Gastrointestinal STRING Test With Oral Immunotherapy

Study Overview
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Brief Summary
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This STRING study will examine markers of esophageal inflammation using a minimally-invasive testing device, the esophageal string test (EST). The primary objective is to determine the effect of omalizumab (Xolair) and dupilumab (Dupixent) on markers of eosinophilic inflammation in the esophagus of subjects treated with omalizumab-facilitated mOIT(mult-allergen oral immunotherapy) and/or mOIT with concurrent dupilumab.

Detailed Description
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This is a companion study to a phase 2 randomized, controlled, double-blind clinical trial using biologics to improve multi-allergen oral immunotherapy (mOIT) outcomes. The parent study (COMBINE NCT03679676) consists of a screening period, 8 weeks of omalizumab or placebo injections, and 24 weeks of OIT with dupilumab or placebo injections followed by an off-treatment period. This STRING companion study will examine markers of esophageal inflammation during the COMBINE study using a minimally-invasive testing device, the esophageal string test (EST). If participants of COMBINE consent to this companion study, they will undergo an esophageal string test at the following time points in COMBINE: During screening, prior to week 0, which will be baseline for the STRING esophageal test Week 8, After the 8 weeks of treatment with omalizumab/placebo If dose-related gastrointestinal (GI) side effects occur during the week 10-32 treatment period (OIT and dupilumab/placebo) At Week 32, after 24 weeks of treatment with OIT and dupilumab or placebo

Official Title
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Monitoring Gastrointestinal Responses In Food Oral Immunotherapy Using the Esophageal STRING Test

Conditions
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Eosinophilic Disorder, Food Allergy

Intervention / Treatment
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* Device: Entero-tracker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Participants, aged 5-55 years enrolled in the parent COMBINE trial Able to swallow the EST. Exclusion Criteria: • Allergy to, or inability to ingest, gelatin -

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| String Test<br>Participants in the COMBINE study will have an EST performed at pre- specified timepoints (screening, week 8, and week 32) and as needed depending on GI symptoms. | Device: Entero-tracker<br>* Esophageal STRING test (Entero-tracker)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the proportion of subjects with esophageal eosinophilia (EE) | (defined as an EST score ≥ 2.9) in subjects receiving omalizumab-facilitated mOIT and/or mOIT with concurrent | 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of EST scores | Comparison of EST scores (composite measure of eosinophilic inflammation) before and after treatment with omalizumab | 8 weeks |