This study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial aimed at evaluating the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of SHR-1819 injection in patients with Seasonal Allergic Rhinitis (SAR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
196
SHR-1819 injection.
SHR-1819 injection placebo.
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGMean change from baseline in the daily reflective Total Nasal Symptom Score (rTNSS) within 2 weeks of treatment.
Time frame: 2 weeks.
Mean change from baseline in the daily reflective Total Nasal Symptom Score (rTNSS) within 4 weeks of treatment.
Time frame: 4 weeks.
Mean percent change from baseline in the daily reflective Total Ocular Symptom Score (rTOSS) within 2 and 4 weeks of treatment.
Time frame: 2 and 4 weeks.
Mean percent change from baseline in the daily reflective Total Nasal Symptom Score (rTNSS) within 2 and 4 weeks of treatment.
Time frame: 2 and 4 weeks.
Mean change from baseline in the daily AM reflective Total Nasal Symptom Score (AM rTNSS) within 2 and 4 weeks of treatment.
Time frame: 2 and 4 weeks.
Mean change from baseline in the daily PM reflective Total Nasal Symptom Score (PM rTNSS) within 2 and 4 weeks of treatment.
Time frame: 2 and 4 weeks.
Mean change and percent change from baseline in the daily pre-morning dose instantaneous Total Nasal Symptom Score (iTNSS) within 2 and 4 weeks of treatment.
Time frame: 2 and 4 weeks.
Mean change from baseline in the daily/daily AM/daily PM/reflective individual nasal symptom scores (rhinorrhea, nasal congestion, nasal itching, and sneezing) within 2 and 4 weeks of treatment.
Time frame: 2 and 4 weeks.
Mean change from baseline in the daily reflective Total Ocular Symptom Score (rTOSS) within 2 and 4 weeks of treatment.
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Time frame: 2 and 4 weeks.
Change from baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score within 2 and 4 weeks of treatment.
Time frame: 2 and 4 weeks.
Total number of days without nasal symptoms, without nasal congestion symptoms, and without any symptoms from the baseline visit to the end of Week 2 and Week 4 of treatment.
Time frame: 2 and 4 weeks.