A Randomized, Double Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy, Safety of GR1802 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change From Baseline at Week 16 in Nasal Congestion/Obstruction Symptom(NCS) Severity Score
研究概览
简要总结
This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of GR1802 injection in comparison to placebo in addition to a background treatment of mometasone furcate nasal spray (MFNS) in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). Patients will receive GR1802 injection or Placebo every 2 Weeks.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial evaluating the preliminary efficacy and safety of GR1802 injection in patients with chronic rhinosinusitis with nasal polyps.
The study consists of a Screening/run-in Period (up to 4 weeks), a Randomized, Double Blind Treatment Period (16 weeks) and a Safety Follow-up Period (8 weeks).
70 subjects will be randomized 1:1 into the 300 mg first dose doubling Q2W group and the placebo Q2W group. Throughout the dosing period, all subjects continued treatment with standard therapy at a stable dose.
Patient-reported outcome including Nasal congestion score will be collected using patient diary. Central reading will be implemented to Nasal endoscopic nasal polyp score (NPS) and nasal polyp biopsy tissue analysis to eosinophil counts & percentage.
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)
盲法说明
Double blind
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
- •Bilateral CRSwNP with prior treatment with systemic corticosteroids (SCS), and/or contraindicate to or intolerance to SCS, and/or with prior surgery to nasal polyps
- •Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity at screening and at baseline.
- •Ongoing symptoms of nasal congestion/obstruction(NCS score of 2 or 3 at screening and at baseline).
- •Recorded use of intranasal corticosteroids for at least 4 weeks before screening
排除标准
- •Insufficient washout time for drugs that have an impact on the evaluation of efficacy and safety。
- •Concurrent disease that may interfere with the evaluation of safety and efficacy in subjects, or affect the risk- benefit evaluation of subjects. eg. specific ongoing nasal diseases, severe asthma, active infection, Severe cardiovascular disease, Severe laboratory test abnormalities.
研究组 & 干预措施
Experimental: GR1802
GR1802 injection 300mg every two weeks for 16-week treatment
干预措施: GR1802 injection (Biological)
Placebo Comparator: Placebo
Placebo every two weeks for 16-week treatment
干预措施: placebo (Biological)
结局指标
主要结局
Change From Baseline at Week 16 in Nasal Congestion/Obstruction Symptom(NCS) Severity Score
时间窗: at Week 16
Change from baseline in the NCS score. NCS score (0-3), higher score means worse nasal symptom.
Change From Baseline at Week 16 in Nasal Polyp Score
时间窗: at Week 16
NPS score ranges from 0-8. (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
次要结局
- Lund-Mackay score(at Week 16)
- Nasal Congestion/Obstruction Symptom score(NCS)(at Week 4, 8, 12, 24)
- University of Pennsylvania Smell Identification Test (UPSIT)(at Week 16)
- Pharmacokinetics(PK)(Baseline up to Week 24)
- Total Nasal Symptom Score(TNSS) score(at Week 16)
- Visual Analogue Scale (VAS) for Rhinosinusitis(at Week 16)
- Safety parameters(Baseline up to Week 24)
- Pharmacodynamics(PD)(at Week 16)
- Anti-drug antibodies(ADA)(Baseline up to Week 24)
- Proportion of subjects receiving rescue therapy for nasal polyps(Baseline up to Week 24)
- Time to the first response of NPS(Baseline up to Week 24)
- Bilateral endoscopic NPS(at Week 4, 8, 12, 24)