A Clinical Study on the Efficacy and Safety of Sublingual Film for Dermatophagoides Pteronyssinus in Chinese Adult Patients With Dust Mite Allergic Rhinitis - A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 9
- 主要终点
- daily combined scores of rhinitis symptoms and medication
研究概览
简要总结
To evaluate the efficacy and safety of different doses of Sublingual Film for Dermatophagoides Pteronyssinus in adult patients with Dust Mite Allergic Rhinitis via a randomized, double-blind, placebo-controlled Phase II clinical trial, and to explore the optimal dose for the Phase III clinical trial.
This study consisted of 5 groups, including 4 treatment groups with different doses and 1 placebo group.
Subjects used Sublingual Film for Dermatophagoides pteronyssinus or a placebo (a look-alike substance that contains no drug) for approximately 52 weeks, and recorded in E-diary the usage of the investigational product, adverse events, concomitant medications, and the use of rescue medication.
Four efficacy data collection periods (each lasting 4 weeks) were scheduled during the trial: Week 13-16, Week 25-28, Week 37-40, and Week 49-52.
During these efficacy data collection periods, subjects were required to complete E-diary to record rhinitis symptoms (conjunctivitis symptoms were recorded simultaneously for subjects with concurrent conjunctivitis).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 60 (including 18 and 60), male or female;
- •Diagnosed with allergic rhinitis (documented by medical records/prescriptions/specific IgE test reports for allergens, etc.) for ≥ 6 months prior to screening;
- •Skin Prick Test (SPT) during screening shows a maximum wheal diameter of ≥ 5 mm for Dermatophagoides pteronyssinus;
- •Dermatophagoides pteronyssinus (or mite mix containing Dermatophagoides pteronyssinus) specific immunoglobulin E (IgE) levels of class 3 or higher during screening;
- •Pulmonary function test (routine spirometry) during screening shows FEV₁ % predicted ≥ 70%;
- •Total daily nasal symptom score ≥ 6 for at least 5 days out of the last consecutive 10 days within the 14 days prior to randomization;
- •Use of symptomatic medication for allergic rhinitis on at least 5 days out of the last consecutive 10 days within the 14 days prior to randomization;
- •Subjects have fully understood the purpose, nature, methods and potential adverse reactions of the trial, voluntarily participate in this clinical trial, and are able to provide written informed consent prior to initiation of any study procedures;
- •Subjects are able to communicate well with the investigators and understand and comply with all requirements of this clinical trial.
排除标准
- •Subjects have a history of seasonal allergic rhinitis, and the onset season may overlap with the baseline or primary efficacy data collection period;
- •Subjects have a serum specific IgE test result of Grade ≥ 2 for common allergens such as pollen, animal dander, and mold; and in the investigator's judgment, the subject has a history of allergen exposure/contact and will be exposed to/come into contact with the relevant allergens during the trial;
- •Currently suffering from nasal diseases such as chronic sinusitis or nasal polyps that, in the investigator's judgment, may affect the evaluation of efficacy;
- •Received beta-blockers or angiotensin-converting enzyme (ACE) inhibitors prior to dosing, with a washout period of less than 5 elimination half-lives of the respective drug;
- •Received mite-allergen and specific immunotherapy (including Subcutaneous Immunotherapy and Sublingual Immunotherapy) within 3 years prior to dosing, or is currently receiving any allergen-specific immunotherapy;
- •Received Anti-IgE antibody therapy (e.g., omalizumab) or other biological agents affecting IgE production (e.g., dupilumab, spicabiosen) prior to dosing, with a washout period of less than 5 elimination half-lives of the respective drug;
- •Received systemic immunosuppressive therapy within 14 days prior to dosing;
- •Currently suffering from oral diseases such as oral ulcers, or upper gastrointestinal diseases including esophagitis and dysphagia that, in the investigator's judgment, may affect medication compliance;
- •Has a history of severe allergic reaction/anaphylaxis;
- •Experienced an asthma exacerbation requiring emergency treatment or hospitalization within 1 year prior to screening; or had > 2 episodes of nocturnal awakening due to asthma within 1 month prior to screening; or used inhaled short-acting beta2 agonists > 2 times per week;
- •Has a history of irreversible obstructive respiratory disease, severe cardiovascular disease, severe autoimmune disease, immunodeficiency disorder, or malignant tumor;
- •Lactating female, positive pregnancy test, or female of childbearing potential unwilling to use effective contraception during the trial;
- •Participated in another clinical trial and received investigational medicinal product within 1 month prior to screening;
- •Any other condition that, in the investigator's opinion, renders the subject unsuitable for participation in this study.
研究组 & 干预措施
Placebo
Subjects receive a placebo every day for 52 weeks
干预措施: Sublingual Film for Dermatophagoides pteronyssinus placebo (Biological)
Sublingual Film for Dermatophagoides pteronyssinus
Subjects receive a Sublingual Film for Dermatophagoides pteronyssinus every day for 52 weeks.
干预措施: Sublingual Film for Dermatophagoides pteronyssinus (Biological)
结局指标
主要结局
daily combined scores of rhinitis symptoms and medication
时间窗: Week 49-52
the daily combined scores of medication and rhinitis symptoms (ranging from 0 to 6); which was calculated as the combined score of daily average scores of 4 rhinitis symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing) and the daily rescue medication score. Higher scores indicate more severe symptoms and a worse outcome.
次要结局
- daily combined scores of rhinitis symptoms and medication(Week 13-16; Week 25-28; Week 37-40)
- daily total nasal symptom score(Week 13-16; Week 25-28; Week 37-40; Week 49-52)
- daily Rescue Medication Scores(Week 13-16; Week 25-28; Week 37-40; Week 49-52)
- daily combined scores of medication and rhinoconjunctivitis symptoms(Week 13-16; Week 25-28; Week 37-40; Week 49-52)
- adverse event(Week 1-52)