Clinical Trial

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

Study acronym: Omlyclo
Not Yet Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-09.
Trial Details
NCT Number NCT07073404
Lead Sponsor Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Collaborators: Biomedical Research Institute of Málaga
Conditions Food Allergies
Enrollment 37 participants
Start Date 2026-01
Primary Completion 2027-06 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-08-12