Seasonal allergic rhinitis (SAR)
Conditions
Interventions
Test group:Administer omalizumab a via injection
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years old, male or female; 2. Seasonal allergic rhinitis (SAR) that meets the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition), with a history of seasonal allergic rhinitis for at least 2 years; 3. Pollen-specific IgE level detected by Immuno CAP allergen sIgE detection system >=0.7 KU/L (results within one year before signing the ICF are acceptable); 4. At screening, 60IU/ml<=serum total IgE concentration<=1500IU/ml, body weight between 20kg~150kg; 5. Voluntarily sign the informed consent form, be willing to comply with the study protocol, and be able to complete the patient diary card on time;
Exclusion criteria
Exclusion criteria: 1.Allergy to omalizumab, excipients of the investigational drug, or other biologics; or a history of severe drug allergies or anaphylaxis; 2.Patients who have already developed symptoms of seasonal allergic rhinitis (e.g., sneezing, rhinorrhea, nasal itching, nasal congestion, ocular itching/foreign body sensation/redness, or tearing); 3.Patients with perennial allergic rhinitis sensitized to indoor allergens (e.g., dust mites, mold, or animal dander) with serum-specific IgE levels = 3.5 KU/L; 4.Nasal conditions (e.g., chronic rhinitis, chronic sinusitis) that, in the investigator’s judgment, may interfere with study results; 5.Patients who have undergone pollen allergen-specific immunotherapy within 5 years prior to screening; 6.Patients who have received other biologics for seasonal allergic rhinitis (e.g., omalizumab, spigelimab) within 6 months prior to screening; 7.Patients with psychiatric disorders or cognitive impairment who are unable to understand and comply with the study protocol or complete the diary card accurately; 8.Patients with severe hepatic or renal impairment: a) Liver function: Total bilirubin (TBIL) > 2× upper limit of normal (ULN); alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3×ULN; b) Renal function: Serum creatinine (Scr) > 1.5×ULN; 9.Pregnant or breastfeeding women; 10.Participation in another drug clinical trial and use of other investigational drugs within 3 months prior to screening; 11.Any other condition deemed by the investigator to potentially affect trial results or patient safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who develop symptoms of seasonal allergic rhinitis after the first dose.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Total Ocular Symptom Score (TOSS);;Mean change in individual ocular symptom scores (ocular itching/foreign body sensation/redness, tearing);Mean change in Total Nasal Symptom Score (TNSS);;Measurement of peripheral blood sulfidoleukotriene release (LTD4) using Cellular Allergen Stimulation Test (CAST)-ELISA;;Mean change in individual nasal symptom scores (rhinorrhea, nasal congestion, nasal itching, and sneezing);;Improvement in lung function (FEV1, FVC, and FEV1/FVC) from baseline (in seasonal allergic rhinitis patients with comorbid asthma).;Levels of peripheral blood inflammatory cytokines (IL-4, IL-5, IL-13);Mean change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score;Number of days without rescue medication use;Number of symptom-free days (nasal symptoms); | — |
Countries
China
Contacts
Public ContactZhi Yuxiang
Peking Union Medical College Hospital
Outcome results
None listed