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Parent study closed to enrollment
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| String Test-cohort A | Other | 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) |
|
| String Test-cohort B | Other | 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) |
|
| String Test-cohort C | Other | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entero-tracker | Device | Esophageal STRING test (Entero-tracker) |
|
| 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 |
| 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 |
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Inclusion Criteria: • Participants, aged 5-55 years enrolled in the parent COMBINE trial
Exclusion Criteria: • Allergy to, or inability to ingest, gelatin
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Chinthrajah, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sean N Parker Center for Allergy and Asthma Research at Stanford University | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D004802 | Eosinophilia |
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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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:
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| omalizumab | Biological | Used in the parent study |
|
| dupliumab | Biological | Used in the parent study |
|
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |