HypersensitivityPhase 2NCT03679676

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

A Phase 2 study testing Omalizumab and Dupilumab in people with Hypersensitivity and Food Allergy, run by Stanford University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 4 to 55 years
Conditions the study is for: Hypersensitivity, Food Allergy, Hypersensitivity, Food
What is being tested?: Omalizumab and Dupilumab
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 130 participants
Where: 3 sitesUnited States
Study dates: 5 Feb 2020to 2 May 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 55 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Show all 12Show fewer

No clinical reaction observed during the placebo (oat) challenge.
Subject and/or parent guardian must be able to understand and provide informed consent.
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 birth control by female participants of childbearing potential.

Who cannot join

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)

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Mild or moderate asthma (NAEPP EPR-3 Medication Criteria Steps 1-4), if uncontrolled or difficult to control.
Uncontrolled asthma as evidenced by:
FEV1 < 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 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

Other trials in United States

About this study

Official title: Phase 2 Randomized Controlled Trial Using Biologics to Improve Multi OIT Outcomes

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: Hypersensitivity, Food Allergy, Hypersensitivity, Food, Peanut Hypersensitivity, Peanut Allergy
Being tested: Omalizumab, Dupilumab, Placebo for Dupilumab, Placebo for Omalizumab
Keywords: Food Allergy, Hypersensitivity, Peanut, Food Hypersensitivity, Allergy, Food
Medical subject headings: Hypersensitivity, Food Hypersensitivity, Peanut Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OmalizumabDrug
Also called Xolair
Omalizumab is injected every 2 or 4 weeks
DupilumabDrug
Also called Dupixent
Dupilumab is injected every 2 or 4 weeks
combination, or placebo.
Placebo for DupilumabOther
Placebo for dupilumab is injected every 2 or 4 weeks
Placebo for OmalizumabOther
Placebo for omalizumab is injected every 2 or 4 weeks

Study groups in NCT03679676
Study group	Role	What they receive
Cohort A: Omalizumab	Other	Participants will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with placebo for dupilumab. Receives: Drug: Omalizumab; Other: Placebo for Dupilumab
Cohort B: Omalizumab/Dupilumab	Other	Participants will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with dupilumab. Receives: Drug: Omalizumab; Drug: Dupilumab
Cohort C: Dupilumab	Other	Participants will be treated with placebo for omalizumab for 8 weeks, followed by 24 weeks of treatment with dupilumab. Receives: Drug: Dupilumab; Other: Placebo for Omalizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 44 weeks

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and week 32 and/or 44

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Feb 20202 May 2025

First posted20 Sep 2018
Study start5 Feb 2020
Primary completion15 Apr 2025
Study completion2 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HypersensitivityStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a prospective Phase 2, multi-site, multi-allergen OIT in participants with proven allergies to 2 or 3 different foods in which one must be peanut. Our intent to treat population will be 110 participants, ages 4 to 55 years with a history of multiple food allergies of 2 or 3 different foods including peanut. Allergy will be confirmed by FA-specific IgE levels and positive skin prick test (SPT). Enrolled participants must be positive during the DBPCFCs at or before the 300 mg (444 mg cumulative) dosing level of FA proteins.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03679676
Sponsor's protocol ID: IRB-47935
Other IDs: 5U19AI104209-07
Status last verified: May 2026
First submitted: 19 Sep 2018
Last updated: 29 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Randomized Controlled Trial Using Biologics to Improve Multi OIT Outcomes
ClinicalTrials.gov ID: NCT03679676
Acronym / sponsor ID: IRB-47935
Conditions: Hypersensitivity, Food Allergy, Hypersensitivity, Food, Peanut Hypersensitivity, Peanut Allergy
Keywords: Food Allergy, Hypersensitivity, Peanut, Food Hypersensitivity, Allergy, Food
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Food Allergy Research & Education, Harvard School of Public Health (HSPH)
Study start: 5 Feb 2020 (actual)
Primary completion: 15 Apr 2025 (actual)
Study completion: 2 May 2025 (actual)
First posted: 20 Sep 2018 (actual)
Results: Posted 29 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3
Model description: This is a prospective Phase 2, multi-site, multi-allergen OIT in participants with proven allergies to 2 or 3 different foods in which one must be peanut. Our intent to treat population will be 110 participants, ages 4 to 55 years with a history of multiple food allergies of 2 or 3 different foods including peanut. Allergy will be confirmed by FA-specific IgE levels and positive skin prick test (SPT). Enrolled participants must be positive during the DBPCFCs at or before the 300 mg (444 mg cumulative) dosing level of FA proteins.

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

Who may qualify

Ages: 4 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (12 listed)

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.

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OmalizumabAlso: XolairOmalizumab is injected every 2 or 4 weeks	Drug	Cohort A: Omalizumab, Cohort B: Omalizumab/Dupilumab
DupilumabAlso: DupixentDupilumab is injected every 2 or 4 weeks combination, or placebo.	Drug	Cohort B: Omalizumab/Dupilumab, Cohort C: Dupilumab
Placebo for DupilumabPlacebo for dupilumab is injected every 2 or 4 weeks	Other	Cohort A: Omalizumab
Placebo for OmalizumabPlacebo for omalizumab is injected every 2 or 4 weeks	Other	Cohort C: Dupilumab

Primary outcome

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

4 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
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
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.
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
Time frame: Baseline and week 32 and/or 44

Results and safety

Results posted to the registry on 29 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy	49	34
Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	49	45
Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy	10	8

Primary outcome: The Success Rates of Passing a Peanut Double-Blind Placebo Controlled Food Challenge (DBPCFC)

Time frame: 44 weeks. Count of participants. Unit: Participants

Measure	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy n = 49	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n = 49	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n = 10
Value	19	27	3

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: Odds Ratio (OR): 1.9 (95% CI 0.8 to 4.7), p = 0.16, Fisher Exact

Primary outcome: The Success Rates of Passing a DBPCFC to Peanut and at Least One Other FA

Time frame: 44 weeks. Count of participants. Unit: Participants

Measure	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy n = 49	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n = 49	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n = 10
Value	17	24	3

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: Odds Ratio (OR): 1.8 (95% CI 0.7 to 4.4), p = 0.22, Fisher Exact

Primary outcome: The Success Rates of Passing a DBPCFC to Peanut and Two Other FAs

Time frame: 44 weeks. Count of participants. Unit: Participants

Measure	Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy n = 31	Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n = 30	Cohort C: Placebo for Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy n = 6
Value	6	9	2

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: Odds Ratio (OR): 1.8 (95% CI 0.47 to 7.11), p = 0.38, Fisher Exact

Population analysed: Participants who had 3 allergens as part of their OIT.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Week 0 to Week 44. Other adverse events reported at 5% frequency or more

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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 41488220Long 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.
Derived from this study: PubMed 38814736Ghelli 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.
Sean N. Parker Center for Allergy and Asthma ResearchLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rebecca S Chinthrajah, M.D. study director

Sean N Parker Center for Allergy and Asthma Center at Stanford

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Omalizumab and Dupilumab in people with Hypersensitivity and Food Allergy, run by Stanford University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Success Rates of Passing a Peanut Double-Blind Placebo Controlled Food Challenge (DBPCFC) (time frame: 44 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03679676, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.