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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Navarra Pamplona Spain

Other Sites

No sites found in this category

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

Trial status

Country Status Recruitment Start
Spain Spain
Not yet recruiting
17.12.2019

Trial locations

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.

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 ID:
2024-518501-17-00
Protocol code:
INP20-01
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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