NCT05891483已完成2 期
A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Phase 2 Efficacy and Safety Study of SHR-1905 in Patiens With Chronic Rhinosinusitis With Nasal Polyps
Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2023年9月4日最近更新:
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
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Nasal polyp scores (NPS)
研究概览
简要总结
The study is being conducted to evaluate the efficacy, and safety of SHR-1905 injection in subjects with chronic rhinosinusitis with nasal polyps (CRSwNP), as well as to explore the reasonable dosage of SHR-1905 injection for CRSwNP.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight ≥40kg
- •Diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP).
- •Bilateral nasal polyps at screening and baseline, total NPS ≥5, ≥2 points for each nostril.
- •NCS ≥2 at screening and baseline.
- •SNOT-22≥20 at screening period and baseline.
- •Recorded persistent NP symptoms for over 4 weeks prior to screening.
- •Subjects received standard therapy with intranasal corticosteroids (INCS) and remained stable during the 4 weeks prior to randomization.
- •NP surgery in the past and/or ACERS treated with SCS occurred within 2 years before randomization (or with contraindications/ intolerances).
排除标准
- •Any comorbidities that may affect the efficacy evaluation of nasal polyps.
- •Any comorbidities except for asthma that may affect blood EOS levels.
- •Concomitant with immunodeficiency.
- •Concomitant with contraindications or not suitable for nasal endoscopy.
- •Uncontrolled hypertension.
- •Uncontrolled diabetes.
- •Infection within 2 weeks prior to screening to randomization that is clinically significant and/or should be treated with systemic antibiotics.
- •Uncontrolled epistaxis within 4 weeks prior to randomization.
- •Major surgery performed within 3 months prior to randomization, or surgery planned during the study, or treatments that may affect evaluations according to investigators.
- •Parasitic infection within 6 months before randomization.
- •Sinus or intranasal surgery (except for diagnostic biopsy) within 6 months prior to randomization, or changes in the nasal walls caused by sinus or intranasal surgery that made NPS evaluation impossible.
- •Malignancies diagnosed within 5 years before randomization (except those with a low risk of metastasis or death).
- •Abnormalities of laboratory tests at screening or baseline.
- •Concomitant with active hepatitis B, positive hepatitis C virus antibodies, positive human immunodeficiency virus antibodies, or positive treponema pallidum antibodies.
- •Prolonged QTc interval (>450ms for male and >470ms for female) or other clinically significant abnormal results of ECG at screening or baseline that may cause significant safety risks to subjects.
- •FEV1 before the use of bronchodilator (pre-BD) was less than 50% at screening.
- •Transfusion of blood products or immunoglobulin within 4 weeks prior to randomization.
- •SCS or additional INCS use within 4 weeks before randomization, or planned use during treatment period.
- •Regular use of decongestants (local or systemic) within 4 weeks before randomization, except for during the endoscopic procedure.
- •Adnimistration of live vaccine or viral vector vaccine within 4 weeks before randomization.
- •Allergen immunotherapy within 8 weeks before randomization.
- •Smoking history ≥10 pack-years, smoking at screening, or smoking cessation less than 6 months at screening.
- •Substance abuse, drug abuse, and/or excessive alcohol consumption within 1 year prior to randomization.
- •Pregnancy (including positive pregnancy test at screening or baseline), lactation, or pregnancy plan during study period.
研究组 & 干预措施
Placebo Group
Placebo Comparator
干预措施: SHR-1905 Placebo Injection (Drug)
Treatment group A: SHR-1905 Injection（dose 1）
Experimental
干预措施: SHR-1905 Injection (Drug)
Treatment group B: SHR-1905 Injection（dose 2）
Experimental
干预措施: SHR-1905 Injection (Drug)
Treatment group C: SHR-1905 Injection（dose 3）
Experimental
干预措施: SHR-1905 Injection (Drug)
结局指标
主要结局
Nasal polyp scores (NPS)
时间窗: Baseline to Week 24
Change from baseline in NPS at Week 24.
次要结局
- Loss of smell(Baseline to Week 48)
- Nasal Congestion Scores (NCS)(Baseline to Week 48)
- NPS(Baseline to Week 48)
- Runny nose/postnasal drip(Baseline to Week 48)
- Facial pain and/or pressure(Baseline to Week 48)
- Total symptoms score (TSS)(Baseline to Week 48)
- Sino-nasal outcome test-22 (SNOT-22) scores(Baseline to Week 48)
- Proportion of subjects exposed to SCS for acute exacerbation of chronic rhinosinusitis (AECRS) over 24 weeks.(Baseline to Week 24)
- Dose of SCS used for AECRS over 24 weeks (converted to equivalent dose of prednisone).(Baseline to Week 24)
研究者
研究点 (1)
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