NCT05575037进行中（未招募）2 期
Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease: MARINER
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Nasal fluid levels of LTE4
研究概览
简要总结
The overall aim of the study is to determine the clinical efficacy and mechanisms of action of anti-IL-4a (dupilumab) as treatment for patients with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) and Aspirin-Exacerbated Respiratory Disease (AERD).
详细描述
The protocol involves an 8-week study of dupilumab in patients with CRSwNP and/or AERD. Participants will have 4 total doses of dupilumab administered, with each dose administered every 2 weeks. There will be full clinical assessments and biospecimen collections at Baseline (Visit 1), Week 2 (Visit 2), and Week 8 (Visit 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •History of AERD, defined as meeting the diagnostic triad with:
- •History of physician-diagnosed asthma and
- •History of physician-diagnosed nasal polyposis and
- •History of pathognomonic reactions to aspirin or other nonselective COX inhibitors.
- •Visible nasal polyps bilaterally on otoscope physical exam at the time of screening.
- •Evidence of sense of smell impairment, with a University of Pennsylvania Smell Identification Test (UPSIT) score of <
- •Stable asthma (no glucocorticoid burst for at least 4 weeks prior to Visit 1, and no hospitalizations or ER visits for asthma for at least the prior 3 months).
- •Consistent (daily) use of an intranasal steroid for at least 4 weeks prior to Screening.
- •No current smoking (not more than one instance of smoking in the last 3 months).
- •For females: Practicing FDA-approved methods of birth control for the duration of the study. Female participants of childbearing potential must have a negative pregnancy test upon study entry.
排除标准
- •Use of investigational drugs within 12 weeks of Screening.
- •Use of any biologic agent within 4 months prior to Screening.
- •Use of systemic (enteral or injected) glucocorticoids within 4 weeks prior to Screening.
- •History of any sinonasal surgery within 4 months prior to Screening
- •Current use of zileuton
- •Current use of high-dose aspirin therapy (no more than 325 mg aspirin per day will be allowed)
- •Pregnant, nursing, or planning to become pregnant
- •Note: Other inclusion and exclusion criteria apply.
研究组 & 干预措施
Dupilumab
Experimental
Subjects will receive dupilumab (300mg every-other-week for 8 weeks).
干预措施: Dupilumab (Drug)
结局指标
主要结局
Nasal fluid levels of LTE4
时间窗: At Week 8 (Visit 3)
The nasal fluid levels of LTE4 will be measured at week 8 and will serve as a surrogate biomarker of respiratory mast cell activation or burden.
次要结局
- Nasal fluid levels of albumin(At Week 8 (Visit 3))
- Sense of smell - University of Pennsylvania Smell Identification Test (UPSIT)(At Week 8 (Visit 3))
- Rhinoscopic Total Polyp Score (TPS)(At Week 8 (Visit 3))
- Quality of life - 22-Item Sino-Nasal Outcome Test (SNOT-22)(At Week 8 (Visit 3))
- Lung function - Forced Expiratory Volume 1 (FEV1)(At Week 8 (Visit 3))
- Asthma control - Asthma Control Questionnaire-6 (ACQ-6)(At Week 8 (Visit 3))
- Number of treatment-related adverse events (AEs) and serious adverse events (SAEs) leading to study drug discontinuation(At Week 8 (Visit 3))
- Rhinoscopic Total Polyp Score (TPS)(At Week 8 (Visit 3))
- Nasal fluid levels of albumin(At Week 8 (Visit 3))
- Sense of smell - University of Pennsylvania Smell Identification Test (UPSIT)(At Week 8 (Visit 3))
- Peak Nasal Inspiratory Flow (PNIF)(At Week 8 (Visit 3))
- Quality of life - 22-Item Sino-Nasal Outcome Test (SNOT-22)(At Week 8 (Visit 3))
- Lung function - Forced Expiratory Volume 1 (FEV1)(At Week 8 (Visit 3))
- Asthma control - Asthma Control Questionnaire-6 (ACQ-6)(At Week 8 (Visit 3))
- Number of treatment-related adverse events (AEs) and serious adverse events (SAEs) leading to study drug discontinuation(At Week 8 (Visit 3))
研究者
Tanya Laidlaw, MD
Associate Professor of Medicine
Brigham and Women's Hospital
研究点 (1)
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