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.

IF 1.6 Q3 ALLERGY
Asia Pacific Allergy Pub Date : 2024-08-01 Epub Date: 2024-08-05 DOI:10.5415/apallergy.0000000000000156
Shen Shen, Bing Yan, Ming Wang, Di Wu, Chengshuo Wang, Luo Zhang
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引用次数: 0

Abstract

Background: 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.

Objective: This phase 3 trial aims to evaluate the efficacy, safety, pharmacokinetic, pharmacodynamic, and immunogenicity of CM310 in participants with CRSwNP.

Result: 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.

Conclusion: 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.

Trial registration: NCT05436275.

抗IL-4Rα单克隆抗体(CM310)治疗伴有鼻息肉的慢性鼻炎患者(CROWNS-2):多中心、随机、双盲、安慰剂对照、平行组研究的原理与设计。
背景:慢性鼻炎伴鼻息肉(CRSwNP)是一种异质性疾病,影响着全球大部分人口。慢性鼻炎伴鼻息肉(CRSwNP),尤其是嗜酸性鼻炎伴鼻息肉(ECRSwNP)的治疗一直是一大障碍。我们之前的 2 期试验表明,CM310(一种靶向白细胞介素-4 受体α的单克隆抗体)在缩小鼻息肉大小、改善症状评分和提高重度 ECRSwNP 患者的生活质量方面既安全又有效:这项3期试验旨在评估CM310对CRSwNP患者的疗效、安全性、药代动力学、药效学和免疫原性:CROWNS-2是一项多中心、随机、双盲、安慰剂对照、平行组的3期试验。研究包括筛选/磨合期(长达 4 周)、治疗期(24 周双盲治疗期加 28 周维持期)和安全随访期(8 周)。该研究计划招募180名CRSwNP患者(至少60%为ECRSwNP),在双盲治疗期每2周(Q2W)皮下注射300毫克CM310/安慰剂,共12次;在维持治疗期每2周皮下注射300毫克CM310,共14次。入选者在整个研究期间继续使用糠酸莫米松鼻喷雾剂。主要终点是在第24周时,CM310与安慰剂在ECRSwNP和CRSwNP中的鼻息肉评分和鼻塞评分与基线相比的变化:CROWNS-2是一项多中心、随机、双盲、安慰剂对照、平行组的3期临床研究,旨在评估CM310对CRSwNP患者的疗效和安全性:试验注册:NCT05436275。
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来源期刊
CiteScore
2.50
自引率
5.90%
发文量
33
期刊介绍: Asia Pacific Allergy (AP Allergy) is the official journal of the Asia Pacific Association of Allergy, Asthma and Clinical Immunology (APAAACI). Although the primary aim of the journal is to promote communication between Asia Pacific scientists who are interested in allergy, asthma, and clinical immunology including immunodeficiency, the journal is intended to be available worldwide. To enable scientists and clinicians from emerging societies appreciate the scope and intent of the journal, early issues will contain more educational review material. For better communication and understanding, it will include rational concepts related to the diagnosis and management of asthma and other immunological conditions. Over time, the journal will increase the number of original research papers to become the foremost citation journal for allergy and clinical immunology information of the Asia Pacific in the future.
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