A phase 2 randomized controlled trial using biologics to improve multi OIT outcomes (COMBINE): design, rationale, and methods.

ABSTRACT:

Background

Food allergy remains a serious public health concern associated with significantly lowered quality of life and the risk of potentially life-threatening allergic reactions. While oral immunotherapy (OIT) has consistently demonstrated efficacy in the desensitization of multi-food allergic patients, many patients undergoing such treatment are burdened by dose-related side effects that can hinder their compliance and the overall efficacy of OIT. Recent efforts to improve upon OIT have begun to evaluate the concomitant use of biologics such as omalizumab and dupilumab with OIT for their ability to selectively inhibit pathways involved in the underlying pathology of food allergy.

Methods

Herein, we detail the clinical trial design, rationale, and methods for a Phase 2 r

SUBMITTER: Long AJ 

PROVIDER: S-EPMC12756116 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature