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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Recombinant fully human anti-IL4Rα monoclonal antibody drug.
Placebo
Zhongnan Hospital of Wuhan university
Wuhan, Hubei, China
RECRUITINGChange from Baseline in rTNSS( reflective total nasal symptom scores)
Scores range from 0 to 12, with higher scores indicating more severe symptoms.
Time frame: up to 2 weeks
Change from Baseline in rTOSS( reflective total ocular symptom scores)
Scores range from 0 to 9, with higher scores indicating more severe symptoms.
Time frame: up to 2、4 weeks
Change from Baseline in rTNSS
Scores range from 0 to 12, with higher scores indicating more severe symptoms.
Time frame: up to 4 weeks
Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)
Scores range from 0 to 12, with higher scores indicating more severe symptoms.
Time frame: week 2、4
Mean change from baseline in iTOSS(instantaneous total ocular symptom scores)
Scores range from 0 to 9, with higher scores indicating more severe symptoms.
Time frame: week 2、4
Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores
There are 28 questions in 7 fields,Each question is answered on a 7-point scale (0 to 6).
Time frame: week2、4
Adverse events (AEs)
Time frame: up to 12 weeks
Incidence of ADAs
Time frame: up to 12 weeks
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Time frame: up to 12 weeks