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
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Peanut Allergy
- Sponsor
- InnoUp Farma S.L.
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Incidence rate, severity, and relationship to treatment of adverse events (AEs) and serious adverse events (SAEs)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
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.
Arms & Interventions
Placebo
Intervention: Placebo
INP20 (Oral Immunotherapy)
Intervention: INP20
Outcomes
Primary Outcomes
Incidence rate, severity, and relationship to treatment of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Week 4 and Week 25
Safety of the investigational product
Number of patients experiencing any dose limiting toxicity (DLT)
Time Frame: Week 2
Tolerability of the investigational product
Secondary Outcomes
- Differences in reaction thresholds (challenge test) to peanut of treatment groups versus the placebo after 6 months of INP20 treatment.(Week 24)
- Change in Immunoglobulin G subtype (IgG4) and basophil activation on the BAT (basophil activation test).(Week 4)