Food AllergyPhase 4NCT03964051
Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana).
A Phase 4 study testing Omalizumab Injection in people with Food Allergy, run by Carsten Bindslev-Jensen at 1 site in Denmark.
Trial summary
Anaphylaxis elicited by accidental intake of the offending food constitutes a major health risk to the food allergic patient. Current advice for the food allergic patient is to avoid the offending food allergen and to carry an epinephrine autoinjector. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Food Allergy
- 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
- 7 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2019to 21 Dec 2020
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18 - 70 years with verified allergy to a food allergen, where validated methods for determination of specific IgE to the food and to the major allergens (Component Resolved Diagnostics) are available. The foods include, but will not be confined to milk, egg, peanut, hazelnut, sesame, wheat, cod and shrimp. Patients with/without elevated levels of total IgE (> 1000 kIU/l) will be included. Minimum level of specific IgE to the major allergen component in the food in question will be 10 kIU/l. No control group will be included.
Who cannot join
- Ischemic heart disease or other significant co-morbidity (e.g. uncontrolled asthma) that might compromise the patient's safety or study outcomes.
- Infection on the day of study
- Pregnancy or nursing. Women of childbearing potential have to use safe contraception (intrauterine device or hormonal contraception (birth control pill, implant, transdermal patch, vaginal ring or depot injection)). Safe contraception has to be used during the whole trial period and half a year after the last dose of the trial medicine has been taken. It is accepted, if the female patient is permanently sterile or infertile, if her sole partner is permanently sterile or if they use both condom and diaphragm. The definition of sterile or infertile is surgically sterilized (vasectomy/bilateral salpingectomy, hysterectomy and/or bilateral ovariectomy) or post menopause defined as a non-menstrual period of at least 12 months before inclusion in the trial.
- Ongoing treatment with antihistamine or drugs with antihistaminic properties that cannot be paused three days prior to the tests
- Ongoing treatment with β-blockers that cannot be paused one day prior to the tests
- Ongoing treatment with oral glucocorticoids (>10 mg daily)
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- Alcohol abuse, abuse of opioids or other drugs
- Occurrence of unexpected side effects
- Patients who are not supposed to be able to meet the requirements in the protocol
- Patients who are physically or mentally unable to consent
- Patients who have reduced liver function or kidney function
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Odense Research Center for Anaphylaxis, Allergy Center
Odense C, Funen, 5000
About this study
Anaphylaxis elicited by accidental intake of the offending food constitutes a major health risk to the food allergic patient. Current advice for the food allergic patient is to avoid the offending food allergen and to carry an epinephrine autoinjector. However, novel treatments altering the clinical reactivity to the offending food thereby diminishing the risk of anaphylaxis are much needed. A correlation between the level of specific IgE in serum towards the offending food and the clinical sensitivity of the patient has been suggested. The clinical threshold for a food allergic reaction to occur is therefore hypothesized to increase by reducing the level of specific IgE to the relevant food allergen.
Therapy with Omalizumab has proven efficacious in lowering the level of IgE in serum but a high pre-treatment level of total IgE in serum potentially hampers the efficacy in a number of patients, as seen especially in patients with concomitant atopic dermatitis. The aim of this study is to investigate if the combination of initial IgE specific immunoadsorption combined with subsequent treatment with Omalizumab will increase the clinical threshold to the culprit food and thus prevent medical emergencies (anaphylaxis) in patients with severe food allergy.
Read the detailed description
10 patients with a proven food allergy will be submitted to the combined effort of IgE specific (selective) immunoadsorption and subsequent treatment with Omalizumab.
An Oral Food Challenge (OFC) will be performed before, during and after the above mentioned treatments according to international guidelines with administration of increasing doses (3, 10, 30, 100, 300, 1000 and 3000 mg of protein) of the incriminated food at one hour intervals, until objective signs of an allergic reaction in the patient occur. The cumulated dose eaten before this reaction is defined as the threshold (Tr).
The patient's threshold value (mg protein) before therapy (Tr0) will be determined by OFC immediately before three cycles of immunoadsorption on three consecutive days are performed. This repeated procedure will expectedly reduce the serum level of IgE (total as well as specific) by a factor of at least 10. Immediately after the last day of immunoadsorption, a second OFC for determination of threshold (TrP) will be performed and compared to Tr0, in order to determine the efficacy of the immunoadsorption.
