Study of VE416 with Low-Dose Peanut Oral Immunotherapy for Treating Peanut Allergy in Ages 12 to 55

What this Trial Is About

Researchers are evaluating the investigational medicine VE416 combined with vancomycin and peanut oral immunotherapy PNOIT for people with persistent peanut allergy. This randomized, double-blind trial has four groups comparing VE416 given before or during PNOIT to low-dose PNOIT alone, aiming to see if VE416 may help reduce allergic reactions and is safe to use. The study includes four arms one with vancomycin then VE416 before starting PNOIT another with vancomycin and VE416 taken together with PNOIT a third with placebo vancomycin and active VE416 with PNOIT and a fourth with placebo vancomycin and placebo VE416 alongside active PNOIT. Treatments involve capsules taken daily for specified periods, with vancomycin given for 5 days and VE416 for 6 weeks in different sequences depending on the group. Participants aged 12 to 55 with a diagnosed peanut allergy will be involved over several phases lasting up to 54 weeks. They will undergo evaluations including allergy testing, monitoring for allergic reactions, and safety assessments. The main outcomes measured include the response after 7 and 23 weeks and longer-term efficacy and safety through 54 weeks. The study includes a maintenance phase and a blinded food challenge to assess tolerance.

VE416 for Treatment of Food Allergy