Gastrointestinal STRING Test With Oral Immunotherapy

Stanford University

Status and phase: Terminated; Early Phase 1

Conditions: Eosinophilic Disorder; Food Allergy

Treatments: Biological: dupliumab; Biological: omalizumab; Device: Entero-tracker

Study type: Interventional

Funder types: Other

Identifiers

NCT04943744

58997

Details and patient eligibility

About

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.

Full 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

Enrollment: 13 patients

Sex: All

Ages: 5 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 3 patient groups

String Test-cohort A

Other group

Description:

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)

Treatment:

Device: Entero-tracker

Biological: omalizumab

String Test-cohort B

Other group

Description:

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)

Treatment:

Device: Entero-tracker

Biological: omalizumab

Biological: dupliumab

String Test-cohort C

Other group

Description:

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)

Treatment:

Device: Entero-tracker

Biological: dupliumab