A 28-Day Study Evaluating the Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adult Subjects 50 Years of Age and Older With Ragweed-Induced Rhinoconjunctivitis (Protocol No. P06081)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 203
- 主要终点
- The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs)
研究概览
简要总结
The purpose of this study was to assess the safety and tolerability of a ragweed allergy immunotherapy tablet (AIT) administered sublingually (under-the tongue) in subjects 50 years of age and older with ragweed-induced rhinoconjunctivitis, with or without asthma.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be 50 years of age or older, of either sex, and of any race/ethnicity.
- •Subject must have a clinical history of ragweed-induced allergic rhinoconjunctivitis with or without asthma.
- •Subject must have a positive skin prick test response to Ambrosia artemisiifolia at the Screening Visit
- •Subject must have a forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at the Screening Visit and at Randomization.
- •A subject's clinical laboratory tests, electrocardiogram (ECG) and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator.
排除标准
- •Subject with asthma who requires inhaled corticosteroids for the treatment of their asthma during the study period.
- •Subject requiring anti-allergy medications during the time period from randomization to study completion.
- •Subject who has received an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms).
- •Subject with a history of anaphylaxis with cardiorespiratory symptoms.
- •Subject with a history of chronic urticaria or angioedema.
- •Subject with current severe atopic dermatitis.
- •Female subject who is breastfeeding, pregnant, or intending to become pregnant.
- •Subject with a history of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (IMPs) (except for Ambrosia artemisiifolia), or self-injectable epinephrine.
- •Subject with a history of self-injectable epinephrine use.
研究组 & 干预措施
Placebo
Matching placebo tablet sublingual, once daily
干预措施: Placebo (Drug)
SCH 39641 6 Amb a 1-U
6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an AIT, sublingual, once daily
干预措施: SCH 39641 (Biological)
SCH 39641 12 Amb a 1-U
12 Amb a 1-U in an AIT, sublingual, once daily
干预措施: SCH 39641 (Biological)
结局指标
主要结局
The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs)
时间窗: Up to Day 42
Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with treatment-emergent AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.
次要结局
- Proportion of Participants Reporting Oral Pruritus(Up to Day 42)
- Proportion of Participants Reporting Ear Pruritus(Up to Day 42)
- Proportion of Participants Reporting Throat Irritation(Up to Day 42)
- Proportion of Participants Reporting Mouth Oedema(Up to Day 42)
- Proportion of Participants Who Discontinued Due to Adverse Events.(Up to Day 28)