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

NCT07073404 | Not Yet Recruiting

• 1 other identifier: Omalizumab proyect
• Study Type: observational
• Target: 37
• Locations: 0 countries
• Sites: N/A

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

Keywords

Omalizumab; FOOD ALLERGIES; LTP; Profilins; Allergy desensitization; Lipid transfer proteins

Outcome Measures

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

  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.

  16 weeks

Secondary Outcomes (2)

• 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.

  16 weeks

• 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.

  16 weeks

Interventions

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.

Also known as: Omlyclo

Eligibility Criteria

• Age: 14 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with allergy to plant foods due to sensitisation to LTP and profilin

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead
• Institute of Biomedical Research in Málaga (IBIMA): collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples will be collected at baseline (T0), 2 months (T2), and 4-5 months (T4) after initiation of omalizumab treatment. A total of 60 mL of peripheral blood will be obtained per timepoint: 10 mL in serum separator tubes for humoral studies, 10 mL in lithium heparin tubes for basophil activation test (BAT), and the remaining volume processed using Ficoll gradient for isolation and cryopreservation of peripheral blood mononuclear cells (PBMCs) in liquid nitrogen for future cellular and genomic analyses. Immunological assays include measurement of total and specific IgE and IgG4 to Pru p 3 and Pho d 2 (via ImmunoCAP), and basophil activation test (BAT) analyzed by flow cytometry. Samples may be used for further omics or genetic studies.

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• María José Torres Jaén, MD, PhD

  Hospital Regional de Malaga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

María José Torres Jaén, MD, PhD

CONTACT

952131615; mjtorresj@uma.es

Francisca Gómez Pérez

CONTACT

699972598; francisca.gomez.p.sspa@juntadeanadalucia.es

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08