About this trial
Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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≥30kg.
Disqualifiers
Other nasal comorbidities or co-morbidities/states that may be present at the time of screening that affect efficacy determination.
Subjects whose allergen exposures in their home or work environments may be expected to change significantly during the trial period.
Subjects with poorly controlled recent asthma conditions.
Presence of current or past history of infection of special concern, e.g., active tuberculosis, helminthic infections, severe herpes virus infections, etc.
Trial design
Parallel
Treatments tested in this trial
GR1802 injection
Biological/VaccineRecombinant fully human anti-IL4Rα monoclonal antibody drug.
Placebo
Biological/VaccinePlacebo
Treatment groups
Trial outcomes
Primary outcomes
Adverse events (AEs)(Part One)
Change from Baseline in rTNSS( reflective total nasal symptom scores)(Part Two)
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)(Part One/Two)
Scores range from 0 to 9, with higher scores indicating more severe symptoms.
Percentage Change from Baseline in rTNSS(Part One/Two)
Scores range from 0 to 12, with higher scores indicating more severe symptoms.
Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)(Part One/Two)
Scores range from 0 to 12, with higher scores indicating more severe symptoms.
Mean change from baseline in iTOSS(instantaneous total ocular symptom scores)(Part One/Two)
Scores range from 0 to 9, with higher scores indicating more severe symptoms.
Sponsors and contacts
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