NCT06280391已完成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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 312
- 试验地点
- 260
- 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
ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with NCFB aged 18 years of age up to 85 years of age (inclusive).
Study details include:
- The study duration (screening, 24-52-week treatment, 20-week safety follow-up) will be up to 47-77 weeks.
- The treatment duration will be up to 24-52 weeks.
- The follow-up duration will be 20 weeks.
- Site/phone visits are at a monthly interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •Participants are excluded from the study if any of the following criteria apply:
- •Have bronchiectasis due to CF, hypogammaglobulinemia, common variable immunodeficiency, known active nontuberculous mycobacteria (NTM) lung infection, or pulmonary fibrosis.
- •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).
- •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.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Itepekimab Q2W
Experimental
Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks
干预措施: Itepekimab (SAR440340) (Drug)
Itepekimab Q4W
Experimental
SC administration of Itepekimab every 4 weeks (Q4W) with alternating placebo administration at the 2week interval between active IMP as SC injection for up to 52 weeks
干预措施: Itepekimab (SAR440340) (Drug)
Itepekimab Q4W
Experimental
SC administration of Itepekimab every 4 weeks (Q4W) with alternating placebo administration at the 2week interval between active IMP as SC injection for up to 52 weeks
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
SC administration of matching placebo Q2W for up to 52 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period
时间窗: Baseline up to End of Treatment (EOT) (24-52 weeks)
Annualized rate of moderate or severe PEs over the placebo-controlled treatment period
次要结局
- Time to first severe PE over the treatment period(Baseline up to End of Treatment (EOT) (24-52 weeks))
- Change from Baseline in QOL-B Respiratory Symptoms Domain Score in Adult Participants at Week 24(Week 24)
- Percentage of participants with a decrease from baseline of at least 4 points in SGRQ total score at Week 24(Week 24)
- Percentage of participants who are severe PE free over the treatment period(Baseline up to End of Treatment (EOT) (24-52 weeks))
- Change from baseline in SGRQ total score at Week 24(Week 24)
- Serum concentrations of itepekimab from baseline to end of study(Baseline up to End of Study (EOS) (44 to 72 weeks))
- Annualized rate of severe PEs over the treatment period(Baseline up to End of Treatment (EOT) (24-52 weeks))
- Incidence of treatment-emergent anti-itepekimab antibodies (ADA) responses throughout the study(Baseline up to End of Study (EOS) (44 to 72 weeks))
- Time to first moderate or severe PE over the treatment period(Baseline up to End of Treatment (EOT) (24-52 weeks))
- Number of days of new and/or added (in participants with maintenance antibiotic use) antibiotic use(Baseline up to End of Treatment (EOT) (24-52 weeks))
- Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent study treatment discontinuation in the treatment-emergent period(Baseline up to End of Study (EOS) (44 to 72 weeks))
- Percentage of participants who are PE free over the treatment period(Baseline up to End of Treatment (EOT) (24-52 weeks))
- Change From Baseline in FEV1 at Week 8 and Week 24(Week 8 and Week 24)
研究者
研究点 (260)
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