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Rademikibart Treatment for Moderate-to-Severe Uncontrolled Asthma A Phase 2B Randomized Clinical Trial 期刊论文

编号：

4569B9F827D9C202365B8179DC63D0C7
作者：

Kerwin, Edward#^[1]Yang, Ting(杨汀)^[2]Su, Nan(苏楠)^[2]Guo, Jiawang^[3];Adivikolanu, Radha^[4];Longphre, Malinda^[4];Wang, Junying^[2];Yun, Jili^[3];Pan, Wuban^[3];Wei, Zheng^[4];Collazo, Raul*^[4]
语种：

英文
期刊：

AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE ISSN：1073-449X 2025 年 211 卷 5 期 (749 - 758) ; MAY 1
Associated data：

ClinicalTrials.gov/NCT04773678
收录：
关键词：

rademikibart IL-4Ra asthma Type 2 lung function
摘要：

Rationale: Rademikibart (formerly CBP-201) is an IL-4R alpha-targeting antibody. Objectives: We sought to evaluate rademikibart in adults with moderate-to-severe, persistent, uncontrolled asthma. Methods: In this global Phase 2b trial, 322 patients were randomized 1:1:1 to two rademikibart groups (150 mg or 300 mg every other week, after a 600-mg loading dose) or a placebo group; rademikibart or placebo was administered subcutaneously for 24 weeks. Measurements and Main Results: Prebronchodilator (trough) forced expiratory volume in 1 second (FEV1) at Week 12 (primary endpoint) improved with rademikibart at 150 mg and 300 mg: Least squares mean changes (95% confidence interval), above placebo, were 140 ml (44-236 ml; P = 0.005) and 189 ml (92-286 ml; P < 0.001), respectively. Prebronchodilator (trough) FEV1 improvements occurred rapidly during Week 1, were sustained through Week 24, and were greatest in patients with high baseline blood eosinophils (patients with >= 300 eosinophils/ml experienced placebo-adjusted FEV1 improvement at Week 24 of 420 ml [95% confidence interval = 239-600 ml] in the 300-mg group). Rapid and sustained statistically significant improvements were also observed in percent predicted FEV1 and Asthma Control Questionnaire score across 24 weeks. Through Week 24, proportions of patients with one or more exacerbations were 7.5% (150 mg) and 9.3% (300 mg) versus 16.7% (placebo). Eighty-eight percent of patients completed treatment. Treatment-emergent adverse events were generally similar to placebo, and no eosinophilia was observed. Injection site reactions were mostly mild. The most common treatment-emergent adverse events (10-12% of patients) were cough, coronavirus disease (COVID-19), and dyspnea. Conclusions: Rapid and sustained improvements in lung function and asthma control were gained across 24 weeks of rademikibart therapy. Clinical trial registered with www.clinicaltrials.gov (NCT 04773678).
推荐引用方式
GB/T 7714：

Kerwin Edward,Yang Ting,Su Nan, et al. Rademikibart Treatment for Moderate-to-Severe Uncontrolled Asthma A Phase 2B Randomized Clinical Trial [J].AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE,2025,211(5):749-758.
APA：

Kerwin Edward,Yang Ting,Su Nan,Guo Jiawang,&Collazo Raul.(2025).Rademikibart Treatment for Moderate-to-Severe Uncontrolled Asthma A Phase 2B Randomized Clinical Trial .AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE,211(5):749-758.
MLA：

Kerwin Edward, et al. "Rademikibart Treatment for Moderate-to-Severe Uncontrolled Asthma A Phase 2B Randomized Clinical Trial" .AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE 211,5(2025):749-758.
入库时间：

2025/4/1 21:09:52
更新时间：

2025/5/28 8:14:53
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