Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. 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.
Primary Outcome
Success is defined as passing a cumulative dose of \>=1,043 mg at the Week 44 DBPCFC if the subject has no or mild objective reactions. The primary endpoints would be compared between cohort A and cohort B. Outcome measures (rates) are presented as the percent of participants who passed, with the additional detail of the counts of participants who pass, and the participants who were analyzed.
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 |
What the finished NCT03679676 record still lists
NCT03679676 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Dupilumab is the first listed.
NCT03679676 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03679676's enrollment target sits among peer trials
130 543rd of 2000 higher than 1,448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01492036 · 130 participants
Long-Term Follow-Up of Recipient of Gene Transfer Research
- NCT01631617 · 130 participants · Phase 2
Effects of Treatments on Atopic Dermatitis
- NCT02368041 · 130 participants
Utility of Thenar Near Infrared Spectroscopy (NIRS) in Pediatric Patients With Heart Failure
- NCT02604277 · 130 participants · NA
Suicidal Behavior in Patients Diagnosed With Bipolar Disorder
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI