Food HypersensitivityNCT07027163
A Study About the Use of Omalizumab in the Treatment of Food Allergy and Anaphylaxis
An observational study of Food Hypersensitivity and Anaphylaxis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a retrospective, multi-center observational study conducted across four allergy departments in Europe (Berlin, Leipzig, Barcelona, and Basel). The study included patients with immunoglobulin E (IgE)-mediated food allergy who were treated with omalizumab, either as monotherapy or in combination with oral… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Food Hypersensitivity, Anaphylaxis
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- A confirmed history of food allergy, either with or without prior anaphylaxis.
- Treated with omalizumab, either as monotherapy or in combination with OIT.
Who cannot join
- None identified.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Omalizumab in the Treatment of Food Allergy and Anaphylaxis - A Multicenter Retrospective Analysis
This was a retrospective, multi-center observational study conducted across four allergy departments in Europe (Berlin, Leipzig, Barcelona, and Basel). The study included patients with immunoglobulin E (IgE)-mediated food allergy who were treated with omalizumab, either as monotherapy or in combination with oral immunotherapy (OIT) between 2002-2022.
- Conditions
- Food Hypersensitivity, Anaphylaxis
- Keywords
- Food Allergy, IgE-mediated Food Allergy
- Medical subject headings
- Food Hypersensitivity, Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab Cohort | Adult patients diagnosed with IgE-mediated food allergy who received omalizumab treatment between 2002 and 2022. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients by Response to Treatment
Patients were classified as treatment responders if an oral food challenge was negative, or a decrease in severity of food allergy during an oral food challenge was determined and no anaphylactic reactions occurred during treatment. Non-responders were those who experienced repetitive food anaphylactic reactions during treatment. Partial treatment responders were patients who experienced less than 1 food anaphylactic reaction despite undergoing treatment.
Measured: Months 3, 6, 12, and 24
Secondary outcomes (5)
Frequency of Accidental Reactions
Accidental reactions were those that occurred when a patient unknowingly ingested the food allergen.
Measured: Up to approximately 7 years
Change From Baseline in Allergen Threshold Levels
Allergen threshold was measured by oral food challenge test. The change in threshold level means the increase in the food dose that the patient was able to tolerate during the food challenge test.
Measured: From Baseline up to approximately 7 years
Change From Baseline in Severity of Anaphylactic Reactions
Change in severity of food allergy was either demonstrated by an oral food challenge or based on the clinical assessment by the investigator.
Measured: From Baseline up to approximately 7 years
Health-related Quality of Life (HRQoL) Based on Patient Reported Data as Measured by the EuroQol-5 Dimensions (EQ-5D) Questionnaire
The EQ-5D is a generic multidimensional measurement tool for describing HRQoL (EuroQol, 1999). The five domains of mobility, self-care ability, daily activities, pain/discomfort and anxiety/depression are considered. For each of the dimensions, the most appropriate answer from three given possibilities is selected (1=no problem, 2=moderate problem, 3=large problem). In addition, the patient marks the current state of health on a scale from 0 (worst conceivable state of health) to 100 (best conceivable state of health). HRQoL was measured if data was available.
Measured: Months 3, 6, 12, and 24
HRQoL Based on Patient Reported Data as Measured by the Food Allergy Quality of Life Questionnaire (FAQLQ)
FAQLQs are disease-specific questionnaires used to measure the impact of food allergy on HRQoL. The forms are completed by the patients themselves or by the parents of food-allergic children and teenagers. Questions are scored on a 7-point scale from 1 (no) to 7 (maximal) impairment on quality of life. HRQoL was measured if data was available.
Measured: Months 3, 6, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start1 Jun 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food HypersensitivityStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027163
- Sponsor's protocol ID
- CIGE025A2010
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Omalizumab in the Treatment of Food Allergy and Anaphylaxis - A Multicenter Retrospective Analysis
- ClinicalTrials.gov ID
- NCT07027163
- Acronym / sponsor ID
- CIGE025A2010
- Conditions
- Food Hypersensitivity, Anaphylaxis
- Keywords
- Food Allergy, IgE-mediated Food Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 18 Jun 2025 (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.
This was a retrospective, multi-center observational study conducted across four allergy departments in Europe (Berlin, Leipzig, Barcelona, and Basel). The study included patients with immunoglobulin E (IgE)-mediated food allergy who were treated with omalizumab, either as monotherapy or in combination with oral immunotherapy (OIT) between 2002-2022.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omalizumab Cohort | – | –Adult patients diagnosed with IgE-mediated food allergy who received omalizumab treatment between 2002 and 2022. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (2 listed)
- A confirmed history of food allergy, either with or without prior anaphylaxis.
- Treated with omalizumab, either as monotherapy or in combination with OIT.
Key exclusion criteria (1 listed)
- None identified.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Patients by Response to Treatment
Time frame: Months 3, 6, 12, and 24
Patients were classified as treatment responders if an oral food challenge was negative, or a decrease in severity of food allergy during an oral food challenge was determined and no anaphylactic reactions occurred during treatment. Non-responders were those who experienced repetitive food anaphylactic reactions during treatment. Partial treatment responders were patients who experienced less than 1 food anaphylactic reaction despite undergoing treatment.
5 secondary outcomes
Frequency of Accidental Reactions
Time frame: Up to approximately 7 years
Change From Baseline in Allergen Threshold Levels
Time frame: From Baseline up to approximately 7 years
Change From Baseline in Severity of Anaphylactic Reactions
Time frame: From Baseline up to approximately 7 years
Health-related Quality of Life (HRQoL) Based on Patient Reported Data as Measured by the EuroQol-5 Dimensions (EQ-5D) Questionnaire
Time frame: Months 3, 6, 12, and 24
HRQoL Based on Patient Reported Data as Measured by the Food Allergy Quality of Life Questionnaire (FAQLQ)
Time frame: Months 3, 6, 12, and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Hypersensitivity and Anaphylaxis, run by Novartis Pharmaceuticals 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 2 inclusion and 1 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 18 Jun 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Patients by Response to Treatment (time frame: Months 3, 6, 12, and 24). 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 18 Jun 2025.