A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis

• GR1802 injection (Biological): Recombinant fully human anti-IL4Rα monoclonal antibody drug.
• Placebo (Biological): Placebo

Primary outcomes

• Change from Baseline in rTNSS( reflective total nasal symptom scores) [up to 2 weeks]: Scores range from 0 to 12, with higher scores indicating more severe symptoms.

Secondary outcomes

• Change from Baseline in rTOSS( reflective total ocular symptom scores) [up to 2、4 weeks]: Scores range from 0 to 9, with higher scores indicating more severe symptoms.
• Change from Baseline in rTNSS [up to 4 weeks]: Scores range from 0 to 12, with higher scores indicating more severe symptoms.
• Mean change from baseline in iTNSS(instantaneous total nasal symptom scores) [week 2、4]: Scores range from 0 to 12, with higher scores indicating more severe symptoms.
• Mean change from baseline in iTOSS(instantaneous total ocular symptom scores) [week 2、4]: Scores range from 0 to 9, with higher scores indicating more severe symptoms.
• Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores [week2、4]: There are 28 questions in 7 fields，Each question is answered on a 7-point scale (0 to 6).
• Adverse events (AEs) [up to 12 weeks]
• Incidence of ADAs [up to 12 weeks]
• Ctrough [up to 12 weeks]

Sex: All, ages: 18 Years to 75 Years

Main Inclusion Criteria:

1. Voluntarily sign the informed consent form.
2. Seasonal allergic rhinitis has been prevalent for at least 2 years.
3. Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past.
4. Positive serum-specific IgE test results.
5. Symptom severity scores for the season met the enrollment criteria.

Main Exclusion Criteria:

1. Other nasal comorbidities or co-morbidities/states that may be present at the time of screening that affect efficacy determination.
2. Subjects whose allergen exposures in their home or work environments may be expected to change significantly during the trial period.
3. Subjects with poorly controlled recent asthma conditions.
4. Presence of current or past history of infection of special concern, e.g., active tuberculosis, helminthic infections, severe herpes virus infections, etc.
5. Previous use of anti-interleukin 4 receptor alpha subunit (IL4Rα) monoclonal antibody.
6. 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.