[Translation] A randomized, double-blind, parallel-group phase III study evaluating the efficacy and safety of 100 mg SC depemokimab in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) – ANCHOR-1 (depemokimab for chronic rhinosinusitis)
主要目的:
1、在诊断为CRSwNP的受试者中评价第52周时depemokimab组与安慰剂组相比的疗效
次要目的:
1、根据鼻溢(流鼻涕)和嗅觉丧失的症状评分,评价第52周时depemokimab组与安慰剂组相比的疗效
2、根据Lund Mackay CT评分,评价第52周时depemokimab组与安慰剂组相比的疗效
3、在诊断为CRSwNP的受试者中评价第52周时depemokimab组与安慰剂组相比对生活质量的影响
4、在诊断为CRSwNP的哮喘受试者亚组中,评价第52周时depemokimab组与安慰剂组相比对哮喘控制的影响
5、在诊断为CRSwNP的受试者中评价在第26周之前,depemokimab组与安慰剂组相比的疗效
6、在诊断为CRSwNP的患者中评价第52周时depemokimab组与安慰剂组相比对鼻部手术的影响
7、在诊断为CRSwNP的患者中评价直至第52周时depemokimab组与安慰剂组相比对全身性糖皮质激素使用的影响
[Translation] Primary objectives:
1. To evaluate the efficacy of depemokimab compared with placebo at week 52 in subjects diagnosed with CRSwNP
Secondary objectives:
1. To evaluate the efficacy of depemokimab compared with placebo at week 52 based on symptom scores of rhinorrhoea (runny nose) and anosmia
2. Based on Lund Mackay CT score, to evaluate the efficacy of the depemokimab group compared with the placebo group at week 52
3. To evaluate the effect of the depemokimab group on quality of life compared with the placebo group at week 52 in subjects diagnosed with CRSwNP
4. To evaluate the effect of the depemokimab group on asthma control compared with the placebo group at week 52 in the subgroup of asthma subjects diagnosed with CRSwNP
5. To evaluate the efficacy of the depemokimab group compared with the placebo group before week 26 in subjects diagnosed with CRSwNP
6. To evaluate the effect of the depemokimab group compared with the placebo group on nasal surgery at week 52 in patients diagnosed with CRSwNP
7. To evaluate the effect of the depemokimab group compared with the placebo group on the use of systemic glucocorticoids until week 52 in patients diagnosed with CRSwNP