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Anti-IL-4Rα monoclonal antibody (CM310) in patients with chronic rhinosinusitis with nasal polyps (CROWNS-2): Rationale and design of a multicenter, randomized, double-blind, placebo-controlled, parallel-group study

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机构: [1]Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. [2]Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Key Laboratory of Otolaryngology Head and Neck Surgery (Ministry of Education of China), Beijing, China. [3]Research Unit of Diagnosis and Treatment of Chronic Nasal Diseases, Chinese Academy of Medical Sciences, Beijing, China. [4]Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, China.
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关键词: Chronic rhinosinusitis with nasal polyps interleukin-4 receptor alpha placebo-controlled randomized

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Chronic rhinosinusitis with nasal polyps (CRSwNP) is a heterogeneous disease that affects a large proportion of the global population. The treatment of CRSwNP, especially eosinophilic CRSwNP (ECRSwNP), has always been of great obstacle. Our previous phase 2 trial showed that CM310, a monoclonal antibody that targets interleukin-4 receptor alpha, was both safe and effective in reducing the size of nasal polyps, improving symptom scores, and increasing the quality of life for those with severe ECRSwNP.This phase 3 trial aims to evaluate the efficacy, safety, pharmacokinetic, pharmacodynamic, and immunogenicity of CM310 in participants with CRSwNP.The CROWNS-2 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 trial. The study consisted of a screening/run-in period (up to 4 weeks), a treatment period (24-week double-blind treatment period plus 28-week maintenance period), and a safety follow-up period (8 weeks). The study planned to enroll 180 participants with CRSwNP (at least 60% of ECRSwNP) to receive CM310 300 mg/placebo every 2 weeks (Q2W) subcutaneously for a total of 12 doses in double-blind treatment period and 300 mg CM310 Q2W subcutaneously for a total of 14 doses in maintenance period. Enrolled participants continued to use mometasone furoate nasal spray throughout the study. The primary endpoints are a change from baseline in nasal polyp score and nasal congestion score at week 24 between CM310 and placebo in both ECRSwNP and CRSwNP.The CROWNS-2 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical study to evaluate the efficacy and safety of CM310 in patients with CRSwNP.NCT05436275.Copyright © 2024. Asia Pacific Association of Allergy, Asthma and Clinical Immunology.

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第一作者机构: [1]Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. [2]Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Key Laboratory of Otolaryngology Head and Neck Surgery (Ministry of Education of China), Beijing, China. [3]Research Unit of Diagnosis and Treatment of Chronic Nasal Diseases, Chinese Academy of Medical Sciences, Beijing, China.
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通讯机构: [1]Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. [2]Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Key Laboratory of Otolaryngology Head and Neck Surgery (Ministry of Education of China), Beijing, China. [3]Research Unit of Diagnosis and Treatment of Chronic Nasal Diseases, Chinese Academy of Medical Sciences, Beijing, China. [4]Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, China. [*1]Departments of Otolaryngology Head and Neck surgery and Allergy, Beijing TongRen Hospital, Capital Medical University, No.1, Dong Jiao Min Xiang, Dongcheng District, Beijing 100730, China.
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