Immediately after finalization of the second OFC, treatment with Omalizumab 300 mg s.c. injection will be initiated and repeated every 2 weeks until 12 weeks of treatment has been reached. The administration, the dose and dose interval is the recommended dosage as to the SPC (Summary of Product Characteristics). Treatment with Omalizumab will expectedly reduce the level of serum IgE (total as well as specific) by a factor of 2-4. The day following the final administration of Omalizumab, a third OFC for determination of threshold (TrX) will be performed and followed by a fourth OFC for determination of threshold (TrW) four weeks later. These thresholds will be compared to Tr0 and TrP to determine the combined efficacy of immunoadsorption and therapy with Omalizumab during therapy and after cessation of therapy.
Skin Prick Tests (SPTs), serum levels of total (t-IgE) and specific IgE (s-IgE) as well as relevant component resolved diagnostics (all in kIU/L) and Basophil Histamine Release (BaHR) (ng/mL) for relevant food allergens will be determined immediately before and after immunoadsorption, before challenges and before administration of Omalizumab.
Provided that 80 % of the patients will respond to immunoadsorption and therapy with Omalizumab (i.e. a comparison between Tr0 and TrX) with at least a two-step increase in threshold, a number of 10 included patients will result in a statistical significance for difference between the two parameters of 0.0047, if the remaining two patients do not change their threshold values. If, additionally one patient decreases threshold (i.e. 7 positive, 2 unchanged and 1 negative), the value will still be statistically significant (p=0.0142) using the Wilcoxon signed-rank test. The specified number of patients have to complete the study to ensure the results.
GCP-monitoring is performed by the local GCP-unit at Odense University Hospital.
- Conditions
- Food Allergy
- Being tested
- Omalizumab Injection
- Keywords
- Omalizumab, Xolair, Anaphylaxis
- 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.
Omalizumab InjectionDrug
Also called Xolair 300 mg
Omalizumab 300 mg for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab 300 mg for s.c.injection | Experimental | Omalizumab 300 mg steril solution in prefilled syringes are administrated every 2. week for 12 weeks Receives: Drug: Omalizumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in food challenge threshold (as measured in amount of food protein in milligrams tolerated by oral challenge)
As described open food challenges will be performed according to international guidelines (1) at specified time points and thresholds for a clinical objective reaction as measured in milligrams food protein before (Tr0) and after (TrP) the initial immunoadsorption and then during (TrX) and after cessation (TrW) of treatment with Omalizumab. Challenge thresholds at Tr0, TrP, TrX and TrW will be reported for each patient and compared. Since the study is non-randomized and uncontrolled the individual patient will serve as his/her own control. A 2-step change in threshold will be considered significant.
Measured: 18 weeks
Secondary outcomes (1)
Change in SPT size (mm) and levels of s-IgE, t-IgE and BaHR
At the specified time points (Tr0, TrP, TrX and TrW) SPT and measurement of specific IgE and component resolved diagnostics (for relevant allergens for the individual patient), total IgE and BaHR will be measured and compared. Since the study is non-randomized and uncontrolled the individual patient will serve as his/her own control. The immunological changes will be correlated to the corresponding thresholds (the primary outcome). An inverse correlation is expected (reduced immunological response expected to correlate with increased thresholds).
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 posted28 May 2019
- Study start1 Jul 2019
- Primary completion21 Dec 2020
- Study completion21 Dec 2020
Why it stopped: Finished
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 10 patients with severe food allergy will receive subcutaneous injections of Omalizumab 300 mg every 2 week for 12 weeks.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carsten Bindslev-Jensen
- Sponsor type
- University, hospital or other
- Collaborators
- Miltenyi Biomedicine GmbH
- Responsible party
- Sponsor-investigator, Carsten Bindslev-Jensen, Odense University Hospital
- Investigators
- Carsten Bindslev-Jensen, ProfDrMedPhd, Study director, Odense Research Center for AnaphylaxisCharlotte G. Moertz, ProfMDPhd, Study chair, Odense Research Center for Anaphylaxis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964051
- Sponsor's protocol ID
- 2017-003627-30
- Other IDs
- 2017
- Status last verified
- Dec 2023
- First submitted
- 16 May 2019
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bindslev-Jensen C, Ballmer-Weber BK, Bengtsson U, Blanco C, Ebner C, Hourihane J, Knulst AC, Moneret-Vautrin DA, Nekam K, Niggemann B, Osterballe M, Ortolani C, Ring J, Schnopp C, Werfel T; European Academy of Allergology and Clinical Immunology. Standardization of food challenges in patients with immediate reactions to foods--position paper from the European Academy of Allergology and Clinical Immunology. Allergy. 2004 Jul;59(7):690-7. doi: 10.1111/j.1398-9995.2004.00466.x. No abstract available.
