Actively Recruiting
A Multicenter Double-blind, Randomized, Placebo-controlled Study to Determine Safety, Tolerability, and Dose Finding of INP20 Oral Immunotherapy in Peanut-allergic Patients
Led by InnoUp Farma S.L. · Updated on 2025-04-30
50
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating INP20, an oral immunotherapy for people aged 12 to 65 with peanut allergy. This study aims to determine the safety, tolerability, potential efficacy, and the best dose of INP20. It is a phase I/II trial with a double-blind, randomized, placebo-controlled design conducted at multiple centers. The study has two parts. Part A involves six groups each receiving different daily doses of INP20 for 2 weeks to find the appropriate dose. Part B lasts 6 months, where participants are randomly assigned to receive either placebo or one of two doses of INP20 selected from Part A, taken once daily. Participants will be monitored for side effects and immune responses, including blood tests and food challenge tests to measure reaction thresholds to peanut. Safety and dose limiting toxicities are assessed at weeks 2, 4, and 25. The study tracks allergy-related immune changes and allergic reactions over the treatment period, with participation lasting up to 6 months or more.
CONDITIONS
Brief Title
Oral Immunotherapy for Peanut Allergic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of specific IgE to peanuts confirmed by positive skin prick test (wheal > 3.0 mm) and positive peanut IgE test (> 0.35 kUA/L)
- History of significant allergic symptoms within 60 minutes after eating peanuts
- Positive double-blind placebo-controlled food challenge to peanuts at less than 10 grams of peanut protein
- Signed informed consent to participate in the study
- Have self-injectable epinephrine available at home and trained on its use
- Potentially fertile women must 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, hypoxemia (O2 saturation <92%), severe breathing difficulty, hypotension, loss of consciousness, or sphincter relaxation
- Participation in another investigational drug study currently
- Participation in oral or sublingual immunotherapy for food allergy in 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
- Prior intubation or mechanical ventilation for asthma
- 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, prokinetics, or laxatives
- Inability to stop antihistamines for 7 days before testing
- Serious other food allergies requiring ICU or intubation
- Pregnant, breastfeeding, or planning pregnancy without effective contraception
- Medical problems that may increase risk or interfere with study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants begin oral administration of INP20 or placebo at ascending doses once daily to establish tolerability.
Weekly visits for up to 2 weeks
Duration - 6 months
Participants continue oral INP20 or placebo once daily following the initial dose escalation for 6 months.
Monthly visits during treatment period
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
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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