2023-508663-70-00进行中（未招募）2 期
A randomized, double-blind, placebo-controlled, parallel-group, Proof-of-Concept (PoC) study to assess the efficacy, safety and tolerability of itepekimab, in participants with non-cystic fibrosis bronchiectasis
Sanofi-Aventis Recherche & Developpement53 个研究点 分布在 9 个国家目标入组 138 人开始时间: 2024年5月29日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 138
- 试验地点
- 53
- 主要终点
- Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period
研究概览
简要总结
Evaluate the efficacy of itepekimab compared with placebo on occurrence of pulmonary exacerbations (PEs) in non-cystic fibrosis bronchiectasis (NCFB)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Participant must be 18 to 85 years of age inclusive.
- •Clinical history consistent with NCFB (cough, chronic sputum production and/or recurrent respiratory infections).
- •Participants with a FEV1 % predicted ≥30%.
- •Participants with at least 2 moderate or 1 severe Pulmonary exacerbations (PEs) in the past 12 months.
排除标准
- •Have bronchiectasis due to CF, hypogammaglobulinemia, common variable immunodeficiency, known active nontuberculous mycobacteria (NTM) lung infection, or pulmonary fibrosis.
- •Participants with active autoimmune disease or participants using immunosuppressive therapy for autoimmune disease
- •Known allergy to itepekimab or to excipients
- •Live-attenuated vaccine(s) within 4 weeks prior to Screening or plans to receive such vaccines during the study
- •Unstable ischemic heart disease
- •Cardiomyopathy or other relevant cardiovascular disorder
- •Clinically significant new abnormal electrocardiogram (ECG) within 6 months prior to, or at Screening
- •History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Screening.
- •Known or suspected immunodeficiency disorder.
- •Pulmonary exacerbation which has not resolved clinically during screening period.
- •Have significant haemoptysis.
- •Have any clinically significant abnormal laboratory values at Screening or diseases or disorders.
- •History of lung transplantation.
- •History of malignancy within 5 years before Screening, or during the screening period
- •Currently being treated with antimicrobial therapy for tuberculosis (TB).
- •Currently on active treatment for allergic bronchopulmonary aspergillosis (ABPA).
结局指标
主要结局
Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period
Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period
次要结局
- Change from baseline in SGRQ total score at Week 24
- Change from Baseline in QOL-B Respiratory Symptoms Domain Score in Adult Participants at Week 24
- Annualized rate of severe PEs over the treatment period
- Percentage of participants who are severe PE free over the treatment period
- Time to first severe PE over the treatment period
- Change From Baseline in FEV1 at Week 8 and Week 24
- Number of days of new and/or added (in participants with maintenance antibiotic use) antibiotic use
- Time to first moderate or severe PE over the treatment period
- Percentage of participants who are PE free over the treatment period
- Percentage of participants with a decrease from baseline of at least 4 points in SGRQ total score at Week 24
- Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent study treatment discontinuation in the treatment-emergent period
- Serum concentrations of itepekimab from baseline to end of study
- Incidence of treatment-emergent anti-itepekimab antibodies (ADA) responses throughout the study
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Recherche & Developpement
研究点 (53)
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