PubMed 15180754
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana).
- ClinicalTrials.gov ID
- NCT03964051
- Acronym / sponsor ID
- 2017-003627-30
- Conditions
- Food Allergy
- Keywords
- Omalizumab, Xolair, Anaphylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Finished
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Carsten Bindslev-JensenUniversity, hospital or other
- Collaborators
- Miltenyi Biomedicine GmbH
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 28 May 2019 (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.
Anaphylaxis elicited by accidental intake of the offending food constitutes a major health risk to the food allergic patient. Current advice for the food allergic patient is to avoid the offending food allergen and to carry an epinephrine autoinjector. However, novel treatments altering the clinical reactivity to the offending food thereby diminishing the risk of anaphylaxis are much needed. A correlation between the level of specific IgE in serum towards the offending food and the clinical sensitivity of the patient has been suggested. The clinical threshold for a food allergic reaction to occur is therefore hypothesized to increase by reducing the level of specific IgE to the relevant food allergen.
Therapy with Omalizumab has proven efficacious in lowering the level of IgE in serum but a high pre-treatment level of total IgE in serum potentially hampers the efficacy in a number of patients, as seen especially in patients with concomitant atopic dermatitis. The aim of this study is to investigate if the combination of initial IgE specific immunoadsorption combined with subsequent treatment with Omalizumab will increase the clinical threshold to the culprit food and thus prevent medical emergencies (anaphylaxis) in patients with severe food allergy.
Detailed description
10 patients with a proven food allergy will be submitted to the combined effort of IgE specific (selective) immunoadsorption and subsequent treatment with Omalizumab.
An Oral Food Challenge (OFC) will be performed before, during and after the above mentioned treatments according to international guidelines with administration of increasing doses (3, 10, 30, 100, 300, 1000 and 3000 mg of protein) of the incriminated food at one hour intervals, until objective signs of an allergic reaction in the patient occur. The cumulated dose eaten before this reaction is defined as the threshold (Tr).
The patient's threshold value (mg protein) before therapy (Tr0) will be determined by OFC immediately before three cycles of immunoadsorption on three consecutive days are performed. This repeated procedure will expectedly reduce the serum level of IgE (total as well as specific) by a factor of at least 10. Immediately after the last day of immunoadsorption, a second OFC for determination of threshold (TrP) will be performed and compared to Tr0, in order to determine the efficacy of the immunoadsorption.
Immediately after finalization of the second OFC, treatment with Omalizumab 300 mg s.c. injection will be initiated and repeated every 2 weeks until 12 weeks of treatment has been reached. The administration, the dose and dose interval is the recommended dosage as to the SPC (Summary of Product Characteristics). Treatment with Omalizumab will expectedly reduce the level of serum IgE (total as well as specific) by a factor of 2-4. The day following the final administration of Omalizumab, a third OFC for determination of threshold (TrX) will be performed and followed by a fourth OFC for determination of threshold (TrW) four weeks later. These thresholds will be compared to Tr0 and TrP to determine the combined efficacy of immunoadsorption and therapy with Omalizumab during therapy and after cessation of therapy.
Skin Prick Tests (SPTs), serum levels of total (t-IgE) and specific IgE (s-IgE) as well as relevant component resolved diagnostics (all in kIU/L) and Basophil Histamine Release (BaHR) (ng/mL) for relevant food allergens will be determined immediately before and after immunoadsorption, before challenges and before administration of Omalizumab.
Provided that 80 % of the patients will respond to immunoadsorption and therapy with Omalizumab (i.e. a comparison between Tr0 and TrX) with at least a two-step increase in threshold, a number of 10 included patients will result in a statistical significance for difference between the two parameters of 0.0047, if the remaining two patients do not change their threshold values. If, additionally one patient decreases threshold (i.e. 7 positive, 2 unchanged and 1 negative), the value will still be statistically significant (p=0.0142) using the Wilcoxon signed-rank test. The specified number of patients have to complete the study to ensure the results.
