Food AllergyPhase 4NCT06618963
Effect of Omalizumab in the Skin of Food Allergy Patients
A Phase 4 study testing Omalizumab Injection in people with Food Allergy and Food Allergy in Children, run by National Jewish Health at 1 site in United States.
Trial summary
The goal of this interventional study is to evaluate whether skin barrier abnormalities occur in subjects with a food allergy, as determined by positive oral food challenge (OFC). The main question it aims to answer is whether these skin barrier abnormalities can be reversed by omalizumab. Read more about this study
- Who is it for?
- Ages 1 year to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy, Food Allergy in Children
- What is being tested?
- Omalizumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to Dec 2026
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable.
- Male or female, 1-55 years old at screening.
- Total IgE level within 1 year of screening and weight at screening visit that together result in an eligible omalizumab dose according to the dosing table for FA (Appendix 8).
- Participant must meet the following clinical FA criteria: Food sensitization to peanut, hen's egg, a tree nut, sesame seed, cow's milk, wheat, or soy, within 1 year of screening AND experience dose-limiting, IgE mediated symptoms at or before 444mg of food protein cumulatively during screening OFC to peanut, hen's egg, a tree nut, sesame seed, cow's milk, wheat, or soy.
- If female of child-bearing potential, must have a negative urine or serum pregnancy test. If participating as a healthy control, self-report of pregnancy status is acceptable.
- For women of child-bearing potential, must agree to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods (barrier methods or oral, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy) during the treatment period and for 60 days after the last dose of study drug.
- Be willing to be trained on the proper use of an epinephrine autoinjector and be willing to always have epinephrine autoinjector immediately available for the duration of the study.
Who cannot join
- Inability or unwillingness of a participant and/or parent/legal guardian to give written informed consent and/or assent or comply with the study protocol.
- Clinically significant laboratory abnormalities at Screening.
- Sensitivity or suspected/known allergy to any ingredients (including excipients) of the active OFC material (other than the study food), or drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin).
- Poorly controlled AD at Screening, per the PI's discretion.
- Poorly controlled or severe asthma/wheezing at Screening
- History of severe anaphylaxis (defined as neurological compromise or requiring intubation) to a study food that is to be used for qualifying OFC in this study.
Show all 20Show fewer
- Treatment with oral, intramuscular (IM), or intravenous (IV) steroids of more than two days for an indication other than asthma/wheezing within 30 days of Screening.
- Currently receiving oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers (oral or topical).
- Past or current history of cancer, or currently being investigated for possible cancer.
- Previous adverse reaction to omalizumab.
- Past or current history of any immunotherapy to the OFC food (e.g., oral immunotherapy [OIT], sublingual immunotherapy [SLIT], or patch/epicutaneous immunotherapy [EPIT)] within 4 months of Screening.
- Treatment with monoclonal antibody therapy, such as omalizumab (Xolair®), dupilumab (Dupixent®), benralizumab (Fasenra™), mepolizumab (Nucala®), reslizumab (Cinqair®), or other immunomodulatory therapy within four months of Screening.
- Currently on "build-up phase" of inhalant allergen immunotherapy (i.e., has not reached maintenance dosing). Individuals tolerating maintenance allergen immunotherapy can be enrolled.
- Inability to discontinue antihistamines for the minimum wash-out periods required for SPTs or OFCs
- Current participation in another therapeutic or interventional clinical trial or participation within 90 days of Screening.
- Use of investigational drugs within 24 weeks of Screening.
- Pregnant or breastfeeding or intending to become pregnant during the study or within 60 days after the last dose of omalizumab.
- Have any skin disease other than AD that might compromise the stratum corneum barrier.
- History of serious life-threatening reaction to tape or adhesives.
- Healthy Control Participants (non-Food Allergy participants) may not have atopic dermatitis, autoimmune, or other conditions which, in the opinion of the PI, could confound the results of the study assessments or samples.
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
National Jewish Health
Denver, Colorado, 80206
Lead Coordinator, 303-398-1409, leungs@njhealth.org
About this study
The goal of this interventional study is to evaluate whether skin barrier abnormalities occur in subjects with a food allergy, as determined by positive oral food challenge (OFC). The main question it aims to answer is whether these skin barrier abnormalities can be reversed by omalizumab.
If there is a comparison group: Researchers will compare non-food allergic participants (who do not receive omalizumab) to see if they experience skin barrier abnormalities.
All food allergic participants will receive 4 months of Omalizumab treatment as well as two Oral Food Challenges. Participants will all undergo skin barrier assessments.
Read the detailed description
This is a phase IV open-label interventional pilot study of 30 patients enrolled at National Jewish Health to examine skin barrier function and response to OFC in patients with FA before and after 4 months of treatment with omalizumab. If enrollment is insufficient at National Jewish, Children's Hospital Colorado or another similarly qualified site will be used as a back-up site. Efficacy assessment will be assessed by the ability of Omalizumab to reduce clinical response to OFC. The safety of omalizumab will be concomitantly recorded. Specifically, we will:
- Examine TEWL, STS lipidomics, metabolomics, cytokines, and proteomics in 30 patients with a history of IgE-mediated reaction to 1 or more foods assessed by sensitization food extracts using skin prick tests, serum IgE to specific foods and/or relevant component proteins, and an IgE-mediated clinical reaction to a food on OFC.
- Confirm the diagnosis of IgE-mediated FA in all patients with a positive OFC.
- Treat all 30 patients with omalizumab for 4 months
- Repeat OFC after 4 months of omalizumab therapy.
- To analyze TEWL, STS Lipidomics, metabolomics, proteomics, and cytokines in all 30 patients who were treated with omalizumab and completed the end of study OFC.
Sample size will be 30 completed subjects. Enrollment will occur over the course of 16 months, with 2-4 participants enrolling each month. Up to ten healthy control subjects will also be enrolled for skin tape strip analysis and TEWL as a comparator group to the FA group.
All participants will have an initial screening visit where their clinical history of having an IgE-mediated reaction to specified food(s) will be elucidated, along with review of relevant skin prick test (SPT), food-specific IgE values, and Total IgE. If these values were not obtained within the last 12 months, SPT, sIgE, and/or Total IgE will be performed at screening. All food-allergic participants will undergo an open Screening OFC to one of their food allergens. For continuation in the study, the participant must experience dose-limiting symptoms consistent with an IgE-mediated reaction, at or before 444mg of food protein cumulatively. If they have a negative OFC, additional screening OFCs may be performed to any eligible food. STS and TEWL measurements will be performed prior to the first dose, as well as before the second and third doses. If/when the participant has dose-limiting symptoms, STS and TEWL will be stopped immediately.
All food-allergic participants will receive omalizumab for 4 months. All injections will be administered by a research nurse on the clinical research unit. At the midway point of the study (2 months after the first omalizumab injection), the participant will have STS and TEWL measurements performed.
After 4 months of omalizumab administration, an end of study OFC will be performed to the same food that was positive at the screening OFC to assess treatment effect, along with analysis of the STS and TEWL.
- Conditions
- Food Allergy, Food Allergy in Children
- Being tested
- Omalizumab Injection
- Keywords
- Food Allergy
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omalizumab InjectionDrug
Also called Xolair
Omalizumab is a monoclonal antibody FDA-approved for treatment of food allergy.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Food Allergy | Active comparator | This group will receive 4 months of Omalizumab treatment, and undergo regular skin barrier assessments. Receives: Drug: Omalizumab Injection |
| Participants without Food Allergy | No intervention | This group will undergo skin barrier assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipidomic analysis
Lipid measurements from Skin Tape Strips (STS), as detected at respective m/z from mass spectrometry
Measured: 5 months
Metabolomic analysis
Metabolomics from STS, evaluated as a relative signal proportion of metabolites against the sum of all signals in the samples
Measured: 5 months
Proteomic analysis
Proteomics from STS, comparison of global protein expression before vs after omalizumab treatment
Measured: 5 months
Cytokine analysis
Cytokine levels from STS measured using preconfigured multiplex assays normalized to the total protein in each sample. Cytokines that will be measured: IL-1a, IL-1b, IL-18, IL-6, IL-8, TARC, MDC, TSLP, IL-33, IL-4, IL-13, IL-22, IL-31, eotaxins, IL-10, IL-17A/F, IL-17C, IL-12p70, IL-23, IP-10
Measured: 5 months
Measurement of Transepidermal Water Loss
Transepidermal Water Loss (TEWL) is measured by the loss through the skin of grams of water per square meter per hour (g/m^2/h).
