Gastrointestinal STRING Test With Oral Immunotherapy (STRING)
Monitoring Gastrointestinal Responses In Food Oral Immunotherapy Using the Esophageal STRING Test
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Sean N Parker Center for Allergy and Asthma Research at Stanford University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Study Population
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)
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) |
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) |
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) |
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)
Time Frame: 32 weeks
|
(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
Time Frame: 8 weeks
|
Comparison of EST scores (composite measure of eosinophilic inflammation) before and after treatment with omalizumab
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sharon Chinthrajah, MD, Stanford University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 58997
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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