Food AllergyPhase 2NCT03181009
Multi OIT to Test Immune Markers After Minimum Maintenance Dose
A Phase 2 study testing Omalizumab and Food Flour Allergens in people with Food Allergy, run by Andrew Long, PharmD at 2 sites in United States.
Trial summary
Few studies have been conducted to optimize safety of multiple food allergen oral immunotherapy (OIT) in conjunction with Omalizumab as well as to identify the immunological mechanism(s) underlying any long-lasting effects of OIT. Read more about this study
- Who is it for?
- Ages 2 to 25 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- Omalizumab and Food Flour Allergens
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jul 2017to 30 Jan 2019
- 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 2 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 2 to 25 years with clinical history of allergy to at least two of the following: milk and/or egg and/or peanut and/or almond and/or wheat and/or cashew and/or sesame seed and/or soy and/or pecan and/or walnut and/or hazelnut and/or shrimp and/or cod and/or salmon and
- Sensitivity to food allergens documented by a positive skin prick test result greater than or equal to 6mm wheal diameter to each allergen or
- ImmunoCAP IgE level >4kU/L for each allergen and
- If female of child bearing potential, a negative urine pregnancy test before being allowed to participate in the study (week 0) and
- A plan to remain in the study area of the research center during the trial and
- Be trained on the proper use of the Epinephrine autoinjector and agree to follow epi training to be allowed to enroll in the study and
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- If female of child-bearing potential, willing to be compliant with a medically-approved method of contraception (please see Pregnancy section in this IND document) and
- Agree to eliminate other known food allergens from subject's diet so as not to confound the safety and efficacy data from the study and
- Avoid open or blinded food challenges to food allergens
Who cannot join
- Previous anaphylactic reaction to Omalizumab
- A history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma
- Unstable angina, significant arrhythmia, uncontrolled hypertension, chronic sinusitis, or other chronic or immunological diseases that, in the judgment of the investigator, might interfere with the evaluation or administration of the test drug or pose additional risk to the subject (e.g., gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease)
- An average forced expiratory volume at one second (FEV1) or peak expiratory flow rate (PEF) less than 80% predicted (moderate persistent asthma) with or without controller medication (if able to perform the maneuver) at screening, or a food challenge visit
- Current users of oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants, or are taking a beta-blocker (oral or topical)
- Routinely using medication that could induce adverse gastrointestinal reactions during the study
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- Refusing to sign or follow the Epinephrine autoinjector Training Form
- Pregnant or breast feeding women
- Unwilling to avoid other allergens outside this study
- Concurrent/prior use of immunomodulatory therapy (within 6 months)
- A diagnosis of eosinophilic esophagitis, eosinophilic colitis, or eosinophilic gastritis.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCLA
Los Angeles, California, 90095
Sean N. Parker Center for Allergy and Asthma Research at Stanford
Mountain View, California, 94040
About this study
Official title: A Phase 2 Study Multi Oral Immunotherapy in Multi Food Allergic Patients to Test Immune Markers After Minimum Maintenance Dose
Few studies have been conducted to optimize safety of multiple food allergen oral immunotherapy (OIT) in conjunction with Omalizumab as well as to identify the immunological mechanism(s) underlying any long-lasting effects of OIT. To address these issues in the field of food allergy research, we have designed this study to test whether: 1) Omalizumab improves the safety of multiple food allergen OIT in subjects with multi food allergies, 2) Omalizumab treatment with multiple food allergen OIT is associated with the ability to use a lower maintenance dose of each food allergens in the OIT regimen, particularly in younger subjects with food allergies.
Read the detailed description
This is a phase 2 multisite study that will be conducted at two centers in the U.S. All subjects will receive oral immunotherapy for their specific food allergies (peanut, milk, egg, soy, wheat, cashew, walnut, almond, hazelnut, cod, salmon, sesame, shrimp). All participants will receive three doses of Omalizumab 4 weeks apart over 8 weeks. The subject's allergens will be introduced after receiving the third omalizumab dose. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B.
Food protein and powder will be obtained and prepared as per Investigational New Drug 14831 and will be in compliance with all applicable regulations.
