Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
EARLY_PHASE1
13 participants
INTERVENTIONAL
2021-05-17
2024-05-17
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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
DIAGNOSTIC
NONE
Study Groups
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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)
Entero-tracker
Esophageal STRING test (Entero-tracker)
omalizumab
Used in the parent study
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)
Entero-tracker
Esophageal STRING test (Entero-tracker)
omalizumab
Used in the parent study
dupliumab
Used in the parent study
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)
Entero-tracker
Esophageal STRING test (Entero-tracker)
dupliumab
Used in the parent study
Interventions
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Entero-tracker
Esophageal STRING test (Entero-tracker)
omalizumab
Used in the parent study
dupliumab
Used in the parent study
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
5 Years
55 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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R. Sharon Chinthrajah
Medical Director, Clinical Research Uni
Principal Investigators
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Sharon Chinthrajah, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Sean N Parker Center for Allergy and Asthma Research at Stanford University
Palo Alto, California, United States
Countries
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Other Identifiers
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58997
Identifier Type: -
Identifier Source: org_study_id
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