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Study on the Safety and Effectiveness of Low-Dose Oral Immunotherapy with Omalizumab for Children with Severe Cow's Milk Allergy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on children with a severe allergy to cow's milk, specifically an IgE-mediated cow's milk allergy. The study is investigating the use of a treatment called Omalizumab, which is a medication given as an injection. Omalizumab is known to help manage allergies by targeting a specific protein in the body that plays a role in allergic reactions. The study will also involve a process called oral immunotherapy, where small amounts of milk are gradually introduced to the child's diet to help build tolerance.

The purpose of the study is to analyze the safety and effectiveness of combining low-dose oral immunotherapy with Omalizumab in children with severe cow's milk allergy. During the study, participants will receive injections of Omalizumab and will be exposed to small amounts of milk under medical supervision. The study will monitor how well the children tolerate the milk and whether the treatment helps reduce allergic reactions over time.

The study will last for a period of up to 18 months. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and to assess the effectiveness of the treatment. The goal is to see if the combination of Omalizumab and oral immunotherapy can help children with severe cow's milk allergy tolerate milk better and experience fewer allergic reactions.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history related to cow's milk allergy and conducting tests such as skin tests for cow's milk and casein.

    Participants must have a documented history of severe allergic reactions to cow's milk and meet specific criteria, including age and weight requirements.

  2. Step 2

    Omalizumab treatment initiation

    Participants begin treatment with omalizumab, a medication administered through subcutaneous injection. The specific dosage and frequency are determined by the study protocol.

    Omalizumab is used to help manage severe allergic reactions and is given in a solution form via a pre-filled syringe.

  3. Step 3

    Oral immunotherapy introduction

    After starting omalizumab, participants begin low-dose oral immunotherapy with cow's milk. This involves gradually introducing small amounts of milk protein to build tolerance.

    The goal is to safely increase the amount of milk protein that can be tolerated without severe allergic reactions.

  4. Step 4

    Monitoring and adjustments

    Throughout the study, participants are closely monitored for any allergic reactions or side effects. Adjustments to the treatment plan may be made based on individual responses.

    Regular check-ups and assessments are conducted to ensure safety and efficacy of the treatment.

  5. Step 5

    Oral challenge tests

    Participants undergo oral challenge tests to evaluate their tolerance to cow's milk protein. These tests are conducted in a controlled environment to ensure safety.

    The primary goal is to determine the proportion of participants who can tolerate 300 mg of cow's milk protein without severe symptoms.

  6. Step 6

    Completion and evaluation

    At the end of the study, a final evaluation is conducted to assess the overall effectiveness and safety of the combined treatment.

    Participants' ability to tolerate cow's milk protein is measured, and the results contribute to understanding the potential benefits of this treatment approach.

Who can join the trial?

8 criteria

  • Men and women between the ages of 6 and 15 at the time of signing the consent or assent.
  • Signature of informed consent and/or assent, which must be obtained before participating in the study. Parents or legal guardians and participants aged 12-15 must be able to understand and provide written consent and assent, respectively.
  • Documented medical history of an allergy to milk or foods containing milk.
  • Episodes of anaphylaxis due to ingestion of cow's milk and/or a diagnosis of asthma. Anaphylaxis is a severe allergic reaction that can be life-threatening. Asthma is a condition where the airways in the lungs become narrow and swollen, making it hard to breathe.
  • Serum IgE to cow's milk and casein greater than 49 kUA/L at Screening Visit 1. IgE is a type of antibody that the body makes in response to an allergy.
  • Positive skin tests for cow's milk and casein. This means the skin reacts with a wheal diameter greater than 3 mm compared to the negative control. A wheal is a raised, itchy area of skin.
  • Participants must weigh more than 19 kg at Screening Visit 1.
  • Participants must be able to receive injections (study drug), perform oral challenge testing, and must continue to be exposed to cow's milk throughout the study.

Who cannot join the trial?

6 criteria

  • Patients who do not have a severe IgE-mediated cow's milk allergy cannot participate. This means if your allergy to cow's milk is not severe or is not related to IgE, you are not eligible. IgE is a type of antibody that plays a role in allergies.
  • Patients who are not within the specified age range cannot participate. The trial is for a specific age group, so if you are outside this range, you are not eligible.
  • Patients who are not willing to follow the trial procedures cannot participate. This means you must be ready to follow the instructions and procedures of the study.
  • Patients who have other health conditions that might interfere with the study cannot participate. If you have other medical issues that could affect the trial, you are not eligible.
  • Patients who are pregnant or planning to become pregnant during the study cannot participate. This is to ensure the safety of both the mother and the baby.
  • Patients who are currently participating in another clinical trial cannot participate. Being in another study might affect the results of this trial.
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Investigated drugs

  • Omalizumab

    is a medication used in this study to help manage severe cow's milk allergy in children. It works by blocking a substance in the body that can cause allergic reactions. In this trial, the dose of Omalizumab is reduced to see if it can still effectively help with the allergy when used together with another treatment.

  • Oral Immunotherapy with Low Doses of Milk

    is a treatment approach used in this study to help children with severe cow's milk allergy. It involves giving small, gradually increasing amounts of milk to the child to help their body become less sensitive to it. This therapy is combined with Omalizumab to see if it can improve the safety and effectiveness of the treatment.

What is already known about the treatment

Omalizumab – This medication is administered as an injection under the skin and is currently being studied for its effectiveness in treating severe IgE-mediated cow's milk allergy. It is well-documented in medical literature as a treatment for various allergic conditions. The main therapeutic indication for Omalizumab in this study is to help manage severe cow's milk allergy in children. At the molecular level, Omalizumab works by binding to immunoglobulin E (IgE), a molecule involved in allergic reactions, thereby preventing it from attaching to cells that trigger allergy symptoms. It is classified pharmacologically as a monoclonal antibody.

Investigated diseases

Severe IgE-mediated cow's milk allergy – This is an allergic reaction that occurs when the immune system mistakenly identifies proteins in cow's milk as harmful. It involves the production of Immunoglobulin E (IgE) antibodies, which trigger the release of chemicals like histamine, leading to symptoms. These symptoms can range from mild, such as hives or stomach upset, to severe, including difficulty breathing or anaphylaxis. The progression of the allergy can vary, with some individuals experiencing more severe reactions over time. It is often diagnosed in infancy or early childhood, and while some children outgrow it, others may continue to have the allergy into adulthood. Avoidance of cow's milk and products containing it is typically necessary to prevent allergic reactions.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IITrial ID2023-503958-12-00Estimated enrolment20 patientsSponsorHospital Infantil Universitario Nino Jesus

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).