GCP-monitoring is performed by the local GCP-unit at Odense University Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 10 patients with severe food allergy will receive subcutaneous injections of Omalizumab 300 mg every 2 week for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Omalizumab 300 mg for s.c.injection | Experimental | Drug: Omalizumab InjectionOmalizumab 300 mg steril solution in prefilled syringes are administrated every 2. week for 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals aged 18 - 70 years with verified allergy to a food allergen, where validated methods for determination of specific IgE to the food and to the major allergens (Component Resolved Diagnostics) are available. The foods include, but will not be confined to milk, egg, peanut, hazelnut, sesame, wheat, cod and shrimp. Patients with/without elevated levels of total IgE (> 1000 kIU/l) will be included. Minimum level of specific IgE to the major allergen component in the food in question will be 10 kIU/l. No control group will be included.
Key exclusion criteria (11 listed)
- Ischemic heart disease or other significant co-morbidity (e.g. uncontrolled asthma) that might compromise the patient's safety or study outcomes.
- Infection on the day of study
- Pregnancy or nursing. Women of childbearing potential have to use safe contraception (intrauterine device or hormonal contraception (birth control pill, implant, transdermal patch, vaginal ring or depot injection)). Safe contraception has to be used during the whole trial period and half a year after the last dose of the trial medicine has been taken. It is accepted, if the female patient is permanently sterile or infertile, if her sole partner is permanently sterile or if they use both condom and diaphragm. The definition of sterile or infertile is surgically sterilized (vasectomy/bilateral salpingectomy, hysterectomy and/or bilateral ovariectomy) or post menopause defined as a non-menstrual period of at least 12 months before inclusion in the trial.
- Ongoing treatment with antihistamine or drugs with antihistaminic properties that cannot be paused three days prior to the tests
- Ongoing treatment with β-blockers that cannot be paused one day prior to the tests
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: Xolair 300 mgOmalizumab 300 mg for subcutaneous injection | Drug | Omalizumab 300 mg for s.c.injection |
Primary outcome
Change in food challenge threshold (as measured in amount of food protein in milligrams tolerated by oral challenge)
Time frame: 18 weeks
As described open food challenges will be performed according to international guidelines (1) at specified time points and thresholds for a clinical objective reaction as measured in milligrams food protein before (Tr0) and after (TrP) the initial immunoadsorption and then during (TrX) and after cessation (TrW) of treatment with Omalizumab. Challenge thresholds at Tr0, TrP, TrX and TrW will be reported for each patient and compared. Since the study is non-randomized and uncontrolled the individual patient will serve as his/her own control. A 2-step change in threshold will be considered significant.
1 secondary outcome
Change in SPT size (mm) and levels of s-IgE, t-IgE and BaHR
Time frame: 18 weeks
Results and safety
The study was stopped early (reason given: Finished). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Background: PubMed 15180754Bindslev-Jensen C, Ballmer-Weber BK, Bengtsson U, Blanco C, Ebner C, Hourihane J, Knulst AC, Moneret-Vautrin DA, Nekam K, Niggemann B, Osterballe M, Ortolani C, Ring J, Schnopp C, Werfel T; European Academy of Allergology and Clinical Immunology. Standardization of food challenges in patients with immediate reactions to foods--position paper from the European Academy of Allergology and Clinical Immunology. Allergy. 2004 Jul;59(7):690-7. doi: 10.1111/j.1398-9995.2004.00466.x. No abstract available.
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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.
Carsten Bindslev-Jensen, ProfDrMedPhd study director
Odense Research Center for Anaphylaxis
Charlotte G. Moertz, ProfMDPhd study chair
Odense Research Center for Anaphylaxis
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, run by Carsten Bindslev-Jensen at 1 site in Denmark.
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 1 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: stopped early, as of the sponsor's last update on 11 Dec 2023. 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 Denmark. 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?
The study was stopped early (reason given: Finished). Results are not available in the source record.
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 food challenge threshold (as measured in amount of food protein in milligrams tolerated by oral challenge) (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 NCT03964051, 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 11 Dec 2023.