2025-524629-42-00招募中2 期
Omalizumab for monotherapy treatment of patients with food allergies to plant-based foods due to sensitization to LTP and profilin
Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2026年3月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Clinical efficacy defined as an increase in the amounts of peach in patients allergic to LTP and melon in patients allergic to apple tolerated in PPO after 16 weeks of treatment with omalizumab.
研究概览
简要总结
To analyse the clinical efficacy of treatment with omalizumab as monotherapy for 16 weeks in patients allergic to vegetables due to sensitisation to LTP and profilin.
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 14-55 years who sign the informed consent (IC) for the study and Biobank sample storage.
- •lant food allergy due to sensitisation to LTP, patients allergic to profilin confirmed by suggestive clinical history, positive skin tests and specific IgE to Pru p 3 (peach LTP) and Pho d 2 (Phoenix dactylifera profilin).
- •Positive oral challenge test (OCT) to peach and at least one other food in patients allergic to LTP and positive oral challenge test to melon and at least one other food in patients allergic to profilin.
- •Selection of a group of LTP-allergic individuals with therapeutic failure after treatment with ITSL-Pru p 3.
排除标准
- •Pregnancy and lactation.
- •Immunological diseases; treatment with immunomodulatory and/or blocking drugs.
- •Mental illness, which makes it impossible to follow and adhere to treatment (e.g. major depression, psychosis, etc.).
- •Severe atopic dermatitis according to SCORAD 5: FEV1<70% (this test will be carried out as a priority in patients with a previous diagnosis of asthma).
- •Inflammation in the oral cavity with severe symptoms, as well as with oral surgery in the previous 7 days.
- •Immunotherapy with pollens in the previous 2 years.
- •Subjects unable to comply with the schedule of visits during the study, as well as for the consumption of the food under investigation, e.g. due to work-related difficulties.
研究组 & 干预措施
Omlyclo 75 mg solution for injection in pre-filled syringe
Test
干预措施: Omlyclo 75 mg solution for injection in pre-filled syringe (Drug)
结局指标
主要结局
Clinical efficacy defined as an increase in the amounts of peach in patients allergic to LTP and melon in patients allergic to apple tolerated in PPO after 16 weeks of treatment with omalizumab.
Clinical efficacy defined as an increase in the amounts of peach in patients allergic to LTP and melon in patients allergic to apple tolerated in PPO after 16 weeks of treatment with omalizumab.
次要结局
- Clinical efficacy defined as an increase in the amounts of at least 1 other food related to sensitisation to LTP (quantitative).
- Clinical efficacy defined as an increase in the amounts of at least 1 more food related to sensitisation to profilin (quantitative).
- Analysis of quality of life before and after treatment with omalizumab.
研究者
Maria Jose Torres
Scientific
Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
研究点 (1)
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