Food AllergyNCT04462055
Effectiveness of Dupilumab in Food Allergic Patients With Moderate to Severe Atopic Dermatitis
An observational study of Food Allergy, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
This study evaluates the effectiveness of Dupilumab in food allergic patients with moderate to severe Atopic Dermatitis (AD). Included patients participated in the BioDay Registry. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Food Allergy
- How many people
- 3 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2019to 1 Jul 2022
- How long will I take part?
- 3 Years
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: AD patients with moderate to severe AD who are indicated for treatment with dupilumab and have comorbid food allergy
Who may be able to join
- AD patients with moderate to severe AD who are indicated for treatment with dupilumab
- Peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy allergic subjects, with a well-documented medical history of reactions after ingestion.Peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy specific immunoglobulin E (IgE) level (Phadia CAP-system) higher than 0.35 kU/L or a skin prick test of at least 3 mm
- Positive double-blind placebo-controlled Food Challenge (DBPCFC) with an eliciting dose before the last dose
- Signed Bioday informed consent from subjects
Who cannot join
- Subjects reacting objectively to the placebo at screening.
- Subjects in whom DBCPFC is contra-indicated or in whom DBPCFC is not reliable
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the effectiveness of Dupilumab in food allergic patients with moderate to severe Atopic Dermatitis (AD). Included patients participated in the BioDay Registry.
Read the detailed description
The positive results of the dupilumab studies in AD, asthma and nasal polyposis with chronic sinusitis validate the fundamental role for IL-4 and IL-13 in the pathogenesis of these diseases, and add to the possibility that these cytokines are also critically involved in other related allergic/atopic (type 2 immune) diseases that are often co-morbidly associated with AD, such as food allergy.
- Conditions
- Food Allergy
- Keywords
- Dupilumab, Food allergy, Atopic Dermatitis, BioDay Registry
- Medical subject headings
- Food Hypersensitivity, Dermatitis, Atopic
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of Dupilumab on change in clinical eliciting dose (i.e. lowest dose causing an allergic reaction) in subjects with peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy
AD patients with moderate to severe AD who are indicated for treatment with dupilumab and have symptomatic food allergy to peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy will be included.
Measured: Each subject will undergo two oral food challenges: one at screening and one during dupilumab treatment with a treatment duration of at least 28 weeks.
Secondary outcomes (3)
To evaluate the effect of Dupilumab on food allergy related quality of life
The food allergy related quality of life will be measured with the Food allergy Quality of Life Questionnaire adult form (FAQLQ-AF)
The FAQLQ-AF assesses health-related quality of life (HRQL) and contains a total of 29 items. The total FAQLQ-AF score is the mean score of all items with a range of 1 'no impairment' to 7 'maximal impairment'.
Measured: Before the first food challenge and 3 months after the second food challenge during their visit conform Bioday protocol.
To evaluate the effect of Dupilumab on the level of specific IgE (sIgE) antibodies
sIgE in blood will be measured using the ImmunoCAP system (Thermofisher, Uppsala, Sweden). Levels of ≥ 0.35 kU/L will be considered positive. Depending on the food the following will be tested: peanut: extract, Ara h 2, 6; hazelnut: extract, cor a 1, 9, 14; walnut: extract; cow's milk: extract; hen's egg: extract; soybean: extract
Measured: sIgE in blood will be measured every three months during dupilumab treatment
To evaluate the effect of Dupilumab on the biological activity of IgE for peanut and hazelnut and measurement of biomarkers profile
For patients treated with Dupilumab left over serum is stored except as the patient objects.
Patients treated with Dupilumab asked to participate to the biobank eczema and/or biobank acute inflammation.
Measured: The basophil activation test and the measurement of biomarkers on Luminex at baseline and after at least 28 weeks of dupilumab treatment (e.g. at time of second challenge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 May 2019
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Why it stopped: Not feasible to include patients (due to e.g. COVID-19, patients with severe reactions not willing to undergo 2 food challenges, lower number of eligible patients than expected)
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 UMC UtrechtThe 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
- Prospective
- Enrolment
- 3 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr M.S. de Bruin-Weller, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462055
- Sponsor's protocol ID
- 19-197
- Status last verified
- Jul 2022
- First submitted
- 17 Jun 2020
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dupilumab in Food Allergic Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04462055
- Acronym / sponsor ID
- 19-197
- Conditions
- Food Allergy
- Keywords
- Dupilumab, Food allergy, Atopic Dermatitis, BioDay Registry
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not feasible to include patients (due to e.g. COVID-19, patients with severe reactions not willing to undergo 2 food challenges, lower number of eligible patients than expected)
- Enrolment
- 3 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 8 Jul 2020 (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 study evaluates the effectiveness of Dupilumab in food allergic patients with moderate to severe Atopic Dermatitis (AD). Included patients participated in the BioDay Registry.
Detailed description
The positive results of the dupilumab studies in AD, asthma and nasal polyposis with chronic sinusitis validate the fundamental role for IL-4 and IL-13 in the pathogenesis of these diseases, and add to the possibility that these cytokines are also critically involved in other related allergic/atopic (type 2 immune) diseases that are often co-morbidly associated with AD, such as food allergy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- AD patients with moderate to severe AD who are indicated for treatment with dupilumab and have comorbid food allergy
Key inclusion criteria (4 listed)
- AD patients with moderate to severe AD who are indicated for treatment with dupilumab
- Peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy allergic subjects, with a well-documented medical history of reactions after ingestion.Peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy specific immunoglobulin E (IgE) level (Phadia CAP-system) higher than 0.35 kU/L or a skin prick test of at least 3 mm
- Positive double-blind placebo-controlled Food Challenge (DBPCFC) with an eliciting dose before the last dose
- Signed Bioday informed consent from subjects
Key exclusion criteria (2 listed)
- Subjects reacting objectively to the placebo at screening.
- Subjects in whom DBCPFC is contra-indicated or in whom DBPCFC is not reliable
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
To evaluate the effect of Dupilumab on change in clinical eliciting dose (i.e. lowest dose causing an allergic reaction) in subjects with peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy
Time frame: Each subject will undergo two oral food challenges: one at screening and one during dupilumab treatment with a treatment duration of at least 28 weeks.
AD patients with moderate to severe AD who are indicated for treatment with dupilumab and have symptomatic food allergy to peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy will be included.
3 secondary outcomes
To evaluate the effect of Dupilumab on food allergy related quality of life
Time frame: Before the first food challenge and 3 months after the second food challenge during their visit conform Bioday protocol.
To evaluate the effect of Dupilumab on the level of specific IgE (sIgE) antibodies
Time frame: sIgE in blood will be measured every three months during dupilumab treatment
To evaluate the effect of Dupilumab on the biological activity of IgE for peanut and hazelnut and measurement of biomarkers profile
Time frame: The basophil activation test and the measurement of biomarkers on Luminex at baseline and after at least 28 weeks of dupilumab treatment (e.g. at time of second challenge)
Results and safety
The study was stopped early (reason given: Not feasible to include patients (due to e.g. COVID-19, patients with severe reactions not willing to undergo 2 food challenges, lower number of eligible patients than expected)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Allergy, run by UMC Utrecht at 1 site in Netherlands.
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 4 inclusion and 2 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 29 Jul 2022. 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 Netherlands. 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 was stopped early (reason given: Not feasible to include patients (due to e.g. COVID-19, patients with severe reactions not willing to undergo 2 food challenges, lower number of eligible patients than expected)). 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?
To evaluate the effect of Dupilumab on change in clinical eliciting dose (i.e. lowest dose causing an allergic reaction) in subjects with peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy (time frame: Each subject will undergo two oral food challenges: one at screening and one during dupilumab treatment with a treatment duration of at least 28 weeks.). 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 29 Jul 2022.