<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/NCT04492683</url>
  </required_header>
  <id_info>
    <org_study_id>V1605-201</org_study_id>
    <nct_id>NCT04492683</nct_id>
  </id_info>
  <brief_title>Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children</brief_title>
  <acronym>APTITUDE</acronym>
  <official_title>A Phase 2 Study to Evaluate the Sensitivity, Specificity and Safety of DBV1605, a Ready-to-Use Atopy Patch Test for the Diagnosis of Non-Immunoglobulin E Mediated Cow's Milk Allergy in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DBV Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DBV Technologies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study to assess the diagnostic accuracy (sensitivity, specificity, positive and negative&#xD;
      predictive value) of DBV1605 for the diagnosis of non-Immunoglobulin E (IgE) mediated cow's&#xD;
      milk allergy (CMA) in children with symptoms suggestive of non-IgE mediated CMA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 28, 2020</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic performance of DBV1605</measure>
    <time_frame>48 hours</time_frame>
    <description>Sensitivity and specificity of DBV1605 based on skin reactivity readings after 48 hours will be compared to the results of the DBPCFC in subjects of the disease group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic performance of DBV1605</measure>
    <time_frame>72 hours</time_frame>
    <description>Sensitivity and specificity of DBV1605 based on skin reactivity readings after 72 hours will be compared to the results of the DBPCFC in subjects of the disease group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to day 49</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">230</enrollment>
  <condition>Cow's Milk Allergy</condition>
  <arm_group>
    <arm_group_label>Disease group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One active patch and one control patch applied to subjects with clinical symptoms suggestive of non-IgE mediated CMA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One active patch and one control patch applied to subjects without any history of allergic disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>DBV1605</intervention_name>
    <description>Ready-to-use atopy patch test for diagnostic use containing 2 distinct patches:&#xD;
One active patch containing a dry deposit of 180 μg of cow's milk proteins&#xD;
One control patch with the same design as the active patch but devoid of any formulation.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Disease group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        DISEASE GROUP&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subjects aged &gt; 28 days to ≤ 24 months at Screening Visit&#xD;
&#xD;
          -  Subjects with clinical symptoms suggestive of non-IgE mediated Cow's Milk Allergy&#xD;
&#xD;
          -  Subjects with any type of diet containing daily products with cow's milk protein (e.g.&#xD;
             cow's milk consumption, cow's milk partial elimination, partially hydrolyzed milk)&#xD;
             prior to Screening Visit or who have started a cow's milk elimination diet not more&#xD;
             than 4 weeks prior to Screening Visit,&#xD;
&#xD;
          -  Subjects/parents/guardians who agree to follow a strict cow's milk-free diet and other&#xD;
             mammalian milks (such as sheep and goat's milk) as per study requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with an established diagnosis of non-IgE mediated CMA&#xD;
&#xD;
          -  Breast-fed subject at Screening Visit&#xD;
&#xD;
          -  Subjects with a convincing history of IgE-mediated CMA&#xD;
&#xD;
          -  Subjects on a cow's milk protein-free diet including an AA-based formula or an&#xD;
             extensively hydrolyzed formula initiated more than 4 weeks prior to Screening Visit.&#xD;
&#xD;
          -  Generalized dermatologic disease (e.g. severe atopic dermatitis, ) extending widely on&#xD;
             the skin.&#xD;
&#xD;
          -  Any contraindication to a cow's milk challenge&#xD;
&#xD;
        CONTROL GROUP&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subjects aged &gt; 28 days to ≤ 24 months at Screening visit&#xD;
&#xD;
          -  Subjects having no medical history of any type of allergy&#xD;
&#xD;
          -  Subjects who tolerate at least 200 mL of cow's milk or equivalent dairy foods daily&#xD;
             within 4 weeks prior to Screening visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with history of persistent gastro-intestinal symptoms&#xD;
&#xD;
          -  Exclusively breast-fed subjects at Screening visit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>29 Days</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Titan Clinical Research</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85004</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yadwinder Dhillon, MD</last_name>
      <phone>623-262-0930</phone>
      <email>y.dhillon@viableresearch.org</email>
    </contact>
    <investigator>
      <last_name>Yadwinder Dhillon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Arizona Health Science</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85719</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heather Cassell, MD</last_name>
      <phone>520-626-8517</phone>
      <email>heathercassell@peds.arizona.edu</email>
    </contact>
    <investigator>
      <last_name>Heather Cassell, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of California, Rady Children's Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Stephanie Leonard, MD</last_name>
      <phone>858-966-5961</phone>
      <email>saleonard@ucsd.edu</email>
    </contact>
    <investigator>
