2022-502481-24-00招募中2 期
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Participants with Chronic Rhinosinusitis Without Nasal Polyps – The BiRCh Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Insmed Inc.
- 入组人数
- 203
- 试验地点
- 51
- 主要终点
- Change from Baseline to the 28-day average of daily Sinus Total Symptom Score (sTSS)a at Week 24
研究概览
简要总结
-To evaluate the efficacy of brensocatib at 10 and 40 mg QD compared with placebo in improving nasal symptoms
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •"Key Inclusion Criteria: • Male or female ≥18 years old and ≤75 years old • At least a 12-week history of CRSsNP • Ongoing symptoms of nasal congestion • Blood eosinophil count of ≤750 cells/μL at Screening • Previous sinonasal surgery for CRS and/or treatment with SCS or antibiotics for CRS within a year of Screening Visit • Received a stable daily dose regimen of MFNS for at least 4 weeks before randomization"
排除标准
- •"Key Exclusion Criteria: • Diagnosis of unilateral or bilateral chronic rhinosinusitis with nasal polyps • Participants who have certain conditions or are receiving certain treatments that could adversely affect the participant’s participation in the study, put the participant at unreasonable risk by participating in the study, or interfere with assessment of the effect of treatment "
结局指标
主要结局
Change from Baseline to the 28-day average of daily Sinus Total Symptom Score (sTSS)a at Week 24
Change from Baseline to the 28-day average of daily Sinus Total Symptom Score (sTSS)a at Week 24
次要结局
- Change from Baseline in percentage of sinus (maxillary and ethmoid) opacification as measured by volumetry at Week 24
- Change from Baseline in modified Lund-MacKay (LMK) CT score at Week 24
- Participant status indicator for requiring rescue (antibiotics, SCS, and/or nasal surgery) due to worsening of any CRS symptom
- Change from Baseline to the 28-day average of daily Nasal Congestion Scores (NCS) at Weeks 24
- Change from Baseline to the 28-day average of daily Peak Nasal Inspiratory Flow (PNIF) at Week 24
- Change from Baseline in Sino-Nasal Outcome Test (SNOT-22) at Week 24
- Brensocatib plasma concentration
- Adverse events (AEs) over 24 weeks of treatment
- Clinical laboratory test results, vital signs, and electrocardiograms (ECGs) over 24 weeks of treatment
研究者
Yun Irene Gregan
Scientific
Insmed Inc.
研究点 (51)
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