Food AllergyPhase 4NCT07845552
Oral Food Challenge After One to Two Doses of Omalizumab Treatment for Food Allergy
A Phase 4 study testing Omalizumab in people with Food Allergy, run by Johns Hopkins University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn how quickly omalizumab begins to work in people with food allergy. The main question it aims to answer is: Does omalizumab begin to work as early as 2 to 4 weeks after after starting treatment in people with food allergy? Researchers will compare each participant's food… Read more about this study
- Who is it for?
- Ages 1 year to 30 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- Omalizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2026to Oct 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 1 year to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 1 to 30 years.
- Patients with diagnosed food allergy to at least one of the following foods (milk, egg, wheat, peanut, cashew, or walnut) who were prescribed omalizumab for food allergy in the clinical setting at the Johns Hopkins pediatric or adult allergy clinic.
- Positive food-specific IgE (≥2.0 kUA/L) to the relevant food OR a positive skin-prick test with a wheal ≥4 mm larger than the saline control.
- Positive open oral food challenge at baseline screening evaluation to the relevant food with dose-limiting symptoms at a single dose of ≤1000 mg (cumulative dose of ≤2043 mg) prior to starting omalizumab (using incremental doses of 3, 10, 30, 100, 300, 600, 1000 mg).
- Prior authorization from the patient's insurance provider for clinical use of omalizumab.
Who cannot join
- Clinically significant laboratory abnormalities in the past 6 months.
- Sensitivity or suspected/known allergy to any ingredients (including excipients) of omalizumab
- Poorly controlled or severe asthma/wheezing at screening
- History of severe anaphylaxis to the participant-specific food that will be used in this study, defined as neurological compromise or requiring intubation.
- Currently receiving oral, intramuscular (IM), or intravenous (IV) corticosteroids, tricyclic antidepressants, or β-blockers.
- Past or current history of cancer, or currently being investigated for possible cancer.
Show all 11Show fewer
- Past or current history of any food immunotherapy, such as oral immunotherapy (OIT), sublingual immunotherapy (SLIT), epicutaneous immunotherapy (EPIT) within 6 months of screening.
- Treatment with monoclonal antibody therapy, such as omalizumab, dupilumab, benralizumab, mepolizumab, reslizumab, tezepelumab, or other immunomodulatory therapy within 6 months of screening.
- Inability to discontinue antihistamines for minimum wash-out periods required for skin-prick test or oral food challenge.
- Pregnant or breastfeeding, or intending to become pregnant during the study
- Evidence of clinically significant chronic disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Kim Mudd, 410-955-5883, kmudd2@jhmi.edu
Robert Wood, MD, 410-955-5883, rwood@jhmi.edu
About this study
The goal of this clinical trial is to learn how quickly omalizumab begins to work in people with food allergy. The main question it aims to answer is:
- Does omalizumab begin to work as early as 2 to 4 weeks after after starting treatment in people with food allergy?
Read more
Researchers will compare each participant's food challenge results at baseline before starting omalizumab, 2 to 4 weeks after starting omalizumab, and 4 to 6 months after starting omalizumab treatment.
Participants will:
- Have a baseline food challenge before starting omalizumab.
- Start omalizumab treatment as prescribed by the participant's doctor as part of regular clinical care.
- Have food challenges 2 to 4 weeks after starting omalizumab and again 4 to 6 months after starting omalizumab.
- Have skin prick testing and blood tests at study visits.
- Conditions
- Food Allergy
- Being tested
- Omalizumab
- Keywords
- food allergy, omalizumab, oral food challenge
- 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
Prior to starting omalizumab, participants will undergo a baseline oral food challenge. Participants will then initiate omalizumab treatment as prescribed by their doctor as part of routine clinical care. After 2 to 4 weeks of treatment (following one to two doses of omalizumab), participants will undergo a first post-treatment oral food challenge to assess treatment response. After 4 to 6 months of omalizumab treatment, participants will undergo a second post-treatment oral food challenge. The study will conclude following the second post-treatment oral food challenge.
| Study group | Role | What they receive |
|---|---|---|
| omalizumab | Experimental | Omalizumab is approved by the FDA for the treatment of food allergy in patients aged 1 year and older. Omalizumab is administered as a subcutaneous injection at doses ranging from 75 mg to 600 mg every 2 or 4 weeks.
Omalizumab treatment is not provided as part of this study. Participants will receive omalizumab treatment as part of their routine care for food allergy as prescribed by their doctor in the clinical setting. Receives: Drug: Omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving pre-specified thresholds without dose-limiting symptoms during first post-treatment oral food challenge.
The pre-specified thresholds for response is defined as the ability to consume at least two more incremental doses of food protein during post-treatment oral food challenge (using incremental doses of 3, 10, 30, 100, 300, 600, 1000, 2000, 2000, and 2000 mg), than during the baseline oral food challenge. First post-treatment oral food challenge conducted between ≥14 and ≤35 days after starting omalizumab (after one or two doses of omalizumab depending on whether the participant is receiving omalizumab every 2 or 4 weeks).
Measured: Between ≥14 and ≤35 days after starting omalizumab
Secondary outcomes (2)
The absolute change in oral food challenge threshold between baseline and the first post-treatment oral food challenge.
Baseline oral food challenge conducted prior to starting omalizumab. First post-treatment oral food challenge conducted at ≥14 and ≤35 days after starting of omalizumab.
Measured: Baseline, between ≥14 and ≤35 days after starting omalizumab
The absolute change in oral food challenge threshold between the first and second post-treatment oral food challenges.
