CTIS2023-508085-15-00招募中1 期
A double-blinded extension study to evaluate the long-term safety and tolerability of itepekimab in patients with chronic obstructive pulmonary disease (COPD) who participated in either EFC16750 or EFC16819 clinical studies - LTS18133
Sanofi-Aventis Recherche & Developpement0 个研究点目标入组 708 人开始时间: 2024年1月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 708
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Patients with COPD who completed the treatment period in a previous itepekimab COPD Phase 3 clinical study (ie, EFC16750 or EFC16819) and for which an end-of-treatment (EOT) visit occurred no later than 3 days before the enrolment visit of this study
排除标准
- •Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma of the skin, Any opportunistic infection during the parent study, such as tuberculosis (TB) or other infections whose nature or course may suggest an immunocompromised status, Anaphylactic reactions or systemic allergic reactions that are related to IMP and require treatment during the parent study, Any situation that led to a permanent premature IMP discontinuation in parent trials
研究者
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