Measured: 5 months
Secondary outcomes (5)
Measurement of Transepidermal Water Loss in non Food-Allergic Subjects
Transepidermal Water Loss (TEWL), grams water per square meter per hour (g/m^2/h)
Measured: 5 months
Lipidomic analysis in non Food-Allergic participants
Lipid measurements from Skin Tape Strips (STS), as detected at respective m/z from mass spectrometry
Measured: 5 months
Metabolomic analysis in non Food-Allergic Participants
Metabolomics from STS, evaluated as a relative signal proportion of metabolites against the sum of all signals in the samples
Measured: 5 months
Proteomic analysis in non Food-Allergic Participants
Proteomics from STS, baseline expression levels of proteins found in non-allergic skin tapes.
Measured: 5 months
Cytokine analysis
Cytokine levels from STS from non-Food Allergic participants, measured using preconfigured multiplex assays normalized to the total protein in each sample. Cytokines that will be measured: IL-1a, IL-1b, IL-18, IL-6, IL-8, TARC, MDC, TSLP, IL-33, IL-4, IL-13, IL-22, IL-31, eotaxins, IL-10, IL-17A/F, IL-17C, IL-12p70, IL-23, IP-10
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Oct 2024
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (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.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 30 subjects with food allergy 10 subjects without food allergy
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- Roche-Genentech
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618963
- Sponsor's protocol ID
- RO-IIS-1660
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Omalizumab in the Skin of Food Allergy Patients
- ClinicalTrials.gov ID
- NCT06618963
- Acronym / sponsor ID
- RO-IIS-1660
- Conditions
- Food Allergy, Food Allergy in Children
- Keywords
- Food Allergy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- Roche-Genentech
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Oct 2024 (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 interventional study is to evaluate whether skin barrier abnormalities occur in subjects with a food allergy, as determined by positive oral food challenge (OFC). The main question it aims to answer is whether these skin barrier abnormalities can be reversed by omalizumab.
If there is a comparison group: Researchers will compare non-food allergic participants (who do not receive omalizumab) to see if they experience skin barrier abnormalities.
All food allergic participants will receive 4 months of Omalizumab treatment as well as two Oral Food Challenges. Participants will all undergo skin barrier assessments.
Detailed description
This is a phase IV open-label interventional pilot study of 30 patients enrolled at National Jewish Health to examine skin barrier function and response to OFC in patients with FA before and after 4 months of treatment with omalizumab. If enrollment is insufficient at National Jewish, Children's Hospital Colorado or another similarly qualified site will be used as a back-up site. Efficacy assessment will be assessed by the ability of Omalizumab to reduce clinical response to OFC. The safety of omalizumab will be concomitantly recorded. Specifically, we will:
- Examine TEWL, STS lipidomics, metabolomics, cytokines, and proteomics in 30 patients with a history of IgE-mediated reaction to 1 or more foods assessed by sensitization food extracts using skin prick tests, serum IgE to specific foods and/or relevant component proteins, and an IgE-mediated clinical reaction to a food on OFC.
- Confirm the diagnosis of IgE-mediated FA in all patients with a positive OFC.
- Treat all 30 patients with omalizumab for 4 months
- Repeat OFC after 4 months of omalizumab therapy.
- To analyze TEWL, STS Lipidomics, metabolomics, proteomics, and cytokines in all 30 patients who were treated with omalizumab and completed the end of study OFC.
Sample size will be 30 completed subjects. Enrollment will occur over the course of 16 months, with 2-4 participants enrolling each month. Up to ten healthy control subjects will also be enrolled for skin tape strip analysis and TEWL as a comparator group to the FA group.
All participants will have an initial screening visit where their clinical history of having an IgE-mediated reaction to specified food(s) will be elucidated, along with review of relevant skin prick test (SPT), food-specific IgE values, and Total IgE. If these values were not obtained within the last 12 months, SPT, sIgE, and/or Total IgE will be performed at screening. All food-allergic participants will undergo an open Screening OFC to one of their food allergens. For continuation in the study, the participant must experience dose-limiting symptoms consistent with an IgE-mediated reaction, at or before 444mg of food protein cumulatively. If they have a negative OFC, additional screening OFCs may be performed to any eligible food. STS and TEWL measurements will be performed prior to the first dose, as well as before the second and third doses. If/when the participant has dose-limiting symptoms, STS and TEWL will be stopped immediately.
