EUCTR2017-002134-23-DE进行中（未招募）1 期
Open-label, Interventional, Cohort Study to Evaluate Long-term Safety of Dupilumab 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）
- 入组人数
- 750
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
相似试验
进行中（未招募）
1 期
Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety inPatients with Asthma (Long-Term Follow-Up)MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersAsthmaEUCTR2017-002134-23-Outside-EU/EEASanofi-aventis groupe
进行中（未招募）
1 期
Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients with Asthma (Long-Term Follow-Up)AsthmaEUCTR2017-002134-23-BEsanofi-aventis groupe750
进行中（未招募）
1 期
Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients with Asthma (Long-Term Follow-Up)MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersAsthmaEUCTR2017-002134-23-FRsanofi-aventis groupe750
进行中（未招募）
1 期
Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients with Asthma (TRAVERSE CONTINUATION)MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersAsthmaEUCTR2017-002134-23-NLsanofi-aventis groupe750
已完成
3 期
Open-label, Interventional, Cohort Study to Evaluate Long-term Safety of Dupilumab in Patients with Moderate to Severe Asthma who Completed the TRAVERSE-LTS12551Clinical Trialchronic inflammatory disease of the airways10006436AsthmaNL-OMON45884Sanofi-aventis5