NCT00670384撤回2 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study of Sublingual Immunotherapy in Adults Sensitized to the Standardized Allergenic Extract, Short Ragweed (Ambrosia Artemisiifolia)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Average of Total Symptom Scores
研究概览
简要总结
The purpose of this study is to identify an effective dose of allergen-specific immunotherapy for short ragweed (Ambrosia artemisiifolia) administered by an oral/sublingual route.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Previous allergen immunotherapy (subcutaneous immunotherapy (SCIT), oral immunotherapy, sublingual immunotherapy (SLIT), or recombinant peptide) for short ragweed within 24 months of the Screening Visit.
- •History of severe allergic reaction requiring medical intervention.
- •Intolerance of or severe allergic reaction to previous immunotherapy (SCIT, oral immunotherapy, SLIT, or recombinant peptide).
- •Allergy to any of the non-antigen ingredients in the study drug formulation, including, but not limited to, Food, Drug and Cosmetic (FD&C) Yellow #5, sodium chloride, sodium bicarbonate, and glycerine.
- •History of asthma requiring daily medication.
- •Subjects receiving anti-IgE monoclonal antibodies.
- •Congenital immune deficiency or acquired immune suppression. Causes of acquired immune suppression may include, but are not limited to, systemic illnesses such as malignancy and infection, the use of medications such as corticosteroids and chemotherapeutic agents, and radiation therapy.
- •History of organ transplant, hematologic malignancy, autoimmune disease, myocardial infarction, or congestive heart failure.
- •History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, psychiatric, or cardiovascular disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- •Inability or unwillingness to stop using drugs that may inhibit the wheal-and-flare reaction or rhinitic response prior to the study and for the duration of dosing CTM (with the exception of protocol-specified rescue medications provided by the study site for use after Study Day 0).
- •Inability or unwillingness to stop using drugs that may inhibit the ability to treat a severe allergic adverse event. This includes, but is not limited to: beta blockers such as atenolol (Tenormin), metoprolol (Lopressor, Toprol-XL) and propranolol (Inderal, Inderal LA) for 14 days prior to Study Day 0 and for the duration of the study
- •Female subjects who are trying to conceive, are pregnant, or are lactating.
- •Positive serum pregnancy test at screening or a positive human chorionic gonadotropin (HCG) urine test on Study Day 0 prior to administration of study drug for women of childbearing potential.
- •Positive blood screen for HIV, Hepatitis B surface antigen (HbSAg), or Hepatitis C.
- •History of alcohol or drug abuse within the year prior to the Screening Visit, or current evidence of substance dependence or abuse.
- •Participation in a clinical trial or receipt of a non-FDA approved therapy within 30 days prior to the Screening Visit.
结局指标
主要结局
Average of Total Symptom Scores
时间窗: 20 weeks
次要结局
未报告次要终点
研究者
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