准
- •Subjects with known severe or life-threatening hypersensitivity reaction to any other CSU/HS treatment according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE).
- •Subjects who have any other skin disease that may interfere with assessment of CSU or HS.
- •Subjects who have an active infection or history of infection(s) as follows:
- •Any infection requiring systemic treatment within 14 days prior to baseline.
- •A history of opportunistic, recurrent, or chronic infections that, in the opinion of the Investigator, might cause this study to be detrimental to the subject.
- •Subjects with known progressed liver disease (Child-Pugh B or C)
研究组 & 干预措施
Arm 6 HD
High dose of IFN904 BID
干预措施: HS high dose treatment (Drug)
Arm 1 CSU
Lower dose of IFN904 BID
干预措施: CSU lower dose treatment (Drug)
Arm 2 CSU
Higher dose of IFN904 BID
干预措施: CSU high dose treatment (Drug)
Arm 3 CSU
Non responders IgE, higher dose of IFN904 BID
干预措施: CSU non responders IgE - high dose treatment (Drug)
Arm 4 HS
Lower dose of IFN904 BID
干预措施: HS low dose treatment (Drug)
Arm 5 HD
Medium dose of IFN904 BID
干预措施: HS medium dose treatment (Drug)
结局指标
主要结局
Frequency, severity, and relatedness of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
时间窗: Through study completion, an average of 10 weeks
Frequency, severity, and relatedness of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) using MedDRA classification.
次要结局
- Systemic exposure, defined as the Area Under the Curve [AUC0-24](Through study completion, an average of 10 weeks)
- Time of occurrence of maximum plasma concentration [tmax](Through study completion, an average of 10 weeks)
- Maximum Plasma Concentration [Cmax](Through study completion, an average of 10 weeks)
- Minimum Plasma Concentration [Cmin](Through study completion, an average of 10 weeks)
- Systemic exposure, defined as the Area Under the Curve [AUClast](Through study completion, an average of 10 weeks)