A 28-Day Study Evaluating the Safety of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet (SCH 39641/MK-3641) Treatment in Ragweed Allergic Adults (Phase 3, Protocol No.P05751)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 914
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (AEs)
研究概览
简要总结
This study assessed the safety profile of short ragweed (Ambrosia artemisiifolia) in participants with ragweed-induced rhinoconjunctivitis with or without asthma. The primary objective was to compare treatment-emergent adverse events (AEs) for participants treated with short ragweed allergy immunotherapy tablet (AIT) with those treated with 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
- Double (Participant, Investigator)
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
- •Clinical history of physician-diagnosed ragweed-induced allergic rhinoconjunctivitis of 2 years duration or more, with or without asthma
- •Must have a positive skin prick test response to Ambrosia artemisiifolia
- •Must have a forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value
- •Clinical laboratory tests, electrocardiogram (ECG) and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor
- •Females of child-bearing potential must agree to use medically accepted methods of contraception
排除标准
- •Unstable asthma or has experienced an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids in previous 3 months
- •Received an immunosuppressive treatment within 3 months
- •History of anaphylaxis with cardio-respiratory symptoms.
- •History of chronic urticaria or angioedema
- •Current severe atopic dermatitis
- •Female subject who is breastfeeding, pregnant, or intending to become pregnant
- •Has received maintenance doses of immunotherapy with ragweed extract for ≥1 month within the last 5 years
- •History of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (IMPs) (except for Ambrosia artemisiifolia), or self-injectable epinephrine
- •Unable to or will not comply with the use of self-injectable epinephrine
- •Participating in any other clinical trial
研究组 & 干预措施
SCH 39641 12 Amb a 1-U
12 Units short ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) extract in an AIT, sublingual, once daily.
干预措施: SCH 39641 (Biological)
Placebo
Matching placebo tablet, sublingual, once daily.
干预措施: Placebo for SCH 39641 (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (AEs)
时间窗: Up to Day 35
Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number 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
- Number of Participants Reporting Oral Pruritus.(Up to Day 35)
- Number of Participants Reporting Mouth Oedema(Up to Day 35)
- Number of Participants Reporting Nasal Passage Irritation(Up to Day 35)
- Number of Participants Reporting Skin Pruritus(Up to Day 35)
- Number of Participants Reporting Throat Irritation(Up to Day 35)
- Number of Participants Reporting Eye Pruritus(Up to Day 35)
- Number of Participants Reporting Ear Pruritus(Up to Day 35)
- Number of Participants Who Discontinued Due to Treatment-emergent AEs(Up to Day 28)