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Clinical Trials in the EU / 2025-524629-42-00
Authorised Phase II

Omalizumab for monotherapy treatment of patients with food allergies to plant-based foods due to sensitization to LTP and profilin

2025-524629-42-00 · tracked via the Priya Life Science EU tracker
Sponsor
Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
Sponsor type
Laboratory/Research/Testing facility
Therapeutic area
Not possible to specify
Decision date
17/04/2026
Enrollment target
37
Sites
Spain

Condition studied

Categoria 2, Patients with vegetable allergies due to sensitization to profilin and LTPs, and those patients in whom sublingual immunotherapy with Pru p 3 (peach LTP) has not been effective, were evaluated in a before-after study to assess changes in clinical reactivity to LTP (peach) and profilin (melon) and immunological changes after intervention with omalizumab.

Investigational medicinal product(s)

Omlyclo 75 mg solution for injection in pre-filled syringe

Eligibility

Age group
18-64 years, 0-17 years
Sex
Female, Male

Primary endpoint

Clinical efficacy defined as an increase in the amounts of peach in patients allergic to LTP and melon in patients allergic to apple tolerated in PPO after 16 weeks of treatment with omalizumab.

Endpoint detail

Clinical efficacy defined as an increase in the amounts of at least 1 other food related to sensitisation to LTP (quantitative)., Clinical efficacy defined as an increase in the amounts of at least 1 more food related to sensitisation to profilin (quantitative)., Analysis of quality of life before and after treatment with omalizumab.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-524629-42-00 on CTIS ↗ ← All trials in the EU