This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial. Its primary objective is to explore and preliminarily evaluate the efficacy and safety of LP-003 Injection in the treatment of participants with chronic rhinosinusitis with nasal polyps (CRSwNP), as well as to investigate its pharmacokinetic (PK), pharmacodynamic (PD) profiles, and immunogenicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
s.c. injection, Q12W
s.c. injection, Q12W
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, China
Change from baseline in Nasal Polyps Score (NPS) at Week 24
NPS is a bilateral endoscopic assessment scale for nasal polyposis, where each nasal cavity is scored from 0 to 4. The total score is the sum of the left and right sides, ranging from 0 to 8, with higher scores indicating more severe nasal polyp disease.
Time frame: Week 24
Change from baseline in Nasal Congestion Score (NCS) at Week 24
The NCS is a patient-reported outcome measure using a 0-3 point Verbal Rating Scale (VRS). Patients rate their nasal congestion severity as 0 (no symptoms), 1 (mild symptoms), 2 (moderate symptoms), or 3 (severe symptoms). The total score ranges from 0 to 3, with higher scores indicating more severe nasal congestion.
Time frame: Week 24
Change from baseline in NPS at each assessment visit (excluding Week 24)
Time frame: Up to approximately 56 weeks
Percentage of participants with a ≥1-point improvement in NPS from baseline
Time frame: Up to approximately 56 weeks
Percentage of participants with a ≥2-point improvement in NPS from baseline
Time frame: Up to approximately 56 weeks
Change from baseline in NCS at each assessment visit (excluding Week 24)
Time frame: Up to approximately 56 weeks
Percentage of participants with a ≥1-point improvement in NCS from baseline
Time frame: Up to approximately 56 weeks
Change from baseline in Total Score of 22-Items Sinonasal Outcome Test (SNOT-22)
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The SNOT-22 is a validated 22-items questionnaire to assess the impact of chronic rhinosinusitis on health-related quality of life (HRQoL) with a recall period of 2 weeks. There are 5 domains that could be described within SNOT-22, including nasal, ear, sleep, general and practical, and emotional; each domain was scored on a 6-category scale which ranged from 0: no problem to 5: problem as bad as it can be. The total score was the sum of response to each of the 22 questions and ranged from 0 (no disease) to 110 (worst disease), higher scores indicated worse HRQoL.
Time frame: Up to approximately 56 weeks
Incidence of adverse events (AEs)
Time frame: Up to approximately 56 weeks
Number of patients with anti-drug antibodies (ADA)
Time frame: Up to approximately 56 weeks
Serum concentrations of LP-003
Time frame: Up to approximately 56 weeks