Food AllergiesOmlycloNCT07073404
Omalizumab for Plant-Food Allergy Due to Sensitization to LTP or Profilin
An observational study of Food Allergies, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 55 years
- Conditions the study is for
- Food Allergies
- What is being tested?
- Omalizumab Injection
- Type of treatment
- Injection or infusion
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with allergy to plant foods due to sensitisation to LTP and profilin
Who may be able to join
- Males or females aged 14-55 years who sign the informed consent (IC) for the study and Biobank sample storage.
- Allergy to plant foods due to sensitisation to LTP, patients allergic to profilin confirmed by a 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 (OPT) 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.
Who cannot join
- 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 due to the consumption of the food under investigation, for example, due to work difficulties.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Omalizumab for the Monotherapy Treatment of Patients With Allergy to Foods of Plant Origin Due to Sensitization to Lipid Transfer Proteins (LTPs) and Profilin
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.
- Conditions
- Food Allergies
- Being tested
- Omalizumab Injection
- Keywords
- Omalizumab, FOOD ALLERGIES, LTP, Profilins, Allergy desensitization, Lipid transfer proteins
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omalizumab InjectionDrug
Also called Omlyclo
Treatment with omalizumab in monotherapy for 16 weeks in patients allergic to vegetables due to sensitization to lipid transfer proteins (LTPs) and profilin.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Clinical efficacy will be assessed by measuring the change in the amount (grams) of peach (in LTP-allergic patients) or melon (in profilin-allergic patients) tolerated during a physician-supervised oral food challenge (PPO) after 16 weeks of omalizumab monotherapy. The oral food challenge will be conducted according to standardized EAACI protocols, and the maximum tolerated dose without objective symptoms will be recorded.
Measured: 16 weeks
Secondary outcomes (2)
To analyze the changes induced in the immunological profile after the intervention: -Humoral: IgE and IgG4 levels to peach LTP (Pru p 3) and palm tree profilin (Pho d 2) by immunoassays.
Measured: 16 weeks
To analyze the changes induced in the immunological profile after the intervention: 2.2-Cellular: activation of peach LTP basophils (Pru p 3) and palm profilin (Pho d 2) by flow cytometry.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study startJan 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Biomedical Research Institute of Málaga
- Responsible party
- Sponsor
- Investigators
- María José Torres Jaén, MD, PhD, Principal investigator, Hospital Regional de Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073404
- Sponsor's protocol ID
- Omalizumab proyect
- Acronym
- Omlyclo
- Status last verified
- Aug 2025
- First submitted
- 9 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omalizumab for the Monotherapy Treatment of Patients With Allergy to Foods of Plant Origin Due to Sensitization to Lipid Transfer Proteins (LTPs) and Profilin
- ClinicalTrials.gov ID
- NCT07073404
- Acronym / sponsor ID
- Omlyclo / Omalizumab proyect
- Conditions
- Food Allergies
- Keywords
- Omalizumab, FOOD ALLERGIES, LTP, Profilins, Allergy desensitization, Lipid transfer proteins
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Collaborators
- Biomedical Research Institute of Málaga
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with allergy to plant foods due to sensitisation to LTP and profilin
Key inclusion criteria (4 listed)
- Males or females aged 14-55 years who sign the informed consent (IC) for the study and Biobank sample storage.
- Allergy to plant foods due to sensitisation to LTP, patients allergic to profilin confirmed by a 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 (OPT) 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omalizumab InjectionAlso: OmlycloTreatment with omalizumab in monotherapy for 16 weeks in patients allergic to vegetables due to sensitization to lipid transfer proteins (LTPs) and profilin. | Drug | – |
Primary outcome
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
Clinical efficacy will be assessed by measuring the change in the amount (grams) of peach (in LTP-allergic patients) or melon (in profilin-allergic patients) tolerated during a physician-supervised oral food challenge (PPO) after 16 weeks of omalizumab monotherapy. The oral food challenge will be conducted according to standardized EAACI protocols, and the maximum tolerated dose without objective symptoms will be recorded.
2 secondary outcomes
To analyze the changes induced in the immunological profile after the intervention: -Humoral: IgE and IgG4 levels to peach LTP (Pru p 3) and palm tree profilin (Pho d 2) by immunoassays.
Time frame: 16 weeks
To analyze the changes induced in the immunological profile after the intervention: 2.2-Cellular: activation of peach LTP basophils (Pru p 3) and palm profilin (Pho d 2) by flow cytometry.
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
María José Torres Jaén, MD, PhD principal investigator
Hospital Regional de Malaga
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergies, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María José Torres Jaén, MD, PhD (952131615, mjtorresj@uma.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.