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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Not possible to specify

Decision date (initial)

2026-04-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To analyse the clinical efficacy of treatment with omalizumab as monotherapy for 16
weeks in patients allergic to vegetables due to sensitisation to LTP and profilin.

Secondary objectives 2

1. To analyse clinical changes related to food tolerance as determined by skin test reactivity and tolerance analysis with controlled administration of at least 2 foods to which the patient has a demonstrated reaction with controlled oral food challenge (PPOCA), before and after treatment.
2. To analyse the changes induced in the immunological profile after the intervention: 2.1- Humoral: levels of IgE and IgG4 to peach LTP (Pru p 3) and palm profilin (Pho d 2) by immunoassays. 2.2- Cell: activation of peach LTP basophils (Pru p 3) and palm tree profilin (Pho d 2) by flow cytometry.

Conditions and MedDRA coding

Categoria 2

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Males or females aged 14-55 years who sign the informed consent (IC) for the study and Biobank sample storage.
2. lant food allergy due to sensitisation to LTP, patients allergic to profilin confirmed by suggestive clinical history, positive skin tests and specific IgE to Pru p 3 (peach LTP) and Pho d 2 (Phoenix dactylifera profilin).
3. Positive oral challenge test (OCT) 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.
4. Selection of a group of LTP-allergic individuals with therapeutic failure after treatment with ITSL-Pru p 3.

Exclusion criteria 7

1. Pregnancy and lactation.
2. Immunological diseases; treatment with immunomodulatory and/or blocking drugs.
3. Mental illness, which makes it impossible to follow and adhere to treatment (e.g. major depression, psychosis, etc.).
4. 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).
5. Inflammation in the oral cavity with severe symptoms, as well as with oral surgery in the previous 7 days.
6. Immunotherapy with pollens in the previous 2 years.
7. Subjects unable to comply with the schedule of visits during the study, as well as for the consumption of the food under investigation, e.g. due to work-related difficulties.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 3

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud

Sponsor organisation

Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud

Address

Calle De Severo Ochoa 35, Parque Tecnologico De Andalucia Parque Tecnologico De Andalucia

City

Malaga

Postcode

29590

Country

Spain

Scientific contact point

Organisation

Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud

Contact name

Maria Jose Torres

Public contact point

Organisation

Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud

Contact name

Maria Jose Torres

Sponsor responsibilities

Article 77 compliance

Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud

Contact point sponsor

Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud

Article 77 implementation

Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications