Study on the Treatment of Adolescent Patients With Seasonal Allergic Rhinitis

Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens.

All participants will receive standard of care treatment as concomitant medications. Stapokibart or placebo will be administered as add-on therapy.

Inclusion criteria

• Age range: ≥12 years to <18 years
• Voluntarily sign the informed consent form.
• Seasonal allergic rhinitis has been prevalent for at least 2 years.Positive for allergens associated with seasonal allergic rhinitis.
• Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past.
• Weight≥40kg.
• Symptom severity scores for the season met the enrollment criteria.

Exclusion criteria

• Subjects who received anti-interleukin-4 receptor alpha(anti-IL-4Rα), anti-thymic stromal lymphopoietin(anti-TSLP), anti-immunoglobulin E(anti-IgE) monoclonal antibodies or other biologics within 10 weeks or 5 half-lives prior to screening (whichever is longer), or have a history of inadequate therapeutic response or intolerance to prior anti-IL-4Rα monoclonal antibody treatment for seasonal allergic rhinitis.
• Subjects with known hypersensitivity to stapokibart, any anti-IL-4Rα monoclonal antibody, or any ingredients of background concomitant medications.
• Subjects who newly initiate allergen-specific immunotherapy within 3 months before screening or intend to receive such therapy during the trial, or whose allergen exposure at home or workplace is expected to change significantly throughout the study period.
• Subjects with poorly controlled recent asthma or concomitant severe asthma with percent predicted Forced Expiratory Volume in one second(FEV1) ≤50% at screening.
• Subjects presenting other active nasal comorbidities at screening (chronic rhinitis, drug-induced rhinitis, chronic rhinosinusitis with or without nasal polyps, severe nasal septal deviation, etc.) that may interfere with efficacy determination.
• Subjects with current or past history of infections of special concern (active tuberculosis, helminthic infections, severe herpes virus infections, etc.), or diagnosed with malignant tumors within 5 years before screening, excluding fully cured cervical carcinoma in situ and non-metastatic cutaneous squamous or basal cell carcinoma.
• Subjects with severe underlying medical conditions including severe hepatic and renal impairment, autoimmune diseases, cardiovascular and cerebrovascular disorders, HIV infection, active hepatitis B/C, immunosuppression, or history of solid organ/hematopoietic stem cell transplantation which, in the investigator's opinion, may pose safety risks via trial participation.
• Have a serious underlying medical condition that, in the opinion of the investigator, may pose a risk to subject safety by participation in a clinical trial.