This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of LP-003 injection in patients with moderate to severe seasonal allergic rhinitis inadequately controlled by standard-of-care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
546
Beijing Shijitan Hospital, Capital Medical University (the formerly Beijing Railway General Hospital)
Beijing, China
Mean daily reflective total nasal symptom score (rTNSS) during the pollen peak period (PPP)
The rTNSS is a patient self-reported questionnaire of four nasal symptoms: nasal itching, nasal congestion, sneezing and rhinorrhea. Patients will report their symptoms reflected or felt over the last 12 hours. Each symptom is scored on a 0-3 scale (0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe). The total score is the sum of the four items, ranging from 0 to 12, with higher scores indicating greater symptom severity.
Time frame: Up to 4 Months
Mean daily rTNSS during the pollen period (PP)
Time frame: Up to 4 Months
Mean daily instantaneous total nasal symptom score (iTNSS) during the PPP
Time frame: Up to 4 Months
Mean daily iTNSS during the PP
Time frame: Up to 4 Months
Mean daily rTNSS combined with rescue medication score (DNSMS) during the PPP
Integrates daily rTNSS (4 nasal symptoms, 0-3 each, total 0-12) and rescue medication score (0 for no rescue use and 1 for rescue use).
Time frame: Up to 4 Months
Mean daily total ocular symptom score (TOSS) during the PPP
It is derived from 2 individual ocular symptoms (itching/burning/redness, and tearing/watering), and each symptom is scored on a 0-3 scale. The daily TOSS is the sum of the two items, ranging from 0 (no symptoms) to 6 (maximum severity) per day.
Time frame: Up to 4 Months
Mean daily TOSS combined with rescue medication score (DNOMS) during the PPP
Integrates daily TOSS (2 individual ocular symptoms, 0-3 each, total 0-6) and rescue medication score (0 for no rescue use and 1 for rescue use).
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Time frame: Up to 4 Months
Mean daily rescue medication score (RMS) during the PPP
The RSM is assessed based on the usage of montelukast sodium tablets, with a scoring rule of 0 points for no use and 1 point for use on the day. The mean daily RSM during the PPP is calculated as the sum of the cumulative RSM during the PPP divided by the number of days in the PPP.
Time frame: Up to 4 Months
Incidence of adverse events (AEs)
Time frame: Up to Week 28