Oral Immunotherapy for Peanut Allergic Patients

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.

Timeline

Start

2020-03-11

Primary completion

2025-05

Completion

2025-09

Drugs

Indications