EUCTR2020-001542-19-FR进行中（未招募）1 期
A 12-Week Multicentre, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Placebo in Patients > 6 years of age with EB simplex generalized severe - EB
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- CHU NICE
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
- •- Male or female patients 6 years or older
- •- Laboratory confirmed diagnosis of EBS-gen sev due to KRT5 or 14 mutation
- •- DLQI or cDLQI = 10
- •- Subject/caregiver agrees not to use any topical therapies other than the investigator approved
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 25
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- EBS lesions requiring oral therapy to treat an infection
- •- Use of any diacerein containing product within 6 months prior to Visit 1
- •- Use of systemic immunotherapy or cytotoxic chemotherapy within 60 days prior to Visit
- •- Use of systemic steroidal therapy within 30 days prior to Visit 1
- •- Use of any systemic product that, in the opinion of the investigator, might put the subject at undue risk by study participation or interferes with the study assessments within 30 days prior to Visit 1
研究者
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