A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Effect of GB001 in Patients With Chronic Rhinosinusitis With or Without Nasal Polyps
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 36
- 主要终点
- Change From Baseline to Week 16 in Sino-Nasal Outcome Test (SNOT) 22 Total Score
研究概览
简要总结
A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of GB001 compared with placebo over 16 weeks of treatment in patients with chronic rhinosinusitis with or without nasal polyposis (NP).
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
- Double (Participant, Investigator)
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
- •A diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) or chronic rhinosinusitis without nasal polyps (CRSsNP) by a physician at least 12 weeks before Screening Visit
- •Treated with stable intranasal corticosteroid (INCS) for at least 2 months prior to Screening Visit
- •Presence of at least 2 nasal symptoms: nasal blockage/ obstruction/congestion or nasal discharge or facial pain/pressure or reduction/loss of smell
- •Women of childbearing potential must use an acceptable method of contraception
排除标准
- •Sino-Nasal Outcome Test-22 (SNOT-22) score < 20 at screening
- •Asthma or chronic obstructive pulmonary disease (COPD) patients that are current smokers
- •Use of other investigational drugs within 30 days, or within 5 half-lives, whichever is longer, prior to Screening Visit
- •Pregnant or breastfeeding
- •Pre-existing clinically important co-morbidities
- •Regular use of systemic corticosteroids or immunosuppressive treatments
- •Other protocol-defined inclusion/exclusion criteria will apply.
研究组 & 干预措施
GB001
GB001 40 mg once per day (QD) for 16 weeks
干预措施: GB001 (Drug)
Placebo
Placebo QD for 16 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 16 in Sino-Nasal Outcome Test (SNOT) 22 Total Score
时间窗: Baseline, Week 16
The SNOT-22 is a validated questionnaire to assess the impact of chronic rhinosinusitis (CRS) on quality of life and utilizes a 2-week recall period. It is a 22-item outcome measure on a 5-point category scale applicable to sinonasal conditions and surgical treatments. The total scores range from 0 to 110 with higher total scores implying greater impact of CRS on quality of life.
次要结局
- Change From Baseline to Week 16 in Lund-Mackay Score(Baseline, Week 16)
- Time to First Response in NPS(up to Week 16)
- Time to First Chronic Rhinosinusitis (CRS) Exacerbation(up to Week 16)
- Change From Baseline to Week 16 in AM Total Symptom Score (TSS)(Baseline, Week 16)
- Change From Baseline to Week 16 in University of Pennsylvania Smell Identification Test (UPSIT) Score(Baseline, Week 16)
- Percentage of Participants With a Treatment-Emergent Adverse Event (AE)(From first dose of study drug through Week 20)
- Change From Baseline to Week 16 in Morning (AM) Nasal Congestion (NC) Score(Baseline, Week 16)
- Change From Baseline to Week 16 in Nasal Polyp Score (NPS)(Baseline, Week 16)