Phase 2 Study of Tezepelumab with Peanut Oral Immunotherapy for Treating Peanut Allergy in Ages 12 to 55

What this Trial Is About

Researchers are investigating the safety and effectiveness of tezepelumab combined with peanut Oral Immunotherapy OIT for treating peanut allergy in people aged 12 to 55 years. This Phase 2, double-blind, randomized placebo-controlled trial aims to find out if 56 weeks of tezepelumab plus peanut OIT can help participants tolerate peanut protein without allergic reactions after stopping the treatment. The study focuses on individuals who have allergic reactions to small amounts of peanut protein as confirmed by a food challenge test. The study has three main periods. First, participants receive either tezepelumab injections or placebo injections every four weeks for 8 weeks during the monotherapy period. Next, during the combination therapy period lasting 56 weeks, participants continue their assigned injections while gradually increasing and maintaining peanut OIT doses, starting from a very small amount up to a maintenance dose of 2000 mg peanut protein. Finally, there is a 12-week withdrawal period during which participants stop both tezepelumab or placebo injections and peanut OIT. Participants will be closely monitored throughout the trial with scheduled visits for dose escalation of peanut OIT and safety assessments. Researchers will measure how much peanut protein participants can consume without allergic symptoms during food challenges at weeks 64 and 76. They will also track any adverse events related to the treatments during all study periods. The total study duration for each participant is approximately 76 weeks, including treatment and follow-up phases.

Efficacy of Tezepelumab in Peanut Oral Immunotherapy