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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Part A: Oral INP20 administration at ascending doses once daily for 2 weeks. Part B: Two doses of oral INP20 derived from Part A once daily for 6 months.
Part A: Oral placebo administration onces daily for 2 weeks. Part B: Oral placebo administration onces daily for 6 months.
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
RECRUITINGComplejo Hospittalario de Navarra
Pamplona, Navarre, Spain
RECRUITINGIncidence rate, severity, and relationship to treatment of adverse events (AEs) and serious adverse events (SAEs)
Safety of the investigational product
Time frame: Week 4 and Week 25
Number of patients experiencing any dose limiting toxicity (DLT)
Tolerability of the investigational product
Time frame: Week 2
Change in Immunoglobulin G subtype (IgG4) and basophil activation on the BAT (basophil activation test).
Pharmacodynamics
Time frame: Week 4
Differences in reaction thresholds (challenge test) to peanut of treatment groups versus the placebo after 6 months of INP20 treatment.
Efficacy of the investigational product
Time frame: Week 24
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