BridgeMD
Omalizumab for monotherapy treatment of patients with food allergies to plant-based foods due to sensitization to LTP and profilin
EU CTIS ID: 2025-524629-42-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Males or females aged 14-55 years who sign the informed consent (IC) for the study and Biobank sample storage.
- 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).
- 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.
- Selection of a group of LTP-allergic individuals with therapeutic failure after treatment with ITSL-Pru p 3.
You likely can't join 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.
See the full eligibility criteria
- Males or females aged 14-55 years who sign the informed consent (IC) for the study and Biobank sample storage.
- 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).
- 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.
- Selection of a group of LTP-allergic individuals with therapeutic failure after treatment with ITSL-Pru p 3.
- 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 for the consumption of the food under investigation, e.g. due to work-related difficulties.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.