CompletedNCT03679676Updated May 29, 2026Results posted

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

A Phase 2 interventional study of Omalizumab and Dupilumab in Hypersensitivity, Food Allergy and Hypersensitivity, Food, sponsored by Stanford University. Completed at 3 sites in United States. Open to participants aged 4 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-05-29.

Primary conditionPeanut HypersensitivityRegistry: HypersensitivityReclassifiedWhy we changed it

Registry

Hypersensitivity — the first condition term the registry derived for this study.

ClinicalTrials.gg

Peanut Hypersensitivity

Why

The study's listed conditions name Peanut Hypersensitivity, a narrower term within Hypersensitivity.

Confidence

High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →

Wrong?

Tell us the study's main condition →

Sponsored by Stanford University · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 130
Allocation: Randomized
Ages: 4 Years to 55 Years
Sex: All

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.

Read the detailed description

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 total population will be 110 participants, ages 4 to 55 years that present with a history of multiple food allergies of 2 or 3 different foods including peanut, food-allergen (FA)-specific Immunoglobulin E (IgE) levels or positive Skin Prick Test (SPT).

Enrolled participants must react positively during DBPCFCs at or before the 300 mg (444 mg cumulative) dosing level of FA proteins of 2 or 3 allergens in which one must be a peanut.

There will be three study cohorts, all will be double-blinded:

Cohort A (50 participants) will be treated with omalizumab for 8 weeks followed by 24 weeks of treatment with placebo for dupilumab. Cohort B (50 participants) will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with dupilumab. Cohort C (10 participants) will be treated with placebo for omalizumab for 8 weeks followed by 24 weeks treatment with dupilumab. All participants will receive multi-allergen OIT for peanut plus one or two additional protocol-specified foods from week 8 through week 32.

Conditions studied

Hypersensitivity
Food Allergy
Hypersensitivity, Food
Peanut Hypersensitivity
Peanut Allergy

Browse trials for

Hypersensitivity 1,055Registry's first term
Food Hypersensitivity 376
Peanut Hypersensitivity 166Primary · reclassified

Keywords

Food Allergy
Hypersensitivity, Peanut
Food Hypersensitivity
Allergy, Food

In context

Peanut Hypersensitivity Reclassified

166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.

This study's enrollment of 130 is above the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.

Browse Peanut Hypersensitivity studies →

Lead sponsor

Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.

Browse Stanford University studies →

Compared within Peanut Hypersensitivity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

Who can participate

Ages eligible: 4 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 =/\<444 mg food protein.
No clinical reaction observed during the placebo (oat) challenge.
Subject and/or parent guardian must be able to understand and provide .
Written informed consent from adult participants.
Written informed consent from parent/guardian for minor participants.
Written assent from minor participants as appropriate (e.g., at and above the age of 7 years).
Use of effective by female participants of .

Exclusion criteria

Exclusion Criteria:

History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension.
Individuals less than 15 kg in weight at start of the study
History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise or requiring intubation.
History of chronic disease (other than asthma, atopic dermatitis or allergic rhinitis) that is, or is at significant risk of becoming, unstable or requiring a change in chronic therapeutic regimen.
History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia (e.g., difficulty swallowing, food "getting stuck"), or recurrent gastrointestinal symptoms of undiagnosed etiology.
Severe asthma (NAEPP EPR-3 Medication Criteria Steps 5 or 6)
Mild or moderate asthma (NAEPP EPR-3 Medication Criteria Steps 1-4), if uncontrolled or difficult to control.
Uncontrolled asthma as evidenced by:
- \< 80% of predicted, or ratio of Forced Expiratory Volume in 1 second (FEV1) to forced vital capacity (FEV1/ Forced Vital Capacity (FVC)) \< 75% of predicted, with or without controller medications (only for age 6 or greater and able to do spirometry reliably. If unable to do spirometry, Peak Expiratory Flow (PEF) 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 ).
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 drugs within 16 weeks of participation.
In build up phase of immunotherapy for aeroallergens or venom.

Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 130 participants (actual)

Study arms

Other
Cohort A: Omalizumab
Participants will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with placebo for dupilumab.
Drug: Omalizumab · Other: Placebo for Dupilumab
Other
Cohort B: Omalizumab/Dupilumab
Participants will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with dupilumab.
Drug: Omalizumab · Drug: Dupilumab
Other
Cohort C: Dupilumab
Participants will be treated with placebo for omalizumab for 8 weeks, followed by 24 weeks of treatment with dupilumab.
Drug: Dupilumab · Other: Placebo for Omalizumab

Interventions

DrugOmalizumab
Omalizumab is injected every 2 or 4 weeks
Also known as: Xolair
DrugDupilumab
Dupilumab is injected every 2 or 4 weeks combination, or placebo.
Also known as: Dupixent
OtherPlacebo for Dupilumab
Placebo for dupilumab is injected every 2 or 4 weeks
OtherPlacebo for Omalizumab
Placebo for omalizumab is injected every 2 or 4 weeks

