A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Change From Baseline at Week 16 in Bilateral Nasal Polyp Score (NPS)
研究概览
简要总结
This study will evaluate the effect and safety of 611 in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).
详细描述
The main purpose is to evaluate the effect of 611 on a background of mometasone furoate nasal spray (MFNS) in reducing endoscopic nasal polyp score (NPS) and nasal congestion/obstruction score (NCS) severity in eligible patients with CRSwNP whose disease remains inadequately controlled despite daily treatment with intranasal corticosteroid (INCS) therapy in comparison to placebo.
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
- •Female and male patients aged ≥18 and ≤ 75 years at the time of screening.
- •Bilateral CRSwNP.
- •Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity
- •Nasal Congestion Score of > 2 at screening and a weekly average severity of > 1 at time of randomization.
- •Patients whose bilateral sino-nasal polyposis remains inadequately controlled despite prior treatment with SCS anytime within the past 2 years; and/or had a medical contraindication/intolerance to SCS; and/or received nasal polyp surgery 6 months before signing the ICF.
排除标准
- •Patients with other nasal diseases or symptoms.
- •Patients who are taking or have taken the following prohibited therapies as specified, e.g., systemic steroids within 4 weeks prior to screening, less than 3 months or 5 half-lives for biologic therapy prior to screening.
- •Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
- •History of cancer.
- •Known or suspected history of immunosuppression.
- •Known with allergic or intolerant to mometasone furoate spray or 611/placebo.
研究组 & 干预措施
611 Dose A
611 300 mg Q2W, subcutaneous (SC) injection.
干预措施: 611 (Drug)
611 Dose B
611 450 mg Q4W, subcutaneous (SC) injection.
干预措施: 611 (Drug)
Placebo
Placebo subcutaneous (SC) injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline at Week 16 in Bilateral Nasal Polyp Score (NPS)
时间窗: Up to 16 weeks
NPS is evaluated by nasal endoscopy. For each nostril, NPS is graded based on polyp size from 0 = no polyps to 4 = large polyps causing complete obstruction of inferior nasal cavity; lower score = smaller sized polyps. Bilateral NPS is the sum of right and left nostril scores, ranges from 0 (no polyps) to 8 (large polyps), higher score = more severe disease.
Change From Baseline at Week 16 in Nasal Congestion Symptom Severity Score (NCS)
时间窗: Up to 16 weeks
NCS is assessed by the participants daily from visit 1 and throughout the study on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicates more severity.
次要结局
- Change From Baseline to the End of study in Lund Mackay Score(Up to 16 weeks)
- Change From Baseline to the End of study in Total Nasal Symptom Score (TNSS)(Up to 16 weeks)
- Change From Baseline to the End of study in the University of Pennsylvania Smell Identification Test (UPSIT) Score(Up to 16 weeks)
- Change From Baseline to the End of study in 22-item Sino-nasal Outcome Test (SNOT-22) Scores(Up to 16 weeks)
- 611 Concentration in Serum(Up to 24 weeks)