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Study on the Safety and Tolerability of INP20 for Peanut Allergy in Patients

Verified siteRegistered 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 a condition known as peanut allergy. The trial is testing a new treatment called INP20, which is an oral formulation made from peanut extract nanoparticles. The purpose of the study is to determine the safety, tolerability, and potential effectiveness of INP20 in people who are allergic to peanuts. The study will also help find the best dose of INP20 for treating peanut allergies.

The study is divided into two parts. In the first part, participants will receive different doses of INP20 to find the most suitable dose that is safe and well-tolerated. This part will help identify the maximum dose that can be given without causing significant side effects. In the second part, participants will receive the recommended dose of INP20 for a period of six months to further evaluate its safety and tolerability. Throughout the study, some participants will receive a placebo to compare the effects of INP20 against no active treatment.

Participants in the study will be monitored for any allergic reactions or side effects. The study will also measure changes in the immune response to peanuts, including levels of specific antibodies like IgE and IgG4, which are proteins in the blood that play a role in allergic reactions. The goal is to see if INP20 can help increase the amount of peanut protein that participants can consume without experiencing an allergic reaction. This study aims to provide valuable information on a potential new treatment for managing peanut allergies.

The research process

The trial runs in 5 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, eligibility is confirmed based on specific criteria such as age, presence of peanut allergy, and a history of allergic reactions to peanuts.

    Informed consent is required, and for participants aged 12-17, consent must also be provided by a parent or legal representative.

  2. Step 2

    Part A: dose-ranging study

    This phase involves determining the maximum tolerated dose (MTD) and the recommended dose of INP20, an oral medication for peanut allergy.

    Participants receive increasing doses of INP20 to assess safety and tolerability.

    Regular monitoring includes checking for adverse events, allergic symptoms, and conducting physical examinations and laboratory tests.

  3. Step 3

    Transition to part B

    Participants who complete Part A and meet specific criteria, such as recovery of baseline levels of certain immune markers, may transition to Part B.

  4. Step 4

    Part B: parallel group extension study

    This phase evaluates the safety and tolerability of INP20 at the recommended dose over a 6-month period.

    Participants are divided into groups, with some receiving INP20 and others receiving a placebo.

    Monitoring continues with a focus on allergic reactions, physical health, and laboratory tests.

  5. Step 5

    Completion of the study

    After 6 months, the study concludes with a final assessment of the participant's response to the treatment.

    The study aims to measure changes in the ability to tolerate peanut protein and other immune responses.

Who can join the trial?

8 criteria

  • Be at least 12 years old, regardless of gender, race, or ethnicity.
  • Have a positive test for peanut allergy, which includes a skin test showing a reaction larger than 3.0 mm and a blood test showing peanut-specific IgE levels greater than 0.35 kUA/L. IgE is a type of antibody that indicates an allergic reaction.
  • Have a history of significant allergic symptoms like hives, swelling, runny nose, itching, sneezing, stomach pain, vomiting, diarrhea, wheezing, difficulty breathing, swelling of lips or tongue, throat itching or swelling, or a feeling of panic after eating peanuts, or have avoided peanuts due to unknown tolerance.
  • Have a positive result in a test called DBPCFC (Double-Blind Placebo-Controlled Food Challenge) to peanuts, with a reaction to less than 8.5565 grams of peanut protein.
  • Provide signed informed consent to participate in the study. For those aged 12-17, both the participant and their parent or legal representative must sign.
  • Have self-injectable epinephrine (a medication used to treat severe allergic reactions) available at home and know how to use it properly.
  • Women who can become pregnant must agree to either not engage in sexual activity or use effective birth control during the study and for one month after it ends.
  • If continuing from part A to part B of the study, must have returned to their normal levels of IgG4, another type of antibody.

Who cannot join the trial?

4 criteria

  • Individuals who do not have a peanut allergy cannot participate.
  • Children younger than 4 years old cannot participate.
  • Individuals who are not within the specified age range for the study cannot participate.
  • Individuals who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

INP20 is an oral medication being studied for its potential to help people with peanut allergies. The trial aims to find a safe and effective dose of INP20 that can be taken repeatedly over time. The study is designed to assess how well patients tolerate the medication and to determine the best dose to use in future studies.

What is already known about the treatment

INP20 – INP20 is an oral medication currently being studied in clinical trials for its potential use in treating peanut allergies. It is administered in pill form and is designed to be taken by mouth. The medication is in the early stages of research, specifically in Phase I/II trials, where its safety, tolerability, and optimal dosing are being evaluated. INP20 is intended to help individuals with peanut allergies by gradually desensitizing their immune system to peanut proteins, potentially reducing allergic reactions. It falls under the pharmacological classification of immunotherapy agents, which work by modulating the immune response to allergens.

Investigated diseases

Peanut Allergy – Peanut allergy is a common food allergy that occurs when the immune system mistakenly identifies proteins in peanuts as harmful. Upon exposure, even to small amounts, the body releases chemicals like histamine, leading to allergic reactions. Symptoms can range from mild, such as hives or itching, 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 important for those with peanut allergies to avoid peanuts and be aware of potential cross-contamination in foods. The condition is often diagnosed in childhood, but it can persist into adulthood.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-518501-17-00Protocol codeINP20-01Estimated enrolment84 patientsSponsorInnoup Farma S.L.

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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).