Guan Kai, Liu Shuang, Feng Yan, Li Lisha, Zhu Xiaoming, Bill Nai-Chau-Sun, Ma Haili, Yang Jie, Han Cuicui, Liu Heng, Wei Qingyu, Shi Haiyun, Wang Xueyan
Department of Allergy, Beijing Key Laboratory of Precision Medicine for Diagnosis and Treatment on Allergic Diseases, National Clinical Research Center for Dermatologic and Immunologic Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Department of Otorhinolaryngology Head and Neck Surgery, Shanxi Key Laboratory of Otorhinolaryngology Head and Neck Cancer, The First Hospital, Shanxi Medical University, Taiyuan, Shanxi, China.
Clin Transl Allergy. 2025 Jun;15(6):e70074. doi: 10.1002/clt2.70074.
Anti-IgE therapy can serve as an option for inadequately controlled seasonal allergic rhinitis (SAR) patients. LP-003, a novel anti-IgE antibody, is being tested as an add-on treatment for SAR. This trial aimed to evaluate whether LP-003 is effective and safe for SAR.
This placebo-controlled double-blind phase 2 randomized clinical trial was conducted in 17 hospitals in China. SAR patients whose symptoms were inadequately controlled despite first-line treatment (nasal corticosteroids with or without oral antihistamine) in the previous two seasons were enrolled between July 6, 2023 and August 7, 2023. Participants were randomized in a ratio of 2:4:3 to receive subcutaneous injections of 100 mg LP-003, 200 mg LP-003 or placebo every 4 weeks for 2 doses. All patients received fluticasone propionate as standard-of-care (SoC). The main outcome was the mean total nasal symptom score (TNSS) during the peak pollen period (PPP). Secondary endpoints included a series of symptom and medication scores, quality of life assessments during PPP and pollen period (PP), immunogenicity and safety.
A total of 180 participants were randomly assigned. The LP-003 + SoC treatment achieved a significantly lower TNSS compared with placebo + SoC (3.31 vs. 4.06, intergroup difference = -0.74, p = 0.0464). For key secondary outcomes, the LP-003 group also achieved significantly lower daily nasal symptom and rescue medication use scores (3.54 vs. 4.42, intergroup difference = -0.88, p = 0.0352), and daily ocular symptom and rescue medication use scores (1.66 vs. 2.19, intergroup difference = -0.54, p = 0.0245) compared to the placebo group. The suppression of free IgE was prevalent and persistent. There was no statistically significant difference in adverse events and severe adverse events between LP-003 and placebo groups.
These findings support LP-003 as a promising add-on option to the SoC for patients with moderate to severe SAR. Fixed dosage regimen and extensive suppression of free-IgE render it a cutting-edge advantage.
抗IgE疗法可作为季节性过敏性鼻炎（SAR）控制不佳患者的一种选择。新型抗IgE抗体LP - 003正在作为SAR的附加治疗进行测试。本试验旨在评估LP - 003对SAR是否有效且安全。
这项安慰剂对照的双盲2期随机临床试验在中国的17家医院进行。纳入在过去两个季节一线治疗（鼻用糖皮质激素联合或不联合口服抗组胺药）后症状仍控制不佳的SAR患者，入组时间为2023年7月6日至2023年8月7日。参与者按2:4:3的比例随机分组，每4周皮下注射100mg LP - 003、200mg LP - 003或安慰剂，共注射2剂。所有患者均接受丙酸氟替卡松作为标准治疗（SoC）。主要结局是花粉高峰期（PPP）的平均总鼻症状评分（TNSS）。次要终点包括一系列症状和用药评分、PPP和花粉期（PP）的生活质量评估、免疫原性和安全性。
共随机分配了180名参与者。与安慰剂 + SoC相比，LP - 003 + SoC治疗的TNSS显著更低（3.31对4.06，组间差异 = -0.74，p = 0.0464）。对于关键次要结局，与安慰剂组相比，LP - 003组的每日鼻症状和急救药物使用评分也显著更低（3.54对4.42，组间差异 = -0.88，p = 0.0352），以及每日眼部症状和急救药物使用评分（1.66对2.19，组间差异 = -0.54，p = 0.0245）。游离IgE的抑制普遍且持续。LP - 003组和安慰剂组在不良事件和严重不良事件方面无统计学显著差异。
这些发现支持LP - 003作为中重度SAR患者SoC的一种有前景的附加治疗选择。固定剂量方案和对游离IgE的广泛抑制使其具有前沿优势。
