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

NCT ID: NCT07073404

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-12-31

Brief 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.

Conditions

Food Allergies

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Omalizumab Injection

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

Intervention Type: DRUG

Other Intervention Names

Omlyclo

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Biomedical Research in Málaga (IBIMA)

UNKNOWN

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

María José Torres Jaén, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Regional de Malaga

Central Contacts

María José Torres Jaén, MD, PhD

Role: CONTACT

mjtorresj@uma.es

952131615

Francisca Gómez Pérez

Role: CONTACT

francisca.gomez.p.sspa@juntadeanadalucia.es

699972598

Other Identifiers

Omalizumab proyect

Identifier Type: -

Identifier Source: org_study_id