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Study on Long-Term Safety of Ligelizumab for Patients with Food Allergies

Fast replyRegistered drugNo placebo
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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 studying the long-term safety and effectiveness of a treatment called ligelizumab for individuals with food allergy. Food allergy is a condition where certain foods trigger an abnormal immune response, leading to symptoms that can range from mild to severe. The study aims to understand how well ligelizumab works over an extended period and how safe it is for patients who have already participated in previous studies involving this treatment.

Participants in this study will receive ligelizumab, which is administered as a solution for injection. The study will also include a comparison with a placebo to evaluate the treatment's effects. Additionally, some participants may receive other medications such as salbutamol, which is used for inhalation, and epinephrine, which is given as an injection. Another treatment being studied is PCM001, which is a granule form for oral suspension made from defatted peanut powder. These treatments are part of the study to assess their role in managing food allergies.

The study will take place over several years, during which participants will attend regular visits to receive their treatments and undergo assessments. These assessments will help researchers gather information on how well the treatments are tolerated and their impact on food allergy symptoms. The goal is to provide valuable insights into the long-term management of food allergies using ligelizumab and other related treatments.

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

    Joining the study

    Upon joining the study, ensure that the informed consent form is signed. If applicable, a legal representative must also sign the assent form. If you reach the age of legal majority during the study, re-consent is required at the next visit.

    Confirm completion of the treatment period in any previous ligelizumab Phase III studies related to food allergy.

  2. Step 2

    Study visits and procedures

    Adhere to scheduled study visits and procedures. This includes receiving injections of the study treatment, ligelizumab, which is administered through subcutaneous use.

    Participate in the open label oral food challenge (OL-OFC) at specified timepoints.

  3. Step 3

    Medication administration

    Receive ligelizumab injections as part of the study treatment. The frequency and dosage will be determined by the study protocol and communicated during visits.

  4. Step 4

    Avoidance of allergens

    Continue to avoid exposure to allergens and any other foods you are allergic to throughout the study, as per the core study guidelines.

  5. Step 5

    Safety and tolerability evaluation

    The main objective of the study is to evaluate the long-term safety and tolerability of ligelizumab in participants with food allergy.

    Monitor for any treatment-emergent adverse events (AEs) and serious adverse events (SAEs) during the study.

  6. Step 6

    Completion of the study

    The study is estimated to end on July 20, 2029. Ensure all study-related activities and visits are completed by this date.

Who can join the trial?

5 criteria

  • Signed informed consent form and assent form (if needed) must be obtained from the participant or their legal representative before joining the study. If a participant is a minor and reaches the age of legal adulthood during the study, they must sign the consent form again at their next study visit.
  • Participants must have completed the treatment period in any previous Phase III studies involving ligelizumab for food allergy. Ligelizumab is a medication being studied for its effects on food allergies.
  • Participants must be willing to attend all study visits and follow the study procedures, which include receiving injections (study treatment) and taking part in the OL-OFC (open label oral food challenge). An open label oral food challenge is a test where participants eat small amounts of a food to see if they have an allergic reaction.
  • Participants must agree to continue avoiding exposure to allergens (substances that cause allergic reactions) and any other foods they are allergic to throughout the study.
  • Participants must be able to safely continue in the study as determined by the study doctor.

Who cannot join the trial?

7 criteria

  • Participants who have a history of severe allergic reactions to the study medication.
  • Participants with any other medical condition that the study doctor believes would make it unsafe for them to participate.
  • Participants who are currently taking other medications that might interfere with the study medication.
  • Participants who are pregnant or breastfeeding.
  • Participants who have participated in another clinical trial within the last 30 days.
  • Participants who have a history of drug or alcohol abuse.
  • Participants who are unable to comply with the study procedures.
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Investigated drugs

Ligelizumab is a medication being studied for its potential to help people with food allergies. It works by targeting a specific part of the immune system that is involved in allergic reactions. The goal of using ligelizumab is to reduce the severity of allergic reactions to certain foods, making it safer for people with food allergies to eat a wider variety of foods without experiencing severe symptoms. This study is focused on understanding how safe ligelizumab is for long-term use and how well it continues to work over time for those who have already participated in earlier studies of the medication.

What is already known about the treatment

Ligelizumab – Ligelizumab is administered as an injection, typically under the skin, and is currently being studied for its long-term safety and effectiveness in treating food allergies. It is in the clinical trial phase, specifically in a multi-year study, to ensure it is safe and works well for patients who have completed earlier studies. The main use of ligelizumab is to help manage food allergies, which can cause severe reactions in some people. At the molecular level, ligelizumab works by blocking a specific protein involved in allergic reactions, helping to reduce symptoms. It is classified as a monoclonal antibody, a type of medication designed to target specific substances in the body.

Investigated diseases

Food allergy – Food allergy is an immune system reaction that occurs soon after eating a certain food. Even a tiny amount of the allergy-causing food can trigger signs and symptoms such as digestive problems, hives, or swollen airways. In some people, a food allergy can cause severe symptoms or even a life-threatening reaction known as anaphylaxis. The progression of food allergies can vary; some individuals may experience worsening symptoms over time, while others may see an improvement or outgrow the allergy. The immune system mistakenly identifies a specific food or a substance in food as something harmful, triggering the release of chemicals like histamine. This response can affect the skin, gastrointestinal tract, respiratory system, and cardiovascular system.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502366-25-00Protocol codeCQGE031G12303BEstimated enrolment550 patientsSponsorNovartis Pharma AG

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).