What researchers measure

Primary outcomes

The Success Rates of Passing a Peanut Double-Blind Placebo Controlled Food Challenge (DBPCFC)
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.
Time frame: 44 weeks
The Success Rates of Passing a DBPCFC to Peanut and at Least One Other FA
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.
Time frame: 44 weeks
The Success Rates of Passing a DBPCFC to Peanut and Two Other FAs
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.
Time frame: 44 weeks

Secondary outcomes

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
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.
Time frame: 44 weeks
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
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.
Time frame: 32 weeks
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.
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.
Time frame: week 32 and/or 44
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
Outcome measures (rates) are presented as the percent of participants who had a 10-fold change, with the additional detail of the counts of participants who had that change, and the participants who were analyzed.
Time frame: Baseline and week 32 and/or 44

Results

Posted May 29, 2026

Participant flow

Participant flow — Overall Study
Milestone	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy
Started	49	49	10
Completed at least one dbpcfc at week 44	34	45	8
Completed	34	45	8
Not completed	15	4	2
Withdrew: Adverse event	8	0	0
Withdrew: Non-compliance	3	0	0
Withdrew: Study burden	4	3	1
Withdrew: Individual safety stopping rules	0	1	1

Outcome measures

PrimaryThe Success Rates of Passing a Peanut Double-Blind Placebo Controlled Food Challenge (DBPCFC)

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.

Time frame:: 44 weeks
Reported as:: Count of participants · Participants

The Success Rates of Passing a Peanut Double-Blind Placebo Controlled Food Challenge (DBPCFC)
Participants	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy
The Success Rates of Passing a Peanut Double-Blind Placebo Controlled Food Challenge (DBPCFC)	19	27	3

Statistical analysis

Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy vs Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy · Fisher Exact · p = 0.16 (the a priori threshold for statistical significance was \<0.05) · Odds ratio (or): 1.9 · 95% CI 0.8 to 4.7Binomial exact

PrimaryThe Success Rates of Passing a DBPCFC to Peanut and at Least One Other FA

Time frame:: 44 weeks
Reported as:: Count of participants · Participants

The Success Rates of Passing a DBPCFC to Peanut and at Least One Other FA
Participants	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy
The Success Rates of Passing a DBPCFC to Peanut and at Least One Other FA	17	24	3

Statistical analysis

Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy vs Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy · Fisher Exact · p = 0.22 (the a priori threshold for statistical significance was \<0.05) · Odds ratio (or): 1.8 · 95% CI 0.7 to 4.4Binomial exact

PrimaryThe Success Rates of Passing a DBPCFC to Peanut and Two Other FAs

Time frame:: 44 weeks
Reported as:: Count of participants · Participants

The Success Rates of Passing a DBPCFC to Peanut and Two Other FAs
Participants	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy
The Success Rates of Passing a DBPCFC to Peanut and Two Other FAs	6	9	2

Statistical analysis

Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy vs Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy · Fisher Exact · p = 0.38 · Odds ratio (or): 1.8 · 95% CI 0.47 to 7.11

SecondaryProportion 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

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.

Time frame:: 44 weeks
Reported as:: Count of participants · Participants

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
Participants	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy
Any one allergen	25	38	7
Any two allergens	20	25	3

SecondaryProportion 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

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.

Time frame:: 32 weeks
Reported as:: Count of participants · Participants

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
Participants	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy
Any one allergen	32	46	8
Any two allergens	30	43	8
Three Allergens	17	22	2

SecondaryProportion 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.

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.

Time frame:: week 32 and/or 44
Reported as:: Count of participants · Participants

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.
Participants	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy
Peanut	31	45	8
Cashew	15	24	5
Walnut	17	12	6
Hazelnut	6	10	1
Egg	4	8	0

SecondaryProportion 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

Outcome measures (rates) are presented as the percent of participants who had a 10-fold change, with the additional detail of the counts of participants who had that change, and the participants who were analyzed.

Time frame:: Baseline and week 32 and/or 44
Reported as:: Count of participants · Participants

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
Participants	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy
Peanut	32	46	8
Cashew	15	25	5
Walnut	17	12	6
Hazelnut	6	9	1
Egg	4	8	0

Adverse events

Collected over From Week 0 to Week 44. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy	0/49 (0%)	0/49 (0%)	34/49 (69.4%)
Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	0/49 (0%)	1/49 (2%)	39/49 (79.6%)
Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	0/10 (0%)	1/10 (10%)	7/10 (70%)

Most frequent serious events

Most frequent serious events
Event	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy
Itchy mouth/throat/lips/tongueGastrointestinal disorders	0/49	0/49	1/10
Stomach painGastrointestinal disorders	0/49	0/49	1/10
DizzinessNervous system disorders	0/49	0/49	1/10
HypotensionVascular disorders	0/49	1/49	1/10
Abdominal painGastrointestinal disorders	0/49	1/49	0/10
NauseaGastrointestinal disorders	0/49	1/49	0/10
VomitingGastrointestinal disorders	0/49	1/49	0/10
Nasal congestionRespiratory, thoracic and mediastinal disorders	0/49	1/49	0/10
UrticariaSkin and subcutaneous tissue disorders	0/49	1/49	0/10
FlushingVascular disorders	0/49	1/49	0/10

