A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of TOLAMBA™ in the Control of Symptoms of Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Model
概览
- 阶段
- 2 期
- 干预措施
- Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate
- 疾病 / 适应症
- Rhinitis, Allergic, Seasonal
- 发起方
- Dynavax Technologies Corporation
- 入组人数
- 271
- 试验地点
- 6
- 主要终点
- Total Nasal Symptom Score (TNSS)
- 状态
- 已完成
- 最后更新
- 7年前
概览
简要总结
This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study. After passing the initial Screening Visit, subjects will be in the environmental exposure chamber(EEC), a room with a controlled amount of ragweed pollen, for 4 hours each day on 4 consecutive days. At the last visit, subjects who have achieved a minimum Total Nasal Symptom Score (TNSS) will be randomized to receive either TOLAMBA or placebo treatments. Subjects will receive 6 weekly subcutaneous (under the skin) injections of the study drug. About three weeks after the last injection, subjects will be asked to be in the EEC for 2 consecutive days (Visits 11 and 12, Days 60 and 61). Approximately 3 weeks after Visit 12 (Day 61), the subjects will again be in the EEC for 4 consecutive days (Visits 13-16, Days 82-85).
During all EEC visits, the subjects will be exposed to ragweed pollen at an average concentration of 3500 ± 500 pollen grains per cubic meter. Each EEC visit will last 4 hours. During each EEC visit, patients will be asked to record symptom scores for nasal and non-nasal symptoms at scheduled time points.
The total duration of a subject's participation in this study is expected to be a minimum of 85 days.
详细描述
Ragweed allergy is the most common seasonal allergy in North America. Allergen immunotherapy is a therapeutic option for patients who have allergy symptoms that cannot be adequately controlled by avoidance of the allergen or medication. It may also be appropriate for those who cannot tolerate their medications due to side effects or have difficulties with medication compliance. This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study. After passing the initial Screening Visit, subjects will be in the environmental exposure chamber(EEC), a room with a controlled amount of ragweed pollen, for 4 hours each day on 4 consecutive days. At the last visit, subjects who have achieved a minimum Total Nasal Symptom Score (TNSS) will be randomized to receive either TOLAMBA or placebo treatments. Subjects will receive 6 weekly subcutaneous (under the skin) injections of the study drug. About three weeks after the last injection, subjects will be asked to be in the EEC for 2 consecutive days (Visits 11 and 12, Days 60 and 61). Approximately 3 weeks after Visit 12 (Day 61), the subjects will again be in the EEC for 4 consecutive days (Visits 13-16, Days 82-85). During all EEC visits, the subjects will be exposed to ragweed pollen at an average concentration of 3500 ± 500 pollen grains per cubic meter. Each EEC visit will last 4 hours. During each EEC visit, patients will be asked to record symptom scores for nasal and non-nasal symptoms at scheduled time points. The total duration of a subject's participation in this study is expected to be a minimum of 85 days. Comparison: Allergy symptoms of subjects treated with TOLAMBA™ compared with subjects treated with placebo.
研究者
入排标准
入选标准
- •Is willing and able to give signed informed consent, and must have provided this consent.
- •Has a clinical history of seasonal allergic rhinitis with seasonal nasal allergy symptoms during each of the last 2 ragweed allergy seasons.
- •Has documentation of a positive skin test to ragweed allergen within 12 months of screening.
- •Has minimum qualifying symptom scores at the last visit of the Pre-Treatment EEC sessions (Visit 5, Day 4).
- •If female of childbearing potential, is not pregnant and is consistently using an acceptable birth control method.
- •Is normally active and otherwise judged to be in good health on the basis of medical history, physical examination and routine laboratory tests.
排除标准
- •A woman who is pregnant, breastfeeding, or planning a pregnancy.
- •Has a history of more than mild asthma that requires the use of a daily inhaled or oral corticosteroid, leukotriene inhibitor, or cromolyn; or a daily inhaled short or long acting β-agonist.
- •Has had any hospital admissions for asthma, a recent (within the past 12 months)asthma exacerbation that required either oral or inhaled corticosteroids, or a prior history of unstable asthma.
- •Has received immunotherapy within the last 2 years that has contained ragweed pollen extract.
- •Has previously participated in a clinical trial with TOLAMBA or another ragweed-based immunotherapy.
- •Has received immunotherapy for any allergens within 30 days prior to Visit
- •Has the need for use of antihistamines or corticosteroids on a regular basis (systemic or topical).
- •Has received anti-immunoglobulin E (IgE) antibody (Xolair®) within the past 12 months.
- •Is currently taking monoamine oxidase (MAO) inhibitors.
- •Has taken any systemic corticosteroids, immunomodulators, or immune suppressive medications within 4 weeks prior to Visit
研究组 & 干预措施
TOLAMBA™
干预措施: Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate
Histamine
Histamine simulates mild redness/swelling effect seen with active comparator, TOLAMBA™. Prevents study staff from easily identifying subjects who received active comparator.
干预措施: Histamine
结局指标
主要结局
Total Nasal Symptom Score (TNSS)
时间窗: 3 months
次要结局
- Total Non-Nasal Symptom Score (TNNSS)(3 months)
- quality of life questionnaire(3 months)
- Total Symptom Score (TSS)(3 months)