[Translation] A randomized, double-blind, placebo-controlled, proof-of-concept (PoC) study to evaluate the efficacy, safety, and tolerability of itepekimab in participants with inadequately controlled chronic rhinosinusitis without nasal polyps
主要目的:评价 itepekimab 与安慰剂相比对鼻窦浑浊的疗效。
次要目的:评价 itepekimab 与安慰剂相比对鼻窦症状的疗效;评价 itepekimab 与安慰剂相比对慢性鼻窦炎不伴鼻息肉(CRSsNP)症状的疗效;评价 itepekimab 与安慰剂相比对健康相关生活质量(HRQoL)的疗效;评价 itepekimab 与安慰剂相比对其他鼻窦浑浊指标的疗效;评价 itepekimab 与安慰剂相比在 CRSsNP 参与者中的安全性和耐受性;评价 itepekimab 的 PK。Itepekimab 免疫原性评估。
[Translation] Primary objective: To evaluate the efficacy of itepekimab compared with placebo on sinus opacity.
Secondary objectives: To evaluate the efficacy of itepekimab compared with placebo on sinus symptoms; To evaluate the efficacy of itepekimab compared with placebo on symptoms of chronic rhinosinusitis without nasal polyps (CRSsNP); To evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL); To evaluate the efficacy of itepekimab compared with placebo on other sinus opacity indicators; To evaluate the safety and tolerability of itepekimab compared with placebo in CRSsNP participants; To evaluate the PK of itepekimab. Itepekimab immunogenicity assessment.