Most frequent other events

Showing 10 of 27

Most frequent other events
Event	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy
UrticariaSkin and subcutaneous tissue disorders	5/49	11/49	4/10
Abdominal painGastrointestinal disorders	10/49	12/49	3/10
Itchy mouth/throat/lips/tongueGastrointestinal disorders	5/49	8/49	3/10
VomitingGastrointestinal disorders	14/49	3/49	1/10
Injection site reactionGeneral disorders	9/49	12/49	0/10
NauseaGastrointestinal disorders	11/49	4/49	2/10
DiarrheaGastrointestinal disorders	1/49	3/49	2/10
Edema faceGeneral disorders	1/49	2/49	2/10
CoughRespiratory, thoracic and mediastinal disorders	5/49	9/49	2/10
WheezingRespiratory, thoracic and mediastinal disorders	3/49	6/49	2/10

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Total
Mean	12.14 ± 6.66	13.08 ± 7.22	10.15 ± 3.42	12.38 ± 6.71

Sex: Female, Male
Sex: Female, Male(Participants)	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Total
Female	16	15	4	35
Male	33	34	6	73

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Total
Hispanic or Latino	2	4	1	7
Not Hispanic or Latino	46	43	9	98
Unknown or Not Reported	1	2	0	3

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Total
American Indian or Alaska Native	0	0	0	0
Asian	15	19	3	37
Native Hawaiian or Other Pacific Islander	0	2	0	2
Black or African American	2	1	0	3
White	18	15	1	34
More than one race	13	11	4	28
Unknown or Not Reported	1	1	2	4

Region of Enrollment
Region of Enrollment(Participants)	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Total
United States	49	49	10	108

Atopic Disorder
Atopic Disorder(Participants)	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Total
Asthma	31	30	3	64
Atopic Dermatitis	43	41	9	93
Allergic Rhinitis	32	25	6	63

Number of Allergens
Number of Allergens(Participants)	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	Total
3 food allergens	31	30	6	67
2 food allergens	18	19	4	41

Study locations

3 sites

University of California Los Angeles (UCLA)
Los Angeles, California 90095, United States
Sean N. Parker Center for Allergy & Asthma Research at Stanford University
Palo Alto, California 94304, United States
University of California San Diego (UCSD)
San Diego, California 92123, United States

References and documents

Publications

Long AJ, Sindher S, Martinez K, Choi JH, Albarran M, Schuetz J, Parry A, Tang J, Garcia Llorett M, Zedeck SS, Grissinger A, Kiernan E, Leonard S, Raeber O, Feight C, Anderson B, Sharma R, Bogetic D, Chin AR, Woch M, Poyser J, Laurienzo Panza J, Togias A, Wheatley L, Boyd S, Galli SJ, Nadeau KC, Chinthrajah RS. A phase 2 randomized controlled trial using biologics to improve multi OIT outcomes (COMBINE): design, rationale, and methods. Front Allergy. 2025 Dec 18;6:1729111. doi: 10.3389/falgy.2025.1729111. eCollection 2025. PubMed 41488220 ↗
Ghelli C, Costanzo G, Canonica GW, Heffler E, Paoletti G. New evidence in food allergies treatment. Curr Opin Allergy Clin Immunol. 2024 Aug 1;24(4):251-256. doi: 10.1097/ACI.0000000000000999. Epub 2024 May 30. PubMed 38814736 ↗

Study documents

Protocol and statistical analysis plan ↗ · Feb 3, 2025
Statistical analysis plan ↗ · Nov 17, 2025
Informed consent form ↗ · Mar 11, 2025

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2020 to primary completion in Apr 2025, 62 months.

Results were first posted in May 2026, 1 year 1 month after primary completion.

Of 18 phase 2 interventional studies under Peanut Hypersensitivity, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 58. This study's 62 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 19, 2018
First posted: Sep 20, 2018
StartActual: Feb 5, 2020
Primary completionActual: Apr 15, 2025
CompletionActual: May 2, 2025
Results first posted: May 29, 2026
Last update: May 29, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03679676
Lead sponsor: Stanford University
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Food Allergy Research & Education, Harvard School of Public Health (HSPH)
Responsible party: R. Sharon Chinthrajah (Medical Director, Clinical Research Unit, Stanford University) — Principal investigator
First posted: Sep 20, 2018
Start date: Feb 5, 2020
Primary completion: Apr 15, 2025
Completion: May 2, 2025
Results posted: May 29, 2026
Last update: May 29, 2026

Study contacts

Rebecca S Chinthrajah, M.D.

study director · Sean N Parker Center for Allergy and Asthma Center at Stanford

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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