Oral immunotherapy for patients with peanut allergies

A Multicenter Double-blind, Randomized, Placebocontrolled Phase I/II Study to Determine the Safety, Tolerability, Potential Efficacy and Dose Finding of INP20, an Oral Formulation for Treatment of Immunotherapy in Peanut-allergic Patients

This study is testing a new oral treatment for people with peanut allergies to see if it can help them tolerate peanuts better and stay safe from allergic reactions.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 12 Years to 65 Years
• Sex: All
• Sponsor: InnoUp Farma S.L. (Industry-sponsored)
• Drugs / interventions: immunotherapy
• Locations: 2 sites (Pamplona, Navarre and 1 other locations)
• Trial ID: NCT04163562 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 12 to 65 with a confirmed peanut allergy and a history of immediate hypersensitive reactions to peanuts.

Not a fit: Patients with a history of severe anaphylaxis to peanuts may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce allergic reactions to peanuts in affected patients.

How similar studies have performed: Other studies on oral immunotherapy for food allergies have shown promising results, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Pamplona, Navarre and 1 other locations

• 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

Conditions Peanut Allergy