EUCTR2017-002134-23-Outside-EU/EEA进行中（未招募）1 期
Open-label, Interventional, Cohort Study to Evaluate Long-term Safety ofDupilumab in Patients with Moderate to Severe Asthma who Completed the TRAVERSE-LTS12551Clinical Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •-Patients with asthma who completed the treatment period in the
- •previous dupilumab asthma clinical study LTS12551.
- •-Signed written informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 560
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •- Patients who experienced any systemic hypersensitivity reactions to
- •the IMP in the previous dupilumab asthma study, which, in the opinion of
- •the Investigator, could indicate that continued treatment with dupilumab
- •may present an unreasonable risk for the patient
- •- Clinically significant comorbidity/lung disease other than asthma
- •- Patients with active autoimmune disease or patients who, as per
- •Investigator's medical judgment, are suspected of having high risk for
- •developing autoimmune disease
- •- History of malignancy within 5 years before enrollment except
- •completely treated in situ carcinoma of the cervix, completely treated
- •and resolved nonmetastatic squamous or basal cell carcinoma of the skin
研究者
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已完成
3 期
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