Actively Recruiting
Oral Immunotherapy for Peanut Allergic Patients
Led by InnoUp Farma S.L. · Updated on 2025-04-30
50
Participants Needed
2
Research Sites
285 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Multicenter, double-blind, randomized, placebo-controlled phase I/II study to determine the safety, tolerability, potential efficacy and dose finding of INP20, an oral immunotherapy in peanut-allergic patients. The overall study design consists of two sequential periods of Part A and Part B. Part A is a dose escalation study in patients from 12 to 65 years old with a history of immediate hypersensitive reaction to peanut protein. Six diferent oral-dose of INP20 will be administered to 6 cohorts of patients once daily for 2 weeks. Part B is a 6-month double-blind, placebo-controlled, randomized and parallel groups study. Patients will be randomized in a 1:1:1 ratio into three (3) different treatment groups, including placebo and the two doses of peanut protein selected from Part A. They will recieve INP20 once daily for 6 months.
CONDITIONS
Official Title
Oral Immunotherapy for Peanut Allergic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of specific IgE to peanuts demonstrated by a positive skin prick test (wheal > 3.0 mm) and positive peanut IgE blood test (> 0.35 kUA/L)
- History of significant allergic symptoms occurring within 60 minutes after eating peanuts
- Positive double-blind, placebo-controlled food challenge to peanut at a cumulative dose less than 10 grams of peanut protein
- Signed informed consent for participation
- Availability of self-injectable epinephrine at home and training on its use
- Potentially fertile women agree to be sexually inactive or use effective contraception during the study and for 1 month after
You will not qualify if you...
- History of severe anaphylaxis to peanut with respiratory distress, low oxygen saturation, severe breathing difficulty, hypotension, loss of consciousness, or sphincter relaxation
- Participation in another investigational drug study
- Participation in oral or sublingual immunotherapy for food allergy in the past 12 months
- Allergy to placebo ingredients or reaction to placebo during initial food challenge
- Allergy to corn food
- Poorly controlled or active severe atopic dermatitis
- Moderate to severe persistent asthma
- Past intubation or mechanical ventilation for asthma
- Current treatment with high doses of inhaled corticosteroids or montelukast
- Chronic gastrointestinal diseases
- Primary or secondary immunodeficiency
- Severe reaction requiring hospitalization during initial food challenge
- Chronic use of beta blockers, ACE inhibitors, MAO inhibitors, proton pump inhibitors, H2 blockers, prokinetic drugs, or laxatives
- Inability to stop antihistamines for 7 days before skin testing and food challenges
- Other serious food allergies requiring intubation or ICU admission
- Women who are pregnant, breastfeeding, planning pregnancy, or not using effective contraception
- Any other medical condition or laboratory finding that poses risk or interferes with study participation as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
2
Complejo Hospittalario de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
Research Team
M
Maite Agüeros, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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