NCT07313917尚未招募2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase Ⅱ Clinical Trial to Evaluate the Efficacy and Safety of LP-003 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Longbio Pharma1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年1月20日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from baseline in Nasal Polyps Score (NPS) at Week 24
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial. Its primary objective is to explore and preliminarily evaluate the efficacy and safety of LP-003 Injection in the treatment of participants with chronic rhinosinusitis with nasal polyps (CRSwNP), as well as to investigate its pharmacokinetic (PK), pharmacodynamic (PD) profiles, and immunogenicity.
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
- •Capable of understanding the study and voluntarily signing the Informed Consent Form (ICF);
- •Aged 18 to 75 years (inclusive) at the time of signing the ICF, regardless of gender;
- •Diagnosis of bilateral chronic rhinosinusitis with nasal polyps (CRSwNP);
- •Persistence of the following symptoms for ≥ 4 weeks prior to the screening/run-in period:
- •Nasal congestion;
- •Any one of the other symptoms: mucoid or mucopurulent nasal discharge, head and facial distension/pain, hyposmia or anosmia;
- •Nasal Polyp Score (NPS) ≥ 5 points, with each nasal cavity scoring at least ≥ 2 points during the screening/run-in period and prior to randomization;
- •Participants report moderate to severe nasal congestion during the screening/run-in period and prior to randomization:
- •Nasal Congestion Score (NCS) of 2 or 3 points at the screening/run-in period (Visit 1, V1);
- •Mean weekly NCS ≥ 2 points prior to randomization;
- •With bilateral CRSwNP despite prior treatment with systemic corticosteroids (SCS) such as oral corticosteroids (OCS) within 2 years prior to screening; and/or has contraindications to SCS treatment or is intolerant to SCS; and/or has undergone nasal polypectomy within 6 months prior to screening, with persistent bilateral CRSwNP.
- •Has been on a stable dosage of intranasal corticosteroids (INCS) for at least 4 weeks prior to screening;
- •Demonstrates ≥80% adherence to mometasone furoate nasal spray (MFNS) administration during the run-in period (with a minimum of 14 days of use).
排除标准
- •Concurrent other nasal diseases or nasal symptoms;
- •Acute upper respiratory tract infection at screening, which the investigator assesses may affect nasal symptom scoring;
- •Severe infection requiring intravenous antibiotics and/or hospitalization within 4 weeks prior to randomization that has not yet resolved, or active infection requiring oral antibiotics within 2 weeks prior to randomization that has not yet resolved; the investigator assesses that enrollment of the participant may pose uncontrollable risks;
- •Concurrent active parasitic infection (e.g., helminths) or suspected parasitic infection;
- •Known or suspected history of immunosuppression, including a history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis); or participants with a history of such infections that have resolved but are assessed by the investigator as likely to recur frequently;
- •Any severe or unstable disease that the investigator believes may affect the participant's safety during the study and/or hinder the participant from completing the study;
- •Has any severe or unstable disease that, in the investigator's judgment, may affect the safety of the trial participant during the study and/or preclude the participant from completing the study, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, autoimmune, hematological, or psychiatric disorders.
- •Current or prior receipt of the following treatments:
- •Use of traditional Chinese medicine (TCM) or proprietary Chinese medicines for chronic rhinosinusitis within 1 week prior to screening;
- •Use of medium- or short-acting systemic corticosteroids (SCS) within 4 weeks prior to randomization, or long-acting SCS within 6 weeks prior to randomization;
- •Receipt of any systemic monoclonal antibody therapy [e.g., Stapokibart, Dupilumab, Mepolizumab, Omalizumab, Tezepelumab, etc.] within 10 weeks prior to randomization or within 5 half-lives (whichever is longer);
- •Use of systemic immunosuppressants within 4 weeks prior to randomization or within 5 half-lives (whichever is longer);
- •Initiation of leukotriene receptor antagonist (LTRA) therapy within 4 weeks prior to randomization (participants who have been receiving stable-dose LTRA therapy for at least 4 weeks prior to randomization are eligible for enrollment);
- •For participants with concurrent asthma, the forced expiratory volume in 1 second (FEV1) as a percentage of predicted value ≤ 50% during the screening/run-in period;
- •Known allergy or intolerance to any component of the investigational product and/or mometasone furoate nasal spray;
- •Pregnant or lactating females;
- •Any other conditions that the investigator deems inappropriate for the participant to participate in the study.
研究组 & 干预措施
LP-003 450 mg group
Experimental
Participants will receive subcutaneous injection of LP-003 Injection at a dose of 450 mg once every 12 weeks.
干预措施: LP-003 Injection (Biological)
Placebo
Placebo Comparator
Participants will receive subcutaneous injection of placebo Injection once every 12 weeks.
干预措施: Placebo of LP-003 (Biological)
LP-003 300 mg group
Experimental
Participants will receive subcutaneous injection of LP-003 Injection at a dose of 300 mg once every 12 weeks.
干预措施: LP-003 Injection (Biological)
结局指标
主要结局
Change from baseline in Nasal Polyps Score (NPS) at Week 24
时间窗: Week 24
NPS is a bilateral endoscopic assessment scale for nasal polyposis, where each nasal cavity is scored from 0 to 4. The total score is the sum of the left and right sides, ranging from 0 to 8, with higher scores indicating more severe nasal polyp disease.
Change from baseline in Nasal Congestion Score (NCS) at Week 24
时间窗: Week 24
The NCS is a patient-reported outcome measure using a 0-3 point Verbal Rating Scale (VRS). Patients rate their nasal congestion severity as 0 (no symptoms), 1 (mild symptoms), 2 (moderate symptoms), or 3 (severe symptoms). The total score ranges from 0 to 3, with higher scores indicating more severe nasal congestion.
次要结局
- Percentage of participants with a ≥2-point improvement in NPS from baseline(Up to approximately 56 weeks)
- Change from baseline in NPS at each assessment visit (excluding Week 24)(Up to approximately 56 weeks)
- Change from baseline in NCS at each assessment visit (excluding Week 24)(Up to approximately 56 weeks)
- Percentage of participants with a ≥1-point improvement in NPS from baseline(Up to approximately 56 weeks)
- Incidence of adverse events (AEs)(Up to approximately 56 weeks)
- Percentage of participants with a ≥1-point improvement in NCS from baseline(Up to approximately 56 weeks)
- Number of patients with anti-drug antibodies (ADA)(Up to approximately 56 weeks)
- Change from baseline in Total Score of 22-Items Sinonasal Outcome Test (SNOT-22)(Up to approximately 56 weeks)
- Serum concentrations of LP-003(Up to approximately 56 weeks)
研究者
研究点 (1)
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