Omalizumab for Plant-Food Allergy Due to Sensitization to LTP or Profilin (NCT07073404) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Omalizumab for Plant-Food Allergy Due to Sensitization to LTP or Profilin
37 participantsStarted 2026-01
Plain-language summary
Omalizumab has demonstrated efficacy, increasing the tolerance threshold in patients with multiple food allergies, as well as reducing the risk of severe reactions when used as monotherapy. This favors improving the reactivity profile of patients with food allergy. In our setting, plant allergy caused by sensitization to panallergens such as lipid transfer proteins (LTPs) and profilins entails important limitations for the consumption of a healthy diet due to the extensive dietary restrictions.
The main objective of this project is to analyze the efficacy of treatment with omalizumab administered every 2-4/weeks, used in monotherapy in patients with plant allergy due to sensitization to profilin and LTPs and those patients in whom sublingual immunotherapy with Pru p 3 (peach LTP), has not been effective, by performing a before-after study we will evaluate the changes in clinical reactivity to LTP (peach) and profilin (melon) and the changes immunological effect after omalizumab intervention. In addition, we will evaluate the changes in reactivity to at least one food other than peach and melon in the different sensitization profiles.
Who can participate
Age range
14 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males or females aged 14-55 years who sign the informed consent (IC) for the study and Biobank sample storage.
* Allergy to plant foods due to sensitisation to LTP, patients allergic to profilin confirmed by a 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 (OPT) 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.
Exclusion Criteria:
* 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 due to the consumption of the food under investigation, for example, due to work difficulties.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in tolerated dose of peach or melon during physician-supervised oral food challenge (PPO) in patients with vegetable allergy due to sensitization to lipid transfer proteins (LTPs) or profilin
Timeframe: 16 weeks
Trial details
NCT IDNCT07073404
SponsorFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud