Food AllergyPhase 4NCT04037176
Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)
A Phase 4 study testing Omalizumab in people with Food Allergy, run by Carsten Bindslev-Jensen at 1 site in Denmark.
Trial summary
Food allergy is a common disease in childhood affecting up to 8% of children in Westernized countries. About 30 percent of children with food allergies are allergic to more than one food, most often milk, egg, wheat, peanut and tree nut. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy
- What is being tested?
- Omalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2019to 15 Mar 2022
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- children between 6 and 18 years
- a clinical diagnosis of food allergy to ≥1 food allergen
- a positive SPT (mean wheal diameter > 3 mm)
- s-IgE > 0.35 kIU/l
- a positive food challenge with a threshold at or below 300 mg of protein (443 mg cumulative) in a double blind placebo controlled food challenge (DBPCFC).
- (If the patient is allergic to more than one food allergen, the allergen with the highest probability of fulfilling the inclusion criteria (based on case history, level of s-IgE and when available challenge results within the last year) will be used).
Who cannot join
- t-IgE >1500 kIU/L.
- Significant co-morbidity that might compromise the patient's safety or study outcomes.
- Pregnancy or nursing in the adolescents. Women of childbearing potential have to use safe contraception (intrauterine device or hormonal contraception if sexual active). 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.
- Ongoing treatment with antihistamine or drugs with antihistaminic properties that cannot be paused during the study
- Ongoing treatment with drugs that may impair safety during food challenge e.g. β-blockers or ACE-inhibitors that cannot be paused during the study
- Ongoing treatment with oral glucocorticoids/Omalizumab/allergen immunotherapy (AIT)
Show all 11Show fewer
- Alcohol abuse, abuse of opioids or other drugs in adolescents
- Treated with Omalizumab until ½ years before the study
- Patients/parents who are not supposed to be able to meet the requirements in the protocol
- Patients/parents 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 University Hospital
Odense C, Funen, 5000
About this study
Official title: Treatment With Omalizumab in Food Allergic Children (TOFAC)
Food allergy is a common disease in childhood affecting up to 8% of children in Westernized countries. About 30 percent of children with food allergies are allergic to more than one food, most often milk, egg, wheat, peanut and tree nut. Peanut and hazelnut are common triggers of severe and potentially fatal food-induced anaphylactic reactions. Currently, there is no curative treatment for food allergy. Novel therapies for this potentially life-threatening condition are therefore much needed.
Read the detailed description
Randomized, double-blind, placebo-controlled study to study the effect of Omalizumab on children with food allergy.
Primary endpoint: Change in challenge threshold after 3 months of treatment in patients treated with Omalizumab versus placebo.
Secondary endpoints: Change in challenge threshold at 6 months. Change in Skin Prick Test (SPT), serum markers for allergy (specific IgE, IgG4, BAT (basofil activation test)), severity of comorbidity, and quality of life from at 3 and 6 months. Change in treshold within and between the groups.
The investigator's hypothesis is that increased Omalizumab dose and/or a longer treatment period will increase food allergy threshold.
Within the groups:
- 3 months treatment with Omalizumab in asthma dose versus 6 months with Omalizumab in asthma dose - in primary responders
- 3 months treatment with Omalizumab in asthma dosing versus 3 months additional treatment with Omalizumab in max dose - in primary non-responders
- 3 months treatment with placebo versus 6 months with placebo- in primary placebo-responders
- 3 months treatment with placebo versus 3 months with max dose Omalizumab - placebo cross over to active.
Between the groups:
- 3 months treatment with Omalizumab in asthma dose versus 3 months with max dose Omalizumab
- 6 months treatment with Omalizumab in asthma dose versus 3 months with max dose Omalizumab.
Patients are randomized electronically via an e-CRF prepared by OPEN in RedCap. Assigned 3:1 to Omalizumab or placebo in 13 x 8 block (6:2) by a blinded health care person.
GCP-monitoring is performed by the local GCP-unit at Odense University Hospital
- Conditions
- Food Allergy
- Being tested
- Omalizumab, Placebo
- Keywords
- Omalizumab, 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
Subcutaneous administration every 2. week or every 4. week. Dose is depending of the patients weight and IgE
PlaceboOther
Also called NaCl
Subcutaneous administration every 2. week or every 4. week. Dose is depending of the patients weight and IgE
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab | Active comparator | Omalizumab is a sterile solution in a prefilled syring for subcutaneous injection. The syrings contains 75 mg or 150 mg omalizumab.
75 patients will have Omalizumab in doses depending of body weight and IgE every 2. or 4. week for 6 month Omalizumab is administered subcutaneously Receives: Drug: Omalizumab |
| Placebo | Placebo comparator | Placebo contains sodium chloride 0,9 % in a prefilled syring for subcutaneous injection.
25 patients will have placebo depending of the body weight and IgE every 2. or 4. week in 3 month. They will subsequently get Omalizumab for 3 month if nonresponders.
Placebo is administered subcutaneously Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in challenge threshold (mg food protein tolerated by oral intake)
Change in challenge threshold after 3 months of treatment in patients treated with Omalizumab versus placebo
Measured: 0-3 months
Secondary outcomes (5)
Change in quality of life (validated questionnaire - food allergy quality of life questionnaire (FAQLQ))
To estimate improvement in QoL before and after 3 months and 6 months treatment, using FAQLQ on a seven point scale with one as the best possible score (score 1-7)
Measured: 0-6 months
Change in skin prick test size (mm)
To estimate changes in skin prick test size during the treatment
Measured: 0-6 months
Change in severity of co-morbidity (atopic dermatitis, asthma, allergic rhintitis using clinical severity scores)
To estimate improvement in atopic diseases by evaluation of disease severity (SCORAD atopic dermatitis, VAS and CSMS rhinitis, ATC asthma)
Measured: 0-6 months
Change in levels of serum markers for food allergy (IgE (kIU/L), IgG4 (kIU))
To estimate changes in serum markers for allergy during the treatment
Measured: 0-6 months
Change in levels of serum markers for food allergy BAT test (CD-sens))
To estimate changes in serum markers for allergy during the treatment
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start1 Nov 2019
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomized to treatment with Omalizumab (regular dose of asthma dosing according to total IgE and weight) or placebo (3:1). Primary endpoint after 3 months treatment. Responders (in the active as well as the placebo group) will continue treatment with the same dose of Omalizumab/placebo for a further 3 months. All non-responders will receive maximum dose of Omalizumab (according to weight, but not total IgE) for another 3 months.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carsten Bindslev-Jensen
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals, Thermo Fisher Scientific, Inc
- Responsible party
- Sponsor-investigator, Carsten Bindslev-Jensen, Odense University Hospital
- Investigators
- Carsten Bindslev-Jensen, Prof DM PhD, Study director, Odense Research Center For AnaphylaxisSusanne Halken, Prof DM MD, Study chair, Department of Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037176
- Sponsor's protocol ID
- EudraCT 2018-004427-37
- Status last verified
- Dec 2023
- First submitted
- 10 May 2019
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Omalizumab in Food Allergic Children (TOFAC)
- ClinicalTrials.gov ID
- NCT04037176
- Acronym / sponsor ID
- EudraCT 2018-004427-37
- Conditions
- Food Allergy
- Keywords
- Omalizumab, Xolair
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Carsten Bindslev-JensenUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals, Thermo Fisher Scientific, Inc
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 30 Jul 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.
Food allergy is a common disease in childhood affecting up to 8% of children in Westernized countries. About 30 percent of children with food allergies are allergic to more than one food, most often milk, egg, wheat, peanut and tree nut. Peanut and hazelnut are common triggers of severe and potentially fatal food-induced anaphylactic reactions. Currently, there is no curative treatment for food allergy. Novel therapies for this potentially life-threatening condition are therefore much needed.
Detailed description
Randomized, double-blind, placebo-controlled study to study the effect of Omalizumab on children with food allergy.
Primary endpoint: Change in challenge threshold after 3 months of treatment in patients treated with Omalizumab versus placebo.
Secondary endpoints: Change in challenge threshold at 6 months. Change in Skin Prick Test (SPT), serum markers for allergy (specific IgE, IgG4, BAT (basofil activation test)), severity of comorbidity, and quality of life from at 3 and 6 months. Change in treshold within and between the groups.
The investigator's hypothesis is that increased Omalizumab dose and/or a longer treatment period will increase food allergy threshold.
Within the groups:
- 3 months treatment with Omalizumab in asthma dose versus 6 months with Omalizumab in asthma dose - in primary responders
- 3 months treatment with Omalizumab in asthma dosing versus 3 months additional treatment with Omalizumab in max dose - in primary non-responders
- 3 months treatment with placebo versus 6 months with placebo- in primary placebo-responders
- 3 months treatment with placebo versus 3 months with max dose Omalizumab - placebo cross over to active.
Between the groups:
- 3 months treatment with Omalizumab in asthma dose versus 3 months with max dose Omalizumab
- 6 months treatment with Omalizumab in asthma dose versus 3 months with max dose Omalizumab.
Patients are randomized electronically via an e-CRF prepared by OPEN in RedCap. Assigned 3:1 to Omalizumab or placebo in 13 x 8 block (6:2) by a blinded health care person.
GCP-monitoring is performed by the local GCP-unit at Odense University Hospital
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Eligible participants will be randomized to treatment with Omalizumab (regular dose of asthma dosing according to total IgE and weight) or placebo (3:1). Primary endpoint after 3 months treatment. Responders (in the active as well as the placebo group) will continue treatment with the same dose of Omalizumab/placebo for a further 3 months. All non-responders will receive maximum dose of Omalizumab (according to weight, but not total IgE) for another 3 months.
| Arm | Type | Receives |
|---|---|---|
| Omalizumab | Active comparator | Drug: OmalizumabOmalizumab is a sterile solution in a prefilled syring for subcutaneous injection. The syrings contains 75 mg or 150 mg omalizumab. 75 patients will have Omalizumab in doses depending of body weight and IgE every 2. or 4. week for 6 month Omalizumab is administered subcutaneously |
| Placebo | Placebo comparator | Other: PlaceboPlacebo contains sodium chloride 0,9 % in a prefilled syring for subcutaneous injection. 25 patients will have placebo depending of the body weight and IgE every 2. or 4. week in 3 month. They will subsequently get Omalizumab for 3 month if nonresponders. Placebo is administered subcutaneously |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- children between 6 and 18 years
- a clinical diagnosis of food allergy to ≥1 food allergen
- a positive SPT (mean wheal diameter > 3 mm)
- s-IgE > 0.35 kIU/l
- a positive food challenge with a threshold at or below 300 mg of protein (443 mg cumulative) in a double blind placebo controlled food challenge (DBPCFC).
Key exclusion criteria (11 listed)
- t-IgE >1500 kIU/L.
- Significant co-morbidity that might compromise the patient's safety or study outcomes.
- Pregnancy or nursing in the adolescents. Women of childbearing potential have to use safe contraception (intrauterine device or hormonal contraception if sexual active). 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.
- Ongoing treatment with antihistamine or drugs with antihistaminic properties that cannot be paused during the study
- Ongoing treatment with drugs that may impair safety during food challenge e.g. β-blockers or ACE-inhibitors that cannot be paused during the study
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: XolairSubcutaneous administration every 2. week or every 4. week. Dose is depending of the patients weight and IgE | Drug | Omalizumab |
| PlaceboAlso: NaClSubcutaneous administration every 2. week or every 4. week. Dose is depending of the patients weight and IgE | Other | Placebo |
Primary outcome
Change in challenge threshold (mg food protein tolerated by oral intake)
Time frame: 0-3 months
Change in challenge threshold after 3 months of treatment in patients treated with Omalizumab versus placebo
5 secondary outcomes
Change in quality of life (validated questionnaire - food allergy quality of life questionnaire (FAQLQ))
Time frame: 0-6 months
Change in skin prick test size (mm)
Time frame: 0-6 months
Change in severity of co-morbidity (atopic dermatitis, asthma, allergic rhintitis using clinical severity scores)
Time frame: 0-6 months
Change in levels of serum markers for food allergy (IgE (kIU/L), IgG4 (kIU))
Time frame: 0-6 months
Change in levels of serum markers for food allergy BAT test (CD-sens))
Time frame: 0-6 months
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 5 Dec 2023.
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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, Prof DM PhD study director
Odense Research Center For Anaphylaxis
Susanne Halken, Prof DM MD study chair
Department of Childrens Hospital
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 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 6 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 5 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. Some participants in this study may receive a placebo. 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 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?
Change in challenge threshold (mg food protein tolerated by oral intake) (time frame: 0-3 months). 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 5 Dec 2023.