Gastrointestinal STRING Test With Oral Immunotherapy (STRING)

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

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.

Study Overview

• Status: Terminated
• Conditions: Food Allergy; Eosinophilic Disorder
• Intervention / Treatment: Device: Entero-tracker

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Sean N Parker Center for Allergy and Asthma Research at Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No

Study Population

Participants in the COMBINE study

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: String Test-cohort A; 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. A. Omalizumab for 8 weeks followed by mOIT with placebo for dupilumab for 24 weeks (Cohort A: Omalizumab-facilitated mOIT)	Device: Entero-tracker; Esophageal STRING test (Entero-tracker)
Other: String Test-cohort B; 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. B. Omalizumab for 8 weeks followed by mOIT with dupilumab for 24 weeks (Cohort B: Omalizumab-facilitated mOIT with concurrent dupilumab)	Device: Entero-tracker; Esophageal STRING test (Entero-tracker)
Other: String Test-cohort C; 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. C. Placebo for omalizumab for 8 weeks followed by mOIT with dupilumab for 24 weeks (Cohort C: mOIT with concurrent dupilumab)	Device: Entero-tracker; Esophageal STRING test (Entero-tracker)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Sharon Chinthrajah, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Actual): May 17, 2024
• Study Completion (Actual): May 17, 2024

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Hypersensitivity; Leukocyte Disorders; Eosinophilia; Food Hypersensitivity
• Other Study ID Numbers: 58997

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes