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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04943744
Other study ID # 58997
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 17, 2021
Est. completion date September 2025

Study information

Verified date November 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 50
Est. completion date September 2025
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 5 Years to 55 Years
Eligibility 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 -

Study Design


Intervention

Device:
Entero-tracker
Esophageal STRING test (Entero-tracker)

Locations

Country Name City State
United States Sean N Parker Center for Allergy and Asthma Research at Stanford University Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Comparison of EST scores Comparison of EST scores (composite measure of eosinophilic inflammation) before and after treatment with omalizumab 8 weeks
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