<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04462055</url>
  </required_header>
  <id_info>
    <org_study_id>19-197</org_study_id>
    <nct_id>NCT04462055</nct_id>
  </id_info>
  <brief_title>Effectiveness of Dupilumab in Food Allergic Patients With Moderate to Severe Atopic Dermatitis</brief_title>
  <official_title>Effectiveness of Dupilumab in Food Allergic Patients With Moderate to Severe Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UMC Utrecht</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UMC Utrecht</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effectiveness of Dupilumab in food allergic patients with moderate&#xD;
      to severe Atopic Dermatitis (AD). Included patients participated in the BioDay Registry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The positive results of the dupilumab studies in AD, asthma and nasal polyposis with chronic&#xD;
      sinusitis validate the fundamental role for IL-4 and IL-13 in the pathogenesis of these&#xD;
      diseases, and add to the possibility that these cytokines are also critically involved in&#xD;
      other related allergic/atopic (type 2 immune) diseases that are often co-morbidly associated&#xD;
      with AD, such as food allergy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Not feasible to include patients (due to e.g. COVID-19, patients with severe reactions not&#xD;
    willing to undergo 2 food challenges, lower number of eligible patients than expected)&#xD;
  </why_stopped>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">July 1, 2022</completion_date>
  <primary_completion_date type="Actual">July 1, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <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</measure>
    <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.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the effect of Dupilumab on food allergy related quality of life</measure>
    <time_frame>Before the first food challenge and 3 months after the second food challenge during their visit conform Bioday protocol.</time_frame>
    <description>The food allergy related quality of life will be measured with the Food allergy Quality of Life Questionnaire adult form (FAQLQ-AF)&#xD;
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'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the effect of Dupilumab on the level of specific IgE (sIgE) antibodies</measure>
    <time_frame>sIgE in blood will be measured every three months during dupilumab treatment</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the effect of Dupilumab on the biological activity of IgE for peanut and hazelnut and measurement of biomarkers profile</measure>
    <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)</time_frame>
    <description>For patients treated with Dupilumab left over serum is stored except as the patient objects.&#xD;
Patients treated with Dupilumab asked to participate to the biobank eczema and/or biobank acute inflammation.</description>
  </secondary_outcome>
  <enrollment type="Actual">3</enrollment>
  <condition>Food Allergy</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        AD patients with moderate to severe AD who are indicated for treatment with dupilumab and&#xD;
        have comorbid food allergy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. AD patients with moderate to severe AD who are indicated for treatment with dupilumab&#xD;
&#xD;
          2. Peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy allergic&#xD;
             subjects, with a well-documented medical history of reactions after ingestion.Peanut,&#xD;
             hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy specific immunoglobulin&#xD;
             E (IgE) level (Phadia CAP-system) higher than 0.35 kU/L or a skin prick test of at&#xD;
             least 3 mm&#xD;
&#xD;
          3. Positive double-blind placebo-controlled Food Challenge (DBPCFC) with an eliciting&#xD;
             dose before the last dose&#xD;
&#xD;
          4. Signed Bioday informed consent from subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects reacting objectively to the placebo at screening.&#xD;
&#xD;
          2. Subjects in whom DBCPFC is contra-indicated or in whom DBPCFC is not reliable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Medical Centre Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 27, 2022</last_update_submitted>
  <last_update_submitted_qc>July 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>UMC Utrecht</investigator_affiliation>
    <investigator_full_name>Dr M.S. de Bruin-Weller</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Dupilumab</keyword>
  <keyword>Food allergy</keyword>
  <keyword>Atopic Dermatitis</keyword>
  <keyword>BioDay Registry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
    <mesh_term>Food Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04462055
org study id: 19-197
nct id: NCT04462055
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
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.
description: 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.
measure: 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.
description: 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'.
measure: 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
description: 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
measure: 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)
description: 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.
Blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: UMC Utrecht
investigator full name: Dr M.S. de Bruin-Weller
investigator title: Principal Investigator
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Food Hypersensitivity
sharing ipd: No