This is a multi-center, randomized, double blind, placebo-controlled Phase III study to evaluate the efficacy and safety of CM326, and to observe the Pharmacokinetics, Pharmacodynamics and I immumogenicity\[c2.1\] of CM326 in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).The study consists of four periods, including an up to 4-week screening/run-in period, a 24-week double-blind randomized treatment period, a 28-week open-label treatment period, and an 8-week safety follow-up period.
Understand the study and voluntarily sign the informed consent form.
Age between 18 and 75 years (inclusive) at the time of informed consent signing, regardless of gender.
Diagnosis of bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) meeting the diagnostic criteria of the "Chinese Guidelines for the Diagnosis and Treatment of Chronic Rhinosinusitis (2024)".
Meet at least 1 of the following 4 items: a. Received SCS treatment for at least 3 consecutive days within 2 years prior to screening; b. Received at least one long-acting SCS (such as triamcinolone acetonide injection) within 2 years prior to screening; c. Had [c8.1]contraindications to SCS treatment or intolerance to SCS treatment; d. Received nasal polyp surgery more than 6 months prior to screening.
Presence of nasal conditions affecting NPS evaluation, including but not limited to: a. Antrochoanal polyps; b. Nasal septum perforation or severe nasal septum deviation occluding at least one nostril; c. Nasal surgery that alters the structure of the lateral nasal wall precluding completion of the NPS assessment.
Clinically significant comorbidities other than asthma that may affect the efficacy assessment or interfere with the interpretation of the efficacy assessment results, including but not limited to: a. Allergic granulomatosis with polyangiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), allergic bronchopulmonary mycosis, and eosinophilic esophagitis; b. Bronchiectasis, pulmonary fibrosis, cystic fibrosis; c. Primary ciliary dyskinesia, Young's syndrome, Kartagner's syndrome, or other ciliary dyskinesia syndromes; d. Acute sinusitis, nasal infection, or upper respiratory tract infection at the time of the screening visit or within 2 weeks prior to the screening visit; e. Persistent rhinitis medicamentosa; f. Imaging suspected or confirmed fungal sinusitis; g. Malignant or benign tumors of the nasal cavity or paranasal sinuses.
Uncontrolled epistaxis within 2 months prior to screening;
Concomitant major chronic diseases that are uncontrolled and that, in the opinion of the investigator, may increase the safety risk of the participant's participation in this study;
Parallel
CM326 injection
Biological/VaccineCM326 injection, administered subcutaneously, once every 4 weeks
Placebo of CM326
DrugPlacebo of CM326, administered subcutaneously, once every 4 weeks
Change from baseline in Nasal Polyp Score(NPS) at week 24
Change from baseline in Nasal Polyp Score(NPS) at week 24. The NPS will be assessed through centralized image review by a third-party institution.
Change of Nasal Congestion Score(NCS) at week 24
Change of Nasal Congestion Score(NCS) at week 24. The NCS will be collected via patient-reported electronic diary.
Change from baseline in Nasal Polyp Score(NPS) at each predefined time point
Change from baseline in Nasal Polyp Score(NPS) at each predefined time point. The NPS will be assessed through centralized image review by a third-party institution.
Change of Nasal Congestion Score(NCS) at each predefined time point.
Change from baseline in Nasal Congestion Score(NCS) at each predefined time point.The NCS will be collected via patient-reported electronic diary.
Proportions of participants with an improvement of ≥1 point and ≥2 points in NPS
Proportions of participants with an improvement of ≥1 point and ≥2 points in NPS compared to the baseline at Week 24 and Week 52
Proportions of participants with the NPS of no more than 1 point in each nasal cavity
Proportions of participants with NPS of no more than 1 point in each nasal cavity at Week 24 and Week 52
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