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
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Sanofi
- 入组人数
- 700
- 试验地点
- 436
- 主要终点
- Incidence of treatment-emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation
研究概览
简要总结
This is a parallel, double blind, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments.
The primary purpose of this study is to evaluate safety and tolerability of both itepekimab SC Q2W or itepekimab SC Q4W in participants with COPD having completed the treatment period of the clinical studies EFC16750 or EFC16819. A secondary purpose of this study is to provide efficacy outcomes beyond the treatment period of the parent trials EFC16750 and EFC16819.
Study details include:
- The study duration will be up to 72 weeks
- The treatment duration will be up to 52 weeks
- A follow-up period of 20 weeks will be conducted
- The number of on-site visits will be 7 and the number of phone contacts will be 5
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •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 Q4W
SC administration of Itepekimab every 4 weeks (Q4W) for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP
干预措施: Placebo (Drug)
Itepekimab Q2W
Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks
干预措施: Itepekimab (SAR440340) (Drug)
Itepekimab Q4W
SC administration of Itepekimab every 4 weeks (Q4W) for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP
干预措施: Itepekimab (SAR440340) (Drug)
结局指标
主要结局
Incidence of treatment-emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation
时间窗: Baseline up to Week 72
All AEs (serious or nonserious) will be collected from the signing of the informed consent form (ICF) until the end of study visit
次要结局
- Functional itepekimab concentrations in serum(Baseline up to Week 52)
- Incidence of treatment-emergent (TE) anti-drug antibody responses(Baseline up to Week 72)
- Annualized rate of moderate-to-severe acute exacerbation of COPD (AECOPD)(Baseline up to Week 52)
- Annualized rate of severe AECOPD(Baseline up to Week 52)
- Time to first moderate-to-severe AECOPD(Baseline up to Week 52)
- Time to first severe AECOPD(Baseline up to Week 52)
- Change from baseline of the parent studies (EFC16750, EFC16819): Pre-BD and post-BD FEV1(Baseline of the parent studies (EFC16750,EFC16819) up to Week 52)
- Change from baseline of the parent studies (EFC16750, EFC16819): SGRQ total score and domain scores(Baseline of the parent studies (EFC16750,EFC16819) up to Week 52)
- Change from baseline of the parent studies (EFC16750, EFC16819): EQ-5D-5L single index score(Baseline of the parent studies (EFC16750,EFC16819) up to Week 52)
- Change from baseline of the parent studies (EFC16750, EFC16819): EQ-VAS(Baseline of the parent studies (EFC16750,EFC16819) up to Week 52)
- Change from Week 0 for CASA-Q(Baseline up to Week 52)