First post-treatment oral food challenge conducted at ≥14 and ≤35 days after starting of omalizumab. Second post-treatment oral food challenge conducted between 4 to 6 months after starting omalizumab.
Measured: between ≥14 and ≤35 days after starting omalizumab, 4-6 months after starting omalizumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start19 Oct 2026
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Omalizumab treatment is prescribed by the participant's doctor as part of routine clinical care and is not provided by this study.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Wood, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845552
- Sponsor's protocol ID
- IRB00570914
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Food Challenge After One to Two Doses of Omalizumab Treatment for Food Allergy
- ClinicalTrials.gov ID
- NCT07845552
- Acronym / sponsor ID
- IRB00570914
- Conditions
- Food Allergy
- Keywords
- food allergy, omalizumab, oral food challenge
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 19 Oct 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn how quickly omalizumab begins to work in people with food allergy. The main question it aims to answer is:
- Does omalizumab begin to work as early as 2 to 4 weeks after after starting treatment in people with food allergy?
Researchers will compare each participant's food challenge results at baseline before starting omalizumab, 2 to 4 weeks after starting omalizumab, and 4 to 6 months after starting omalizumab treatment.
Participants will:
- Have a baseline food challenge before starting omalizumab.
- Start omalizumab treatment as prescribed by the participant's doctor as part of regular clinical care.
- Have food challenges 2 to 4 weeks after starting omalizumab and again 4 to 6 months after starting omalizumab.
- Have skin prick testing and blood tests at study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Omalizumab treatment is prescribed by the participant's doctor as part of routine clinical care and is not provided by this study.
| Arm | Type | Receives |
|---|---|---|
| omalizumab | Experimental | Drug: OmalizumabOmalizumab is approved by the FDA for the treatment of food allergy in patients aged 1 year and older. Omalizumab is administered as a subcutaneous injection at doses ranging from 75 mg to 600 mg every 2 or 4 weeks. Omalizumab treatment is not provided as part of this study. Participants will receive omalizumab treatment as part of their routine care for food allergy as prescribed by their doctor in the clinical setting. |
Who may qualify
- Ages
- 1 year to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 1 to 30 years.
- Patients with diagnosed food allergy to at least one of the following foods (milk, egg, wheat, peanut, cashew, or walnut) who were prescribed omalizumab for food allergy in the clinical setting at the Johns Hopkins pediatric or adult allergy clinic.
- Positive food-specific IgE (≥2.0 kUA/L) to the relevant food OR a positive skin-prick test with a wheal ≥4 mm larger than the saline control.
- Positive open oral food challenge at baseline screening evaluation to the relevant food with dose-limiting symptoms at a single dose of ≤1000 mg (cumulative dose of ≤2043 mg) prior to starting omalizumab (using incremental doses of 3, 10, 30, 100, 300, 600, 1000 mg).
- Prior authorization from the patient's insurance provider for clinical use of omalizumab.
Key exclusion criteria (11 listed)
- Clinically significant laboratory abnormalities in the past 6 months.
- Sensitivity or suspected/known allergy to any ingredients (including excipients) of omalizumab
- Poorly controlled or severe asthma/wheezing at screening
- History of severe anaphylaxis to the participant-specific food that will be used in this study, defined as neurological compromise or requiring intubation.
- Currently receiving oral, intramuscular (IM), or intravenous (IV) corticosteroids, tricyclic antidepressants, or β-blockers.
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 |
|---|---|---|
| OmalizumabPrior to starting omalizumab, participants will undergo a baseline oral food challenge. Participants will then initiate omalizumab treatment as prescribed by their doctor as part of routine clinical care. After 2 to 4 weeks of treatment (following one to two doses of omalizumab), participants will undergo a first post-treatment oral food challenge to assess treatment response. After 4 to 6 months of omalizumab treatment, participants will undergo a second post-treatment oral food challenge. The study will conclude following the second post-treatment oral food challenge. | Drug | omalizumab |
Primary outcome
Proportion of participants achieving pre-specified thresholds without dose-limiting symptoms during first post-treatment oral food challenge.
Time frame: Between ≥14 and ≤35 days after starting omalizumab
The pre-specified thresholds for response is defined as the ability to consume at least two more incremental doses of food protein during post-treatment oral food challenge (using incremental doses of 3, 10, 30, 100, 300, 600, 1000, 2000, 2000, and 2000 mg), than during the baseline oral food challenge. First post-treatment oral food challenge conducted between ≥14 and ≤35 days after starting omalizumab (after one or two doses of omalizumab depending on whether the participant is receiving omalizumab every 2 or 4 weeks).
2 secondary outcomes
The absolute change in oral food challenge threshold between baseline and the first post-treatment oral food challenge.
Time frame: Baseline, between ≥14 and ≤35 days after starting omalizumab
The absolute change in oral food challenge threshold between the first and second post-treatment oral food challenges.
Time frame: between ≥14 and ≤35 days after starting omalizumab, 4-6 months after starting omalizumab
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data.
Related trials for Food Allergy
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Not yet recruitingObservational study
Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
Hypersensitivity, Food, Legumes Allergy
Not yet recruiting
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
Allergy, Food Allergies
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
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.
Robert Wood, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omalizumab in people with Food Allergy, run by Johns Hopkins University at 1 site 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 5 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Tseng, MD (410-955-5883, htseng9@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving pre-specified thresholds without dose-limiting symptoms during first post-treatment oral food challenge. (time frame: Between ≥14 and ≤35 days after starting omalizumab). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2026.