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.
Who can participate
Age range12 Years – 65 Years
SexALL
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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 persiste…
What they're measuring
1
Incidence rate, severity, and relationship to treatment of adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Week 4 and Week 25
2
Number of patients experiencing any dose limiting toxicity (DLT)