Phase
Condition
Allergy (Pediatric)
Allergies & Asthma
Allergy
Treatment
Stapokibart Injection
Placebo
Clinical Study ID
Ages 12-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Able to understand the study and voluntarily sign the Informed consent form.
Diagnosed Allergic Rhinitis according to the Criteria stated in the ChineseGuidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, RevisedEdition).
Subjects with asthma must be evaluated by the researcher as having a stablecondition.
Has a positive skin prick test (SPT) or positive antigen-specific serumimmunoglobulin E (IgE).
Exclusion
Exclusion Criteria:
Use of anti-interleukin 4 receptor alpha subunit (IL-4Rα) monoclonal antibody,thymic stromal lymphopoietin (TSLP) monoclonal antibody, anti-IgE monoclonalantibody, other monoclonal antibodies, or other biologics within 10 weeks or 5half-lives (whichever is longer) prior to the screening visit.
Use of any investigational product within 4 weeks prior to the screening visit orplanning to participate in other clinical studies during this study.
Forced expiratory volume in 1 second (FEV1) ≤ 50% of the predicted value during thescreening/run-in period.
Have acute sinusitis, nasal infection, or upper respiratory tract infection atscreening or within 2 weeks prior to screening.
Have received a live-attenuated vaccine within 12 weeks prior to randomization orplanning to receive one during the study.
Study Design
Study Description
Connect with a study center
Beijing Tongren Hospital, CMU
Beijing, Beijing
ChinaActive - Recruiting
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