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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Clinico San Carlos Madrid Spain
Centre Hospitalier Universitaire De Lille Lille France
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Azienda Ospedaliera di Padova Padua Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Medaimun GmbH Frankfurt Germany
Les Hopitaux Universitaires De Strasbourg STRASBOURG, Alsace France
Centre Hospitalier Universitaire De Toulouse Toulouse France
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Charite Research Organisation GmbH Berlin Germany
Deutsches Herzzentrum Berlin Berlin Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Chta Dp Njikh Vandoeuvre Les Nancy France
Gdwdok Uhmsjajmar Fjkvgmlgi Frankfurt Germany
Cfsmzs Hbxybhwgbfh Rrpxolqv Dtjmtdikyoutkn Angers France
Hxwioweb Vnja dqoqdfeq Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
01.08.2023
Germany Germany
Not recruiting
01.08.2023
Italy Italy
Not recruiting
01.08.2023
Spain Spain
Not recruiting
01.08.2023
The Netherlands The Netherlands
Not recruiting
01.08.2023

Trial locations

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.

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 ID:
2022-502366-25-00
Protocol code:
CQGE031G12303B
Trial Phase:
Therapeutic confirmatory (Phase III)

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