Phase 2 N=108 Randomized Triple-blind Treatment

Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE)

Hypersensitivity · Food Allergy · Hypersensitivity, Food · Peanut Hypersensitivity · Peanut Allergy

Bottom Line

View on ClinicalTrials.gov: NCT03679676 ↗

Enrolled (actual)

108

Serious AEs

1.8%

Results posted

May 2026

Primary outcome: Primary: The Success Rates of Passing a Peanut Double-Blind Placebo Controlled Food Challenge (DBPCFC) — 19; 27; 3 Participants — p=0.16

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Omalizumab (Drug); Dupilumab (Drug); Placebo for Dupilumab (Other); Placebo for Omalizumab (Other)
Age: Pediatric, Adult · 4+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Apr 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY The Success Rates of Passing a Peanut Double-Blind Placebo Controlled Food Challenge (DBPCFC)	19; 27; 3	0.16
PRIMARY The Success Rates of Passing a DBPCFC to Peanut and at Least One Other FA	17; 24; 3	0.22
PRIMARY The Success Rates of Passing a DBPCFC to Peanut and Two Other FAs	6; 9; 2	0.38
SECONDARY Proportion of Participants Who Successfully Pass DBPCFCs to a Cumulative Dose of >=1,043 mg Protein to 1, 2, or 3 FAs When Applicable at Week 44	25; 38; 7; 20; 25; 3	—
SECONDARY Proportion of Participants Who Successfully Pass DBPCFCs to a Cumulative Dose of ≥2,043 mg to 1, 2, or 3 FAs When Applicable at Week 32	32; 46; 8; 30; 43; 8	—
SECONDARY Proportion of Participants Who Pass DBPCFCs for Each FA at a Cumulative Dose of ≥1,043 mg, ≥2,043 mg, or ≥4,043 mg at Week 32 and/or Week 44.	31; 45; 8; 15; 24; 5	—
SECONDARY Proportion of Participants Who Have a 10-fold Change in the Cumulative Tolerance Dose for Each FA at Weeks 32 and/or Week 44, Compared to Baseline	32; 46; 8; 15; 25; 5	—

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.

Eligibility Criteria

Inclusion Criteria

Age 4 through 55 years (inclusive).
Clinical history of peanut allergy and 1 or 2 additional foods from the following foods: milk, almond, shellfish, fish, cashew, hazelnut, egg, walnut, sesame seeds, soy, and wheat. Allergy to milk and egg is defined as unable to tolerate both cooked and uncooked forms.
Positive allergy test determined by:
ImmunoCAP serum IgE level >4 kilo Units of allergen per Liter (kUA/L) for each allergen within the past 12 months OR
Skin prick test (SPT) ≥6 mm wheal diameter to each allergen.
A clinical reaction during a DBPCFC to small doses of food defined as a cumulative dose of =/ 80% is acceptable) or;
One overnight admission to a hospital in the past year for asthma or;
Emergency room (ER) visit for asthma within six months prior to screening.
Inability to tolerate biological (antibody) therapies.
Use of immunomodulator therapy (not including corticosteroids).
Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers.
Current participation or within the last 4 months in any other interventional study.
Pregnancy or lactation.
Allergy to oat (placebo in DBPCFC).
Use of investigational drugs within 16 weeks of participation.
In build up phase of immunotherapy for aeroallergens or venom.

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Data sourced from ClinicalTrials.gov (NCT03679676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.