EUCTR2020-004094-52-BE进行中（未招募）1 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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 353
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Documented or subject-reported history of birch pollen-triggered allergic rhinitis symptoms, with or without conjunctivitis, for at least 2 years
- •2. Positive SPT with birch pollen extract in the screening period, as defined in protocol
- •3. Positive Allergen-specific IgE (sIgE) tests for birch pollen and Bet v 1 in the screening period, as defined in the protocol
- •4. Willing and able to comply with clinic visits and study-related procedures
- •NOTE: Other protocol defined inclusion criteria apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Participation in a prior REGN5713-5714-5715 clinical trial
- •2. 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
- •3. Subjects who anticipate major changes in allergen exposure in their home or work environments that are expected to coincide with study assessments, per investigator discretion
- •4. 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. Subjects may be re-evaluated for eligibility after symptoms resolve
- •5. Documentation of active SARS-CoV-2 infection
- •Note: A subject with a documented, positive PCR or serology test for SARS-CoV-2 may
- •be enrolled, provided that the subject has:
- •Recovered from COVID-19 (all COVID-19-related symptoms and major clinical
- •findings which can potentially affect the safety of the patient should be resolved to
- •baseline), and
- •Had 2 negative results from a health authority-authorized nucleic acid amplification
- •(PCR) test for COVID-19 taken at least 48 hours apart
- •6. A clinical history of asthma with 2 or more asthma exacerbations requiring hospitalizations or systemic corticosteroids in the previous year
- •7. History of birch allergy immunotherapy, as defined in the protocol
- •8. Use of anti-IgE or other biological therapy in treatment of asthma or allergy within 6 months prior to screening
- •NOTE: Other protocol defined exclusion criteria apply
研究者
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