NCT04709575已完成3 期
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Anti-Bet v 1 Monoclonal Antibodies to Reduce Symptoms of Seasonal Allergic Rhinitis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 353
- 试验地点
- 1
- 主要终点
- Combined Symptom and Medication Score (CSMS) in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
研究概览
简要总结
The primary objective is to assess the reduction of allergic symptoms as measured by combined symptom and medication score (CSMS) during birch pollen season after a single dose of REGN5713-5714-5715 versus 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Participation in a prior REGN5713-5714-5715 clinical trial
- •Recurrent or chronic rhinitis or sinusitis not associated with birch pollen season, or due to daily contact with other allergens causing symptoms that are expected to coincide with birch pollen season, as assessed by the investigator
- •Participants who anticipate major changes in allergen exposure in their home or work environments that are expected to coincide with the study assessments as assessed by the investigator
- •Persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections (at the discretion of the investigator) within 4 weeks prior to screening visit. Participants may be re-evaluated for eligibility after symptoms resolve
- •Documentation of active SARS-CoV-2 infection, as defined in the protocol
- •A clinical history of asthma with 2 or more asthma exacerbations requiring hospitalizations or systemic corticosteroids in the previous year
- •History of birch allergy immunotherapy as defined in the protocol
- •Use of anti-IgE or other biological therapy in treatment of asthma or allergy within 6 months prior to screening
- •NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
研究组 & 干预措施
REGN5713-5714-5715
Experimental
REGN5713-5714-5715 administered subcutaneously
干预措施: REGN5713 (Drug)
REGN5713-5714-5715
Experimental
REGN5713-5714-5715 administered subcutaneously
干预措施: REGN5714 (Drug)
REGN5713-5714-5715
Experimental
REGN5713-5714-5715 administered subcutaneously
干预措施: REGN5715 (Drug)
Placebo Only
Placebo Comparator
Placebo matching REGN5713-5714-5715 administered subcutaneously
干预措施: Placebo (Drug)
结局指标
主要结局
Combined Symptom and Medication Score (CSMS) in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
时间窗: Until the end of Birch Pollen Season, up to Week 16
The average CSMS will be calculated based on daily symptom score and daily medication score recorded over the duration of the birch pollen season (BPS). CSMS is calculated by adding the Daily Medication Score (DMS) and Total Symptom Score (TSS) together, with scores ranging between 0 (none) and 38 (severe).
次要结局
- Total Symptom Score (TSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo(Until the end of Birch Pollen Season, up to Week 16)
- Total Nasal Symptom Score (TNSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo(Until the end of Birch Pollen Season, up to Week 16)
- Serum Concentration of REGN5715 Over the Study Duration(Up to Day 127)
- Total Ocular Symptom Score (TOSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo(Until the end of Birch Pollen Season, up to Week 16)
- Daily Medication Score (DMS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo(Until the end of Birch Pollen Season, up to Week 16)
- Serum Concentration of REGN5713 Over the Study Duration(Day 0, Day 56, Day 112)
- Serum Concentration of REGN5714 Over the Study Duration(Up to Day 127)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Throughout the Study(Up to Day 127)
- Number of Participants With Serious TEAEs Throughout the Study(Up to Day 127)
- Change From Baseline to the End of Study in Birch SPT Mean Wheal Diameter in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo(Baseline through Day 127)
- Percent Change From Baseline to the End of Study in Birch SPT Mean Wheal Diameter in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo(Baseline through Day 127)
- Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5714 Throughout the Study(Up to Day 127)
- Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5715 Throughout the Study(Up to Day 127)
- Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5713 Throughout the Study(Up to Day 127)
- Number of "Well Days"(Until the end of Birch Pollen Season, up to Week 16)
研究者
研究点 (1)
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