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.
Capable of understanding the study and voluntarily signing the Informed Consent Form (ICF);
Aged 18 to 75 years (inclusive) at the time of signing the ICF, regardless of gender;
Diagnosis of bilateral chronic rhinosinusitis with nasal polyps (CRSwNP);
Nasal congestion;
Concurrent other nasal diseases or nasal symptoms;
Acute upper respiratory tract infection at screening, which the investigator assesses may affect nasal symptom scoring;
Severe infection requiring intravenous antibiotics and/or hospitalization within 4 weeks prior to randomization that has not yet resolved, or active infection requiring oral antibiotics within 2 weeks prior to randomization that has not yet resolved; the investigator assesses that enrollment of the participant may pose uncontrollable risks;
Concurrent active parasitic infection (e.g., helminths) or suspected parasitic infection;
Parallel
LP-003 Injection
Biological/Vaccines.c. injection, Q12W
Placebo of LP-003
Biological/Vaccines.c. injection, Q12W
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.
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.
Change from baseline in NPS at each assessment visit (excluding Week 24)
Percentage of participants with a ≥1-point improvement in NPS from baseline
Percentage of participants with a ≥2-point improvement in NPS from baseline
Change from baseline in NCS at each assessment visit (excluding Week 24)
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