The Efficacy and Safety of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis Under Conventional Treatment: A Randomized, Double-Blind, Placebo-controlled Investigator Initiated Trial.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period.
研究概览
简要总结
Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects meet the diagnosis of SAR which has been prevalent for at least 2 years, and: standard treatment regimen for SAR was ineffective or subjective symptom control was unsatisfactory in the subject; positive test for at least one allergen associated with the development of SAR; pre-baseline symptom episodes of ≥ 4 days/week and a baseline TNSS of ≥ 6 points.
- •Consent to highly effective contraception
排除标准
- •Other nasal comorbidities or co-morbidities/states that may be present at the time of screening；
- •It is expected that subjects' exposure to allergens in their home or work environments may change significantly during the study period.
- •Patients with asthma requiring stable use of inhaled controlled medications;
- •Previous or current malignant tumor within 5 years prior to screening;
- •Presence of other acute or chronic diseases or abnormal laboratory tests at the time of screening that, in the investigator's assessment, may have a more serious impact on the efficacy or safety assessment of the subject;
- •Live/live attenuated vaccine within 3 months prior to baseline;
- •Subjects with very limited outdoor activity during the daytime, as inferred from their regular daily routine;
- •Unwillingness or inability to comply with the permitted and prohibited medication/treatment specifications of the study, inability to meet the pre-randomization drug elution cycle specified in the protocol;
- •Women who are pregnant or breastfeeding;
- •History of alcohol or drug abuse within 3 months prior to screening.
结局指标
主要结局
Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period.
时间窗: week 4
The Total Nasal Symptom Score (TNSS) is the sum of the four symptom scores of runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3.
次要结局
未报告次要终点
研究者
Zheng Liu ENT
Head of Otolaryngology, Principal Investigator, Clinical Professor
Tongji Hospital