All food-allergic participants will receive omalizumab for 4 months. All injections will be administered by a research nurse on the clinical research unit. At the midway point of the study (2 months after the first omalizumab injection), the participant will have STS and TEWL measurements performed.
After 4 months of omalizumab administration, an end of study OFC will be performed to the same food that was positive at the screening OFC to assess treatment effect, along with analysis of the STS and TEWL.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 30 subjects with food allergy 10 subjects without food allergy
| Arm | Type | Receives |
|---|---|---|
| Participants with Food Allergy | Active comparator | Drug: Omalizumab InjectionThis group will receive 4 months of Omalizumab treatment, and undergo regular skin barrier assessments. |
| Participants without Food Allergy | No intervention | –This group will undergo skin barrier assessment. |
Who may qualify
- Ages
- 1 year to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable.
- Male or female, 1-55 years old at screening.
- Total IgE level within 1 year of screening and weight at screening visit that together result in an eligible omalizumab dose according to the dosing table for FA (Appendix 8).
- Participant must meet the following clinical FA criteria: Food sensitization to peanut, hen's egg, a tree nut, sesame seed, cow's milk, wheat, or soy, within 1 year of screening AND experience dose-limiting, IgE mediated symptoms at or before 444mg of food protein cumulatively during screening OFC to peanut, hen's egg, a tree nut, sesame seed, cow's milk, wheat, or soy.
- If female of child-bearing potential, must have a negative urine or serum pregnancy test. If participating as a healthy control, self-report of pregnancy status is acceptable.
Key exclusion criteria (20 listed)
- Inability or unwillingness of a participant and/or parent/legal guardian to give written informed consent and/or assent or comply with the study protocol.
- Clinically significant laboratory abnormalities at Screening.
- Sensitivity or suspected/known allergy to any ingredients (including excipients) of the active OFC material (other than the study food), or drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin).
- Poorly controlled AD at Screening, per the PI's discretion.
- Poorly controlled or severe asthma/wheezing at Screening
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 |
|---|---|---|
| Omalizumab InjectionAlso: XolairOmalizumab is a monoclonal antibody FDA-approved for treatment of food allergy. | Drug | Participants with Food Allergy |
Primary outcome
Lipidomic analysis
Time frame: 5 months
Lipid measurements from Skin Tape Strips (STS), as detected at respective m/z from mass spectrometry
Metabolomic analysis
Time frame: 5 months
Metabolomics from STS, evaluated as a relative signal proportion of metabolites against the sum of all signals in the samples
Proteomic analysis
Time frame: 5 months
Proteomics from STS, comparison of global protein expression before vs after omalizumab treatment
Cytokine analysis
Time frame: 5 months
Cytokine levels from STS measured using preconfigured multiplex assays normalized to the total protein in each sample. Cytokines that will be measured: IL-1a, IL-1b, IL-18, IL-6, IL-8, TARC, MDC, TSLP, IL-33, IL-4, IL-13, IL-22, IL-31, eotaxins, IL-10, IL-17A/F, IL-17C, IL-12p70, IL-23, IP-10
Measurement of Transepidermal Water Loss
Time frame: 5 months
Transepidermal Water Loss (TEWL) is measured by the loss through the skin of grams of water per square meter per hour (g/m^2/h).
5 secondary outcomes
Measurement of Transepidermal Water Loss in non Food-Allergic Subjects
Time frame: 5 months
Lipidomic analysis in non Food-Allergic participants
Time frame: 5 months
Metabolomic analysis in non Food-Allergic Participants
Time frame: 5 months
Proteomic analysis in non Food-Allergic Participants
Time frame: 5 months
Cytokine analysis
Time frame: 5 months
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 2 May 2025.
- 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.
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 Injection in people with Food Allergy and Food Allergy in Children, run by National Jewish Health 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 7 inclusion and 20 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 2 May 2025. 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 Lead Coordinator (3033981409, leungs@njhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipidomic analysis (time frame: 5 months). The study lists 5 primary outcomes in all. 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 2 May 2025.