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A Study to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Characteristics of LP-003 Injection in Participants With Wheat Allergy

2026年9月7日 更新者：Longbio Pharma (Suzhou) Co., Ltd.

A Multicenter, Randomized, Open-Label Phase II Clinical Trial to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Characteristics of LP-003 Injection in Participants With Wheat Allergy

This is a multicenter, randomized, open-label Phase II clinical study to evaluate the safety, efficacy, pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity profiles of LP-003 injection in participants with Wheat dependent exercise induced anaphylaxis. Its primary objective is to explore and preliminarily evaluate the efficacy of LP-003 Injection in the participants with Wheat dependent exercise induced anaphylaxis, as well as to investigate its safety, pharmacokinetic (PK), pharmacodynamic (PD) profiles, and immunogenicity.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

12

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国
        • Peking Union Medical College Hospital
        • 首席研究员：
          • Kai Guan
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Aged ≥12 years and ≤60 years, male or female;
  • History of wheat or gluten allergy;
  • Positive skin prick test (SPT) to the allergen (wheat or gluten), and/or positive allergen-specific immunoglobulin E (sIgE) to food allergen (crude wheat/gluten extract or ω 5 gliadin) at screening or within three months prior to screening;
  • Dose-limiting symptoms occurred at a cumulative dose of ≤24 g gluten protein during the food-exercise challenge test at screening;
  • No plan to conceive and agree to use effective contraceptive measures throughout the trial period;
  • The participant and/or parent/legal representative understands and voluntarily signs the informed consent form.

Exclusion Criteria:

  • Allergic to LP-003 Injection or its excipients;
  • Uncontrolled asthma or severe asthma at screening;
  • Any severe disease;
  • History of severe allergic reactions to wheat or gluten;
  • Not enough washing-out period for previous therapy before the food exercise challenge at screening.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：LP-003 Dose 1
Participants will receive subcutaneous injection of LP-003 Injection at Dose 1.
生物：LP-003 Injection
s.c. injection, Q8W
实验性的：LP-003 Dose 2
Participants will receive subcutaneous injection of LP-003 Injection at Dose 2.
生物：LP-003 Injection
s.c. injection, Q8W

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Proportion of participants who consumed a cumulative dose of 24 g gluten protein without dose limiting symptoms in the food exercise challenge test.
大体时间：Week 24
Week 24

次要结果测量

结果测量
措施说明
大体时间
Maximum tolerated cumulative dose of gluten protein (the highest dose without dose-limiting symptoms) in the food exercise challenge test
大体时间：Week 24
Week 24
Proportion of participants who used any rescue medication (e.g., albuterol, epinephrine, or others) within 24 weeks
大体时间：Week 24
Week 24
Change from baseline in the age-specific Food Allergy Quality of Life Questionnaire (FAQLQ).
大体时间：Week 24
The Food Allergy Quality of Life Questionnaires (FAQLQ) are disease-specific health-related quality of life (HRQL) questionnaires for patients with food allergy. FAQLQ-Teenager Form consists of 23 items and FAQLQ-Adult Form consists of 29 items. The raw score for each item ranges from 0 to 6, which is recorded as 1 to 7. Higher scores indicate greater impairment of food allergy-related quality of life.
Week 24
Change from baseline in the age-specific Food Allergy Independent Measure (FAIM).
大体时间：Week 24
The FAIM (Food Allergy Independent Measure) consists of 7 items and each item is rated from 0 to 6, and a higher total score reflects a higher perceived risk or probability of experiencing an adverse event. The FAIM can therefore be seen as a patient-reported measure of perceived severity.
Week 24
Incidence of Treatment-Emergent Adverse Events (TEAEs) .
大体时间：Up to approximately 36 weeks
Incidence and severity of TEAEs from first dose to end of study are recorded.
Up to approximately 36 weeks
Serum concentrations of LP-003
大体时间：Up to approximately 36 weeks
Up to approximately 36 weeks
Concentrations of free immunoglobulin E (IgE) and total IgE
大体时间：Up to approximately 36 weeks
Up to approximately 36 weeks
Anti-drug antibodies (ADA), and neutralizing antibodies (Nab)
大体时间：Up to approximately 36 weeks
Up to approximately 36 weeks

其他结果措施

结果测量
大体时间
Change from baseline in individual cut-off values of Basophil Activation Test (BAT).
大体时间：Week 24
Week 24
Change from baseline in the positive sensitization rate of allergen-specific IgE (sIgE)
大体时间：Week 24
Week 24

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Longbio Pharma (Suzhou) Co., Ltd.

调查人员

  • 首席研究员：Kai Guan、Peking Union Medical College Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月4日

初级完成 (估计的)

2027年7月16日

研究完成 (估计的)

2027年10月15日

研究注册日期

首次提交

2026年9月7日

首先提交符合 QC 标准的

2026年9月7日

首次发布 (实际的)

2026年9月11日

研究记录更新

最后更新发布 (实际的)

2026年9月11日

上次提交的符合 QC 标准的更新

2026年9月7日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • P10-LP003-06

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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