Efficacy and Safety of Sublingual Immunotherapy for Allergic Rhinitis Due to House Dust Mites

Exclusion Criteria

• •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.