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NCT03679676 · ClinicalTrials.gov registry record · Phase 2
Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE)
A Phase 2 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
NCT03679676: Completed Phase 2 study, sponsored by Stanford University.
NCT03679676 is a Phase 2 study that has completed, run by Stanford University. The registered enrollment target is 130 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03679676, a Phase 2 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
Study Summary
Food allergy is a serious public health concern that causes potentially-life threatening reactions in affected patients. The prevalence of food allergy in the United States (U.S.) has increased substantially and now affects 15 million patients:4-8% of children (6 million children, 30% with multiple food allergies) and about 9% of adults. This is a prospective Phase 2, multi-center, multi-allergen OIT study in participants with proven allergies to 2 or 3 different foods in which one must be peanut. The intent-to-treat population in the clinical study will be 110 participants, ages 4 to 55 years with a history of multiple food allergies of 2 to 3 different foods including peanut. Allergy will be confirmed by food allergen (FA)-specific Immunoglobulin E (IgE) levels or positive Skin Prick Test (SPT). Enrolled participants must be positive during the Double-blind Placebo-controlled Food challenge (DBPCFC) at or before the 300 mg protein (444 mg cumulative) dosing level of FA proteins.
Interventions
- DRUG Dupilumab
- DRUG Omalizumab
- OTHER Placebo for Dupilumab
- OTHER Placebo for Omalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2020-02-05 |
| Est. Completion | 2025-05-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03679676
The ClinicalTrials.gov registry entry for NCT03679676 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Dupilumab is the first listed.
NCT03679676 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03679676 about?
NCT03679676 is a clinical study titled "Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE)". Food allergy is a serious public health concern that causes potentially-life threatening reactions in affected patients. The prevalence of food allergy in the United States (U.S.) has increased substantially and now affects 15 million patients:4-8% of children (6 million children, 30% with multiple ...
What is the current status of trial NCT03679676?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2020-02-05. Estimated completion is 2025-05-02.
What interventions are being tested in trial NCT03679676?
The interventions under investigation include: Dupilumab (DRUG), Omalizumab (DRUG), Placebo for Dupilumab (OTHER), Placebo for Omalizumab (OTHER).
Who is sponsoring clinical trial NCT03679676?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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