Oral Immunotherapy for Peanut Allergic Patients

Launched by INNOUP FARMA S.L. · Nov 12, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called INP20, which is an oral immunotherapy aimed at helping people who are allergic to peanuts. The goal is to see if this treatment is safe, how well it works, and to find the right dose for patients. The study has two parts: the first part involves giving different doses of INP20 to participants aged 12 to 65 over two weeks, while the second part lasts six months and compares the effects of INP20 with a placebo (a treatment that looks like the real thing but has no active ingredients) to see how well it helps reduce peanut allergy symptoms.

To be eligible for this trial, participants must have a confirmed peanut allergy, which can be shown by a skin test or blood test, and must have experienced serious allergic reactions after eating peanuts in the past. Participants will need to have access to an emergency epinephrine injector and must be willing to follow specific guidelines throughout the study. If you or a family member might be interested in participating, you will receive INP20 or a placebo daily for six months, and the researchers will closely monitor your health and reactions during this time.

Gender

ALL

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.