jRCT2041250027招募中不适用
TO-209 Phase III Clinical Trial - Investigation of Efficacy and Safety in Patients with Grass Pollinosis -
Torii Pharmaceutical Co.,Ltd0 个研究点目标入组 760 人开始时间: 2025年6月6日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 760
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 5age old over 至 64age old under（—）
- 性别
- All
入选标准
- •Men and women aged >= 5 years to < 65 years on the day of informed consent
- •Patients who meet either A and/or B in these tests conducted on the first day of observation (Visit 1)
- •"Phleum pratense (Timothy) pollen-specific IgE antibody test >= Class 2" and "positive skin prick test (Timothy)
- •"Orchard pollen-specific IgE antibody test >= Class 2" and "positive skin prick test (Orchard)".
- •Patients who experienced any moderate to severe nasal symptoms of nasal discharge, nasal congestion, sneezing, or pruritus (with a total nasal symptom score of >= 7) as well as any mild to severe ocular symptoms of foreign body sensation/hyperemia/pruritus in the eye or lacrimation (with a total ocular symptom score of >= 1) in locations with weeds, such as dry riverbeds, fields, farmlands, and vacant lots, during the grass pollen season (Hokkaido: Jun, Tohoku, Kanto, Chubu, Kinki, Chugoku, Shikoku, Kyushu: May-Jun) for >= 2 years consecutively, including the year of the starting day of observation (Visit 1), and who required drug therapy.
排除标准
- •Patients with specific IgE antibody test results of Class 5 or higher for any of the following: Japanese cypress, alder, white birch, ragweed, Dermatophagoides pteronyssinus, dog dander, cat dander, cockroach, moth, Candida, Aspergillus, and Alternaria measured on the starting day of observation (Visit 1)
- •Patients with specific IgE antibody test results of Class 2-4 for dog dander and cat dander measured on the starting day of observation (Visit 1) who experienced allergic rhinitis due to the antigens
- •Patients with specific IgE antibody test results of Class 2-4 for dog dander and cat dander measured on the starting day of observation (Visit 1) who showed no symptoms of allergic rhinitis due to the antigens while being exposed to the animals on a daily basis (e.g., have a dog(s)/cat(s) at home, work at a pet shop)
- •Patients having daily contact with the pet(s) fed by timothy and/or orchard
- •Patients who experienced seasonal allergic rhinitis or conjunctivitis symptoms caused by other allergens during the grass pollen season (between May and June) and required medication
- •Patients with comorbidities such as drug-induced rhinitis, vasomotor rhinitis, or non-allergic rhinitis
- •Patients with following asthma;
- •Asthma requiring high daily doses of inhaled corticosteroids within 6 months prior to the randomisation (Visit 2)
- •Any clinical deterioration of asthma (i.e. asthma exacerbation) that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 6 months prior to randomisation (Visit 2)
- •Patients who received specific or non-specific immunotherapy for grass pollinosis, as indicated below:
- •Patients who received specific immunotherapy for grass pollinosis for at least 1 month within 5 years before the starting day of observation (Visit 1)
- •Patients who received non-specific immunotherapy between 5 years before the starting day of observation (Visit 1) and the starting day of observation (Visit 1)
- •Patients who have initiated specific immunotherapy for allergic symptoms caused by mite allergens within 1 year before the starting day of observation (Visit 1)
- •Patients who have initiated specific immunotherapy for allergic symptoms caused by Japanese cedar pollen in 2025
结局指标
主要结局
-
Average daily Total combined rhinoconjunctivitis symptom score and rhinoconjunctivitis medication score during period A
次要结局
- Average daily Total combined rhinoconjunctivitis symptom score and rhinoconjunctivitis medication score during period B(period B)
- Average daily rhinoconjunctivitis score during period A, period B(period A, period B)
- Average daily rhinoconjunctivitis medication score during period A, period B(period A, period B)
- Average daily rhinitis score during period A, period B(period A, period B)
- Average daily rhinitis medication score during period A, period B(period A, period B)
- Average daily Total combined rhinitis score during period A, period B(period A, period B)
- Average daily conjunctivitis score during period A, period B(period A, period B)
- Average daily conjunctivitis medication score during period A, period B(period A, period B)
- Average daily Total combined conjunctivitis score during period A, period B(period A, period B)
- JRQLQ No.1 (23-May-2026, 23-Jun-2026)(23-May-2026, 23-Jun-2026)
- Physician's and subject's global evaluation
研究者
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