Gastrointestinal STRING Test With Oral Immunotherapy

NCT04943744 | Terminated Early Phase 1 FDA Drug FDA Device

• 1 other identifier: 58997
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Eosinophilic Disorder; Food Allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison of EST scores

  8 weeks

Study Arms (3)

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)

Device: Entero-tracker; Biological: omalizumab

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)

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

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)

Device: Entero-tracker; Biological: dupliumab

Interventions

Entero-tracker DEVICE

Esophageal STRING test (Entero-tracker)

String Test-cohort A; String Test-cohort B; String Test-cohort C

omalizumab BIOLOGICAL

Used in the parent study

String Test-cohort A; String Test-cohort B

dupliumab BIOLOGICAL

Used in the parent study

String Test-cohort B; String Test-cohort C

Eligibility Criteria

• Age: 5 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Able to swallow the EST.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Sean N Parker Center for Allergy and Asthma Research at Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Eosinophilia; Food Hypersensitivity

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Sharon Chinthrajah, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Clinical Research Uni

Model Details: 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 Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: May 17, 2021
• Primary Completion: May 17, 2024
• Study Completion: May 17, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)