Ongoing Clinical Trials for Food Allergy
Currently, there are 5 ongoing clinical trials investigating new treatments for food allergies. These studies focus primarily on peanut allergy and cow’s milk allergy, testing different approaches including skin patches, oral immunotherapy, and injectable medications. Trials are being conducted across several European countries, offering opportunities for children and adolescents to access experimental treatments under careful medical supervision.
Clinical trial locations
- France
- Germany
- Ireland
- Italy
- Netherlands
- Spain
- Study on the Safety and Effectiveness of Low-Dose Oral Immunotherapy with Omalizumab for Children with Severe Cow’s Milk Allergy
- Study on the Safety and Tolerability of INP20 for Peanut Allergy in Patients
- Study on Long-Term Safety of Ligelizumab for Patients with Food Allergies
- Study on the Effectiveness and Safety of DBV712 for Peanut Allergy in Children Aged 4-7
Study on the Safety and Effectiveness of Low-Dose Oral Immunotherapy with Omalizumab for Children with Severe Cow’s Milk Allergy
This trial is investigating a combination treatment approach for children with severe cow’s milk allergy in Spain. The study examines whether using Omalizumab, an injectable medication, together with gradually introducing small amounts of milk, can help children build tolerance to dairy products.
Main inclusion criteria: Children aged 6 to 15 years who have a documented history of severe allergic reactions to cow’s milk or foods containing milk, including episodes of anaphylaxis or asthma diagnosis. Participants must have high levels of specific antibodies to cow’s milk and casein, positive skin tests, and weigh more than 19 kg. They must be willing to receive injections and continue exposure to cow’s milk throughout the study.
Main exclusion criteria: The study excludes patients who do not have a severe IgE-mediated cow’s milk allergy, those outside the specified age range, participants unwilling to follow trial procedures, those with other health conditions that might interfere with the study, pregnant individuals or those planning pregnancy, and anyone currently participating in another clinical trial.
Study focus: The trial aims to analyze the safety and effectiveness of combining low-dose oral immunotherapy with Omalizumab over an 18-month period. Participants receive Omalizumab injections while being exposed to gradually increasing amounts of milk under medical supervision. The study monitors how well children tolerate milk and whether the treatment reduces allergic reactions over time.
Investigational drug: Omalizumab is a monoclonal antibody that works by blocking immunoglobulin E, a molecule involved in allergic reactions. In this study, it is used at reduced doses in combination with oral immunotherapy involving small, gradually increasing amounts of milk.
Study on the Safety and Tolerability of INP20 for Peanut Allergy in Patients
This Spanish trial is testing INP20, an oral medication made from peanut extract nanoparticles, designed to help people with peanut allergies. The study is divided into two parts: the first determines the safest and most effective dose, while the second evaluates the treatment over six months.
Main inclusion criteria: Participants must be at least 12 years old with a confirmed peanut allergy, demonstrated by positive skin tests and blood tests showing peanut-specific IgE levels above 0.35 kUA/L. They must have a history of significant allergic symptoms after eating peanuts or have avoided peanuts due to unknown tolerance. Participants need to have self-injectable epinephrine available and know how to use it. Women of childbearing age must agree to use effective birth control during the study.
Main exclusion criteria: The study excludes individuals without a peanut allergy, children younger than 4 years old, those outside the specified age range, and individuals who are part of a vulnerable population requiring special protection or care.
Study focus: The trial aims to determine the maximum tolerated dose and recommended dose of INP20, an oral immunotherapy agent. It evaluates safety and tolerability through regular monitoring of allergic reactions and side effects. The study includes oral challenge tests to measure participants’ tolerance to peanut protein and assess changes in immune response markers such as IgE and IgG4 antibodies.
Investigational drug: INP20 is an oral medication in pill form designed to gradually desensitize the immune system to peanut proteins through repeated exposure to small amounts of peanut extract nanoparticles. It falls under the category of immunotherapy agents.
Study on Long-term Benefits and Safety of DBV712 for Children with Peanut Allergy
This trial, conducted in the Netherlands and Germany, examines the long-term effects of Viaskin Peanut, a skin patch treatment for children with peanut allergy. The study is a follow-up for children who completed a previous trial called EPITOPE.
Main inclusion criteria: Children aged 2 years and older who have a peanut allergy and completed the EPITOPE study, including a specific test at the 12-month mark. Both the child and their parent or guardian must be willing to follow all study rules and requirements. The parent or guardian must sign an informed consent form.
Main exclusion criteria: The study excludes children without a peanut allergy, those not between ages 2 and 17, children with other serious health conditions that might interfere with the study, those taking medications that might affect study results, participants in other recent similar studies, children with a history of severe non-peanut allergic reactions, those with skin conditions that might affect treatment, and children unable to follow study instructions.
Study focus: The trial evaluates the sustained clinical benefit and safety of Viaskin Peanut for up to three years. The patch, containing 250 micrograms of peanut protein, is applied to the skin daily. Regular monitoring includes food challenges to assess changes in peanut protein tolerance and safety assessments to monitor for adverse events and reactions at the patch site.
Investigational drug: Viaskin Peanut is a cutaneous patch used in epicutaneous immunotherapy. It delivers small amounts of peanut protein through the skin to gradually build tolerance and reduce allergic reactions over time.
Study on Long-Term Safety of Ligelizumab for Patients with Food Allergies
This multi-country trial across Spain, Germany, Italy, Netherlands, and France is investigating the long-term safety of ligelizumab for individuals with various food allergies. The study is designed for participants who have already completed previous Phase III studies involving this treatment.
Main inclusion criteria: Participants must have completed the treatment period in any previous Phase III ligelizumab studies for food allergy. They must sign an informed consent form, or if a minor, have their legal representative sign, with re-consent required if they reach legal majority during the study. Participants must be willing to attend all study visits, follow procedures including receiving injections and participating in open label oral food challenges, and continue avoiding exposure to allergens throughout the study.
Main exclusion criteria: The study excludes participants with a history of severe allergic reactions to the study medication, any medical condition deemed unsafe by the study doctor, those taking interfering medications, pregnant or breastfeeding individuals, participants in another trial within the last 30 days, those with a history of drug or alcohol abuse, and anyone unable to comply with study procedures.
Study focus: The primary objective is to evaluate the long-term safety and tolerability of ligelizumab over several years. Participants receive subcutaneous injections at regular intervals and undergo scheduled assessments including open label oral food challenges. The study monitors treatment-emergent adverse events and serious adverse events throughout the extended treatment period.
Investigational drug: Ligelizumab is a monoclonal antibody administered as a subcutaneous injection. It works by blocking a specific protein involved in allergic reactions, helping to reduce symptoms. The medication is designed to help manage various food allergies by targeting the immune system’s response to food allergens.
Study on the Effectiveness and Safety of DBV712 for Peanut Allergy in Children Aged 4-7
This trial is being conducted in Spain, Germany, Netherlands, France, and Ireland, testing Viaskin Peanut (DBV712) in young children aged 4 to 7 years with peanut allergy. The treatment involves a small patch placed on the skin to help reduce sensitivity to peanuts over time.
Main inclusion criteria: Children aged 4 through 7 years with a doctor-diagnosed peanut allergy or well-documented history of allergic reactions to peanuts. Participants must currently follow a strict peanut-free diet and have access to emergency medications including self-injectable epinephrine with a current food allergy emergency action plan. Documentation must show peanut-specific IgE levels greater than 0.7 kUA/L and positive skin prick test with a wheal size of 6 mm or more within the past 6 months. The child must react to 100 mg or less of peanut protein during screening food challenge tests.
Main exclusion criteria: The study has extensive exclusion criteria including children without peanut allergy, those outside the 4-7 age range, and children with various serious health conditions affecting the immune system, skin, breathing, heart, digestive system, nervous system, blood, kidneys, liver, growth, development, or mental health. Also excluded are children with conditions affecting their ability to understand instructions, communicate, eat, move, see, hear, sleep, breathe, learn, play, socialize, participate in activities, attend school, or those who recently participated in other trials or had severe allergic reactions requiring emergency treatment.
Study focus: The 12-month study compares the DBV712 250 microgram patch to a placebo. The patch is applied daily to the skin, and children are monitored through regular monthly check-ups including physical examinations and discussions about side effects. The study assesses effectiveness through food challenges to determine the level of desensitization achieved and monitors for any adverse reactions.
Investigational drug: DBV712, also known as Viaskin Peanut, is a skin patch used in epicutaneous immunotherapy. It gradually exposes the immune system to small amounts of peanut protein through the skin, aiming to build tolerance over time and reduce the risk of severe allergic reactions.
Summary
The five ongoing clinical trials for food allergies demonstrate a clear focus on two main allergens: peanuts and cow’s milk. Peanut allergy is the subject of four of the five studies, highlighting the significant medical need in this area. The trials employ different therapeutic approaches, including skin patches (Viaskin Peanut/DBV712), injectable medications (Omalizumab and Ligelizumab), and oral immunotherapy agents (INP20).
Geographically, Spain and Germany are the most active locations, each hosting four trials, followed by the Netherlands and France with three trials each. This concentration of research in Western European countries suggests strong regional expertise and infrastructure for food allergy clinical research. The studies primarily target pediatric populations, with most trials focusing on children and adolescents, reflecting the high prevalence of food allergies in younger age groups.
The Viaskin Peanut patch (DBV712) is being tested in three separate trials, examining both short-term effectiveness in newly enrolled children and long-term safety in those who completed previous studies. This represents a comprehensive research program for this epicutaneous immunotherapy approach. Meanwhile, the ligelizumab study stands out as the only multi-country, long-term safety evaluation covering various food allergies, not limited to a single allergen.
These trials offer opportunities for families affected by severe food allergies to access experimental treatments under careful medical supervision, while contributing valuable data to advance understanding and management of these potentially life-threatening conditions.
