Study of Oral Immunotherapy INP20 for Treating Peanut Allergy in Patients Aged 12 to 65 Years Double-Blind, Randomized, Placebo-Controlled Phase III Trial to Find Safe and Effective Doses

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 III 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.

Oral Immunotherapy for Peanut Allergic Patients