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NCT Number: NCT07073404

Omalizumab for Plant-Food Allergy Due to Sensitization to LTP or Profilin

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.

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Key information

Conditions

Food Allergies Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

14 year–55 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omalizumab Injection

Drug

Treatment with omalizumab in monotherapy for 16 weeks in patients allergic to vegetables due to sensitization to lipid transfer proteins (LTPs) and profilin.

Other names: Omlyclo

Primary outcomes

  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

    Time frame: 16 weeks

    Clinical efficacy will be assessed by measuring the change in the amount (grams) of peach (in LTP-allergic patients) or melon (in profilin-allergic patients) tolerated during a physician-supervised oral food challenge (PPO) after 16 weeks of omalizumab monotherapy. The oral food challenge will be conducted according to standardized EAACI protocols, and the maximum tolerated dose without objective symptoms will be recorded.

Secondary outcomes

  1. To analyze the changes induced in the immunological profile after the intervention: -Humoral: IgE and IgG4 levels to peach LTP (Pru p 3) and palm tree profilin (Pho d 2) by immunoassays.

    Time frame: 16 weeks

  2. To analyze the changes induced in the immunological profile after the intervention: 2.2-Cellular: activation of peach LTP basophils (Pru p 3) and palm profilin (Pho d 2) by flow cytometry.

    Time frame: 16 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Francisca Gómez Pérez

CONTACT

[email protected]

699972598

María José Torres Jaén, MD, PhD

CONTACT

[email protected]

952131615

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Other

Collaborators

  • Institute of Biomedical Research in Málaga (IBIMA)

Registry information

Official study title

Omalizumab for the Monotherapy Treatment of Patients With Allergy to Foods of Plant Origin Due to Sensitization to Lipid Transfer Proteins (LTPs) and Profilin

Acronym: Omlyclo

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 18, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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