Oral immunotherapy for patients with peanut allergies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, double-blind, randomized, placebo-controlled phase I/II study aims to evaluate the safety, tolerability, and potential efficacy of INP20, an oral immunotherapy for individuals with peanut allergies. The study consists of two parts: Part A involves a dose escalation with six different oral doses administered daily for two weeks to patients aged 12 to 65 who have a history of allergic reactions to peanuts. Part B is a six-month phase where participants are randomized into three groups to receive either INP20 or a placebo, allowing for a thorough assessment of the treatment's effectiveness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The presence of specific IgE to peanuts (a positive skin prick test to peanuts (diameter of wheal \> 3.0 mm) and a positive peanut IgEs \[CAP-FEIA\] \> 0.35 kUA/L.
* A history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts.
* Have a positive double-blind placebo-controlled food challenge (DBPCFC) to peanut at a cumulative dose of less than 10 grams of peanut protein.
* Provide signed informed consent for the participation in the study.
* Have self-injectable epinephrine available at home and be trained on its proper use.
* Potentially fertile women must agree to be sexually inactive or to use appropriate contraceptive measures for the duration of the study and for 1 month afterward.

Exclusion Criteria:

* History of severe anaphylaxis to peanut as defined by respiratory distress with cyanosis, hypoxemia (O2 Sat \<92%) or, in the absence of other clinical records, severe dyspnea; hypotension with or without loss of consciousness; or relaxation of sphincters.
* Currently participating in another study using an investigational new drug.
* Participation in any interventional study, specific oral or sublingual immunotherapy building up phase for the treatment of food allergy in the past 12 months.
* Allergic to placebo ingredients or reacts to any dose of placebo during study entry DBPCFC.
* Patients allergic to corn food.
* Poor control or persistent activation of severe atopic dermatitis.
* Moderate to severe persistent asthma.
* Prior intubation/mechanical ventilation for asthma.
* Currently being treated with greater than medium daily doses of inhaled corticosteroids (fluticasone \>500 μg per day, ciclesonide \>400 μg per day or budesonide \>800 μg per day) or montelukast.
* Chronic gastrointestinal diseases.
* Primary or secondary immunodeficiency.
* Have a severe reaction at initial DBPCFC (life-threatening anaphylaxis or reaction requiring hospitalization).
* Chronic use of beta blockers, angiotensin converting enzyme inhibitors, or monoamine oxidase inhibitors, proton pump inhibitors, H2-bloquers, prokinetic drugs and laxatives.
* Inability to discontinue antihistamines for 7 days before skin testing and oral food challenges (OFCs).
* Patients diagnosed with other serious food allergies defined as those who have required intubation and/or ICU admission.
* Women of childbearing potential (unless they are using highly effective methods of contraception during dosing and for at least 1 month after stopping medication), who are pregnant, planning to become pregnant, or breastfeeding.
* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study may also exclude a participant from the study.

Where it's running

• Clinica Universidad de Navarra
  Pamplona, Navarre, Spain Recruiting
• Complejo Hospittalario de Navarra
  Pamplona, Navarre, Spain Recruiting

Study contacts

• Principal investigator: Marta Ferrer, PhD, MD — Clinica Universidad de Navarra
• Study coordinator: Maite Agüeros, PhD
• Email: magueros@innoupfarma.com
• Phone: +34 639151974

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remibrutinib for IgE-mediated peanut, milk, and egg allergy

  This study tests whether remibrutinib can help people with peanut, milk, or egg allergies by comparing it to placebo over 52 weeks.

  Recruiting at 22 sites Phase 3 Novartis · Birmingham, Alabama and 21 other locations · NCT07768371

• UKK-0018 immunotherapy for peanut allergy

  This trial will test whether injections of UKK-0018 can retrain the immune system to reduce allergic reactions in adults with peanut allergy.

  Recruiting at 5 sites Phase 1/2 Ukko Inc · Camperdown, New South Wales and 5 other locations · NCT07349212

• ENP-501 for people with and without peanut allergy

  This trial will test whether ENP-501 is safe and how it affects people aged 14–50 who either have a confirmed peanut allergy or regularly eat peanuts without problems.

  Recruiting Phase 1/2 N-Fold, LLC · Aurora, Colorado · NCT07117669

• Tezepelumab with Peanut OIT for Peanut Allergy

  This study tests whether adding tezepelumab to peanut oral immunotherapy can help people with peanut allergy build lasting tolerance.

  Recruiting at 6 sites Phase 2 National Institute of Allergy and Infectious Diseases (NIAID) · Little Rock, Arkansas and 9 other locations · NCT07015996

• Investigating new methods for oral immunotherapy in food allergies

  This study is testing new ways to use oral immunotherapy to help people with food allergies, like those to peanuts and milk, feel safer and have fewer allergic reactions during treatment.

  Recruiting McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec · NCT06256146

• Oral Microbiota Transplantation for Peanut Allergy Treatment

  This study is testing if a new treatment using gut bacteria can help teenagers with peanut allergies tolerate peanuts better.

  Recruiting Phase 2 Boston Children's Hospital · Boston, Massachusetts · NCT05695261

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.