A Double-blinded Extension Study to Evaluate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Participated in Either EFC18418 or EFC18419 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
- 59
- 试验地点
- 23
- 主要终点
- Incidence of treatment-emergent adverse events (AEs), adverse events of special interest (AESIs), serious adverse events (SAEs), AEs leading to death, and AEs leading to permanent treatment discontinuation
研究概览
简要总结
This is a double-blind, parallel-group, 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 new or continued treatment with itepekimab 300 mg SC high dose or itepekimab 300 mg SC low dose in participants with CRSwNP having completed the intervention period of the clinical studies EFC18418 or EFC18419. A secondary purpose of this study is to provide efficacy outcomes beyond the intervention period of the parent trials EFC18418 and EFC18419.
Study details include:
- The study duration will be up to 72 weeks.
- The intervention duration will be 52 weeks.
- A follow-up period of 20 weeks will be conducted.
- The number of visits will be 8 and the number of phone contacts will be 4.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with CRSwNP who completed the 52-weeks intervention period in a previous itepekimab CRSwNP Phase 3 clinical study (ie, EFC18418 or EFC18419) and for which an EOT visit occurred no later than 5 days before the enrollment visit of this study.
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- •Is not a women of childbearing potential (WOCBP), OR
- •Is a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 20 weeks after the last dose of study intervention.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •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 other 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 participant's potential participation in a clinical trial.
研究组 & 干预措施
Itepekimab high dose
Subcutaneous (SC) administration of Itepekimab high dose for 52 weeks
干预措施: Itepekimab (SAR440340) (Drug)
Itepekimab low dose
SC administration of Itepekimab low dose for 52 weeks
干预措施: Placebo (Drug)
Itepekimab low dose
SC administration of Itepekimab low dose for 52 weeks
干预措施: Itepekimab (SAR440340) (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (AEs), adverse events of special interest (AESIs), serious adverse events (SAEs), AEs leading to death, and AEs leading to permanent treatment discontinuation
时间窗: Baseline to EOS (Week 72)
All AEs (serious or nonserious) will be collected from the signing of the ICF until end of study (EOS) visit
次要结局
- Change from baseline of the parent studies (EFC18418, EFC18419) in endoscopic NPS(Baseline to Week 52)
- Change from baseline of the parent studies (EFC18418, EFC18419) in NCS(Baseline to EOS (Week 72))
- Functional itepekimab concentration in serum(Baseline to EOS (Week 72))
- Incidence of treatment-emergent anti-drug antibody (ADA) responses(Baseline to EOS (Week 72))
- Proportion of participants with CRSwNP requiring systemic corticosteroid(s) (SCS) or surgery for chronic rhinosinusitis (CRS)(Baseline up to Week 52)
- Annualized rate of SCS course or surgery for CRS(Baseline up to Week 52)