A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis.
Allergic Rhinitis
About this trial
This is an interventional treatment trial for Allergic Rhinitis
Eligibility Criteria
Key Inclusion Criteria: 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 Key Exclusion Criteria: 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.
Sites / Locations
- Tongji Hosptial affiliated to Tongji Medical college of Huazhong University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Interleukin-4 receptor responders 1
Interleukin-4 receptor responders 2
Placebo
Recombinant fully human anti-IL4Rα monoclonal antibody drug.
Recombinant fully human anti-IL4Rα monoclonal antibody drug.
Recombinant fully human anti-IL4Rα monoclonal antibody drug.