Omalizumab is approved by the European Medicines Agency (European FDA) and by the US FDA. Omalizumab will be dosed according to Genentech Dosing Omalizumab will be provided by the site.
- Conditions
- Food Allergy
- Being tested
- Omalizumab, Food Flour Allergens
- Keywords
- Oral Immunotherapy, Omalizumab, OIT, Xolair
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
Also called Xolair
All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.
Food Flour AllergensDrug
Also called Food flours
The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle.
| Study group | Role | What they receive |
|---|---|---|
| Group A (300 mg maintenance dose) | Experimental | After initial therapy with omalizumab Group A subjects will escalate their food flour allergens to 300 mg in 18 weeks. Receives: Drug: Omalizumab; Drug: Food Flour Allergens |
| Group B (1200 maintenance dose) | Active comparator | After initial therapy with omalizumab Group B subjects will escalate their food flour allergens to 1200 mg in 18 weeks. Receives: Drug: Omalizumab; Drug: Food Flour Allergens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Allergen-specific Serum IgG4 and IgE
Change in allergen-specific serum IgG4 and IgE from baseline to Week 18 (End of Study)
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start31 Jul 2017
- Primary completion1 Dec 2018
- Study completion30 Jan 2019
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 (1)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- 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 phase 2 multi site study that will be conducted at two centers in the U.S. All subjects will receive oral immunotherapy for their specific food allergies (peanut, egg, milk, wheat, soy, cashew, walnut, almond, hazelnut, sesame seed, cod, salmon and shrimp). All participants will receive three doses of Omalizumab 4 weeks apart over 8 weeks. The subject's allergens will be introduced after receiving the third omalizumab dose. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Long, PharmD
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Sayantani B. Sindher, Stanford University
- Investigators
- Kari C Nadeau, MD PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181009
- Sponsor's protocol ID
- eProtocol 39519
- Status last verified
- Apr 2020
- First submitted
- 7 Apr 2017
- Last updated
- 27 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: pending
Publications
Sindher SB, Kumar D, Cao S, Purington N, Long A, Sampath V, Zedeck SS, Woch MA, Garcia-Lloret M, Chinthrajah RS. Phase 2, randomized multi oral immunotherapy with omalizumab 'real life' study. Allergy. 2022 Jun;77(6):1873-1884. doi: 10.1111/all.15217. Epub 2022 Jan 24.
PubMed 35014049
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study Multi Oral Immunotherapy in Multi Food Allergic Patients to Test Immune Markers After Minimum Maintenance Dose
- ClinicalTrials.gov ID
- NCT03181009
- Acronym / sponsor ID
- eProtocol 39519
- Conditions
- Food Allergy
- Keywords
- Oral Immunotherapy, Omalizumab, OIT, Xolair
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Andrew Long, PharmDUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 8 Jun 2017 (actual)
- Results
- Posted 20 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Few studies have been conducted to optimize safety of multiple food allergen oral immunotherapy (OIT) in conjunction with Omalizumab as well as to identify the immunological mechanism(s) underlying any long-lasting effects of OIT. To address these issues in the field of food allergy research, we have designed this study to test whether: 1) Omalizumab improves the safety of multiple food allergen OIT in subjects with multi food allergies, 2) Omalizumab treatment with multiple food allergen OIT is associated with the ability to use a lower maintenance dose of each food allergens in the OIT regimen, particularly in younger subjects with food allergies.
Detailed description
This is a phase 2 multisite study that will be conducted at two centers in the U.S. All subjects will receive oral immunotherapy for their specific food allergies (peanut, milk, egg, soy, wheat, cashew, walnut, almond, hazelnut, cod, salmon, sesame, shrimp). All participants will receive three doses of Omalizumab 4 weeks apart over 8 weeks. The subject's allergens will be introduced after receiving the third omalizumab dose. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B.
Food protein and powder will be obtained and prepared as per Investigational New Drug 14831 and will be in compliance with all applicable regulations.
