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

Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study ID
NCT07073404
Status
Not Yet Recruiting

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Conditions

  • Food Allergies

Eligibility Criteria

Sex
ALL
Age
14 Years - 55 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jan 31, 2026
Status verified
Aug 2025
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
37 participants (estimated)

Primary Outcome Measure

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 ]

Central Contacts