A Randomized, Placebo-controlled, Parallel Panel Study to Assess the Effects of REGN3500, Dupilumab, and Combination of REGN3500 Plus Dupilumab on Markers of Inflammation After Bronchial Allergen Challenge in Patients With Allergic Asthma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 5
- 主要终点
- Difference in bronchial allergen challenge (BAC)-induced changes in sputum inflammatory markers in individuals treated with REGN3500, dupilumab and the combination of REGN3500 plus dupilumab or placebo
研究概览
简要总结
To assess the effects of REGN3500, dupilumab, and REGN3500 plus dupilumab, compared with placebo, on changes in inflammatory gene expression signatures in sputum induced after a bronchial allergen challenge (BAC) in adults with mild allergic asthma, at week 4 after treatment initiation compared with those at screening.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged between 18 and 60 years
- •Has a Body Mass Index {BMI) of 17 to 33 kg/m2 at pre-study screening
- •Has a history of mild allergic asthma for at least 6 months
- •Is a non-smoker or ex-smoker for at least 12 months
排除标准
- •Has a history of life-threatening asthma
- •Has been hospitalized or has attended the emergency room for asthma in the 12 months prior to screening
- •Has a history of severe allergies or history of an anaphylactic reaction
- •Has a history of drug or alcohol abuse within a year prior to the screening visit
- •Note: other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
REGN3500
REGN3500: masked and randomized dosing regimen per protocol (part 1 only)
干预措施: REGN3500 (Drug)
Dupilumab
Dupilumab: masked and randomized dosing regimen per protocol (part 1 only)
干预措施: Dupilumab (Drug)
REGN3500 plus dupilumab
REGN3500 plus dupilumab: masked and randomized dosing regimen per protocol (part 1 only)
干预措施: REGN3500 (Drug)
REGN3500 plus dupilumab
REGN3500 plus dupilumab: masked and randomized dosing regimen per protocol (part 1 only)
干预措施: Dupilumab (Drug)
Placebo
Placebo: masked and randomized dosing regimen per protocol (part 1 only)
干预措施: Placebo (Drug)
Fluticasone propionate
Fluticasone propionate: open label dosing regimen per protocol (part 2 only)
干预措施: Fluticasone propionate (Drug)
结局指标
主要结局
Difference in bronchial allergen challenge (BAC)-induced changes in sputum inflammatory markers in individuals treated with REGN3500, dupilumab and the combination of REGN3500 plus dupilumab or placebo
时间窗: Screening (pre-treatment) to week 4 after treatment initiation
次要结局
- Difference in the BAC-induced changes in sputum inflammatory mRNA signature in individual patients treated with fluticasone(Screening (pre-treatment) to day 4 after treatment initiation)
- Serum concentration-time profile of REGN3500(Baseline to week 42)
- Incidence of Treatment Emergent Adverse Events (TEAEs)(Baseline to week 42)
- Serum concentration-time profile of REGN3500: AUClast (area under the curve to the last measurable concentration)(Baseline to week 42)
- Severity of TEAEs(Baseline to week 42)
- Serum concentration-time profile of REGN3500: Tmax (time at Cmax)(Baseline to week 42)
- Immunogenicity of REGN3500 and dupilumab(Baseline to week 42)
- Serum concentration of total IL-33 after single IV dose(Up to Week 42)