Omalizumab is approved by the European Medicines Agency (European FDA) and by the US FDA. Omalizumab will be dosed according to Genentech Dosing Omalizumab will be provided by the site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a phase 2 multi site study that will be conducted at two centers in the U.S. All subjects will receive oral immunotherapy for their specific food allergies (peanut, egg, milk, wheat, soy, cashew, walnut, almond, hazelnut, sesame seed, cod, salmon and shrimp). All participants will receive three doses of Omalizumab 4 weeks apart over 8 weeks. The subject's allergens will be introduced after receiving the third omalizumab dose. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B.
| Arm | Type | Receives |
|---|---|---|
| Group A (300 mg maintenance dose) | Experimental | Drug: Omalizumab, Drug: Food Flour AllergensAfter initial therapy with omalizumab Group A subjects will escalate their food flour allergens to 300 mg in 18 weeks. |
| Group B (1200 maintenance dose) | Active comparator | Drug: Omalizumab, Drug: Food Flour AllergensAfter initial therapy with omalizumab Group B subjects will escalate their food flour allergens to 1200 mg in 18 weeks. |
Who may qualify
- Ages
- 2 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Aged 2 to 25 years with clinical history of allergy to at least two of the following: milk and/or egg and/or peanut and/or almond and/or wheat and/or cashew and/or sesame seed and/or soy and/or pecan and/or walnut and/or hazelnut and/or shrimp and/or cod and/or salmon and
- Sensitivity to food allergens documented by a positive skin prick test result greater than or equal to 6mm wheal diameter to each allergen or
- ImmunoCAP IgE level >4kU/L for each allergen and
- If female of child bearing potential, a negative urine pregnancy test before being allowed to participate in the study (week 0) and
- A plan to remain in the study area of the research center during the trial and
Key exclusion criteria (11 listed)
- Previous anaphylactic reaction to Omalizumab
- A history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma
- Unstable angina, significant arrhythmia, uncontrolled hypertension, chronic sinusitis, or other chronic or immunological diseases that, in the judgment of the investigator, might interfere with the evaluation or administration of the test drug or pose additional risk to the subject (e.g., gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease)
- An average forced expiratory volume at one second (FEV1) or peak expiratory flow rate (PEF) less than 80% predicted (moderate persistent asthma) with or without controller medication (if able to perform the maneuver) at screening, or a food challenge visit
- Current users of oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants, or are taking a beta-blocker (oral or topical)
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: XolairAll subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg. | Drug | Group A (300 mg maintenance dose), Group B (1200 maintenance dose) |
| Food Flour AllergensAlso: Food floursThe subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle. | Drug | Group A (300 mg maintenance dose), Group B (1200 maintenance dose) |
Primary outcome
Change in Allergen-specific Serum IgG4 and IgE
Time frame: 18 weeks
Change in allergen-specific serum IgG4 and IgE from baseline to Week 18 (End of Study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35014049Sindher SB, Kumar D, Cao S, Purington N, Long A, Sampath V, Zedeck SS, Woch MA, Garcia-Lloret M, Chinthrajah RS. Phase 2, randomized multi oral immunotherapy with omalizumab 'real life' study. Allergy. 2022 Jun;77(6):1873-1884. doi: 10.1111/all.15217. Epub 2022 Jan 24.
- Sean N. Parker Center for Allergy and Asthma ResearchLink provided by the sponsor.
- Research Registry for the Sean N. Parker Center for Allergy and Asthma ResearchLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. pending
Related trials for Food Allergy
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Slow Multiallergen Oral Immunotherapy in Young Children
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Oral Immunotherapy for Children With Peanut Allergy
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RecruitingObservational study
Study of Oral Food Challenge Biomarkers (SAFER)
Allergy
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Efficacy of Tezepelumab in Peanut Oral Immunotherapy
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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.
Kari C Nadeau, MD PhD principal investigator
Stanford University
2 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 Food Flour Allergens in people with Food Allergy, run by Andrew Long, PharmD at 2 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 9 inclusion and 11 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 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 20 Sep 2019). 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?
Change in Allergen-specific Serum IgG4 and IgE (time frame: 18 weeks). 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 NCT03181009, which also lists 1 linked publication.
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 27 Apr 2026.