      <last_name>Stephanie Leonard, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Children's National Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010-2916</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hemant Sharma, MD</last_name>
      <phone>202-476-4416</phone>
      <email>Hsharma@childrensnational.org</email>
    </contact>
    <investigator>
      <last_name>Hemant Sharma, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Eastern Research Inc.</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33013</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Biomedical Research, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33184</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lilia Roque Guerrero, MD</last_name>
      <phone>305-671-3686</phone>
      <email>LroqueMD@Bio-MedicalResearch.com</email>
    </contact>
    <investigator>
      <last_name>Lilia Roque Guerrero</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sunshine Research Center</name>
      <address>
        <city>Opa-locka</city>
        <state>Florida</state>
        <zip>33054</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Pierre Blemur, MD</last_name>
      <phone>305-688-0791</phone>
      <email>maitemenendez@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Pierre Blemur, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Allergy Center at Brookstone - Research Department</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>MedPharmics, LLC - Lafayette</name>
      <address>
        <city>Lafayette</city>
        <state>Louisiana</state>
        <zip>70508</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jibran Atwi, MD</last_name>
      <phone>337-451-0663</phone>
      <email>jibranatwi@medpharmics.com</email>
    </contact>
    <investigator>
      <last_name>Jibran Atwi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Massachusets General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wayne Shreffler, MD</last_name>
      <phone>617-726-6147</phone>
      <email>wshreffler@mgh.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Wayne Shreffler, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>New York University Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Nowak-Wegzryn, MD</last_name>
      <phone>212-263-1255</phone>
      <email>Anna.Nowak-wegrzyn@nyulangone.org</email>
    </contact>
    <investigator>
      <last_name>Anna Nowak-Wegzryn, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mary Grace Baker, MD</last_name>
      <phone>212-241-5548</phone>
      <email>marygrace.baker@mssm.edu</email>
    </contact>
    <investigator>
      <last_name>Mary Grace Baker, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH)</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Kirsi M Jarvinen-Seppo, MD</last_name>
      <phone>585-276-7190</phone>
      <email>Kirsi_Jarvinen-Seppo@urmc.rochester.edu</email>
    </contact>
    <investigator>
      <last_name>Kirsi M Jarvinen-Seppo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Amal Assa'ad, MD</last_name>
      <phone>513-636-6771</phone>
      <email>amal.assa'ad@cchmc.org</email>
    </contact>
    <investigator>
      <last_name>Amal Assa'ad, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Case Western Reserve University (CWRU) - University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Sferra, MD</last_name>
      <phone>216-844-1765</phone>
      <phone_ext>27860</phone_ext>
      <email>Thomas.Sferra@UHhospitals.org</email>
    </contact>
    <investigator>
      <last_name>Thomas Sferra, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205-2664</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Stukus, MD</last_name>
      <phone>614-722-4808</phone>
      <email>david.stukus@nationwidechildrens.org</email>
    </contact>
    <investigator>
      <last_name>David Stukus, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Allergy, Asthma &amp; Clinical Research Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martha Tarpay, MD</last_name>
      <phone>405-752-0393</phone>
      <email>mtarpay@mtarpay.com</email>
    </contact>
    <investigator>
      <last_name>Martha Tarpay, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Terri Brown-Whitehorn, MD</last_name>
      <phone>215-590-2549</phone>
      <email>brownte@email.chop.edu</email>
    </contact>
    <investigator>
      <last_name>Terri Brown-Whitehorn, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Alliance for Multispecialty Research, LLC - New Roy Office</name>
      <address>
        <city>Roy</city>
        <state>Utah</state>
        <zip>84067</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anthony G Pruitt, MD</last_name>
      <phone>801-773-8644</phone>
      <email>Tony.pruitt@amrllc.com</email>
    </contact>
    <investigator>
      <last_name>Anthony G Pruitt, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Halton Pediatric Allergy</name>
      <address>
        <city>Burlington</city>
        <state>Ontario</state>
        <zip>L7L 6W6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Douglas Mack, MD</last_name>
      <phone>9053159543</phone>
      <email>dougpmack@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Douglas Mack, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hamilton Allergy</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L4A 1S4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason Ohayon, MD</last_name>
      <phone>905-525-4674</phone>
      <email>ohayonj@hamiltonallergy.ca</email>
    </contact>
    <investigator>
      <last_name>Jason Ohayon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gordon Sussman Clinical Research Inc.</name>
      <address>
        <city>North York</city>
        <state>Ontario</state>
        <zip>M3B 356</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Federico II</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roberto Berni Canani, MD</last_name>
      <phone>390 815451278</phone>
      <email>berni@unina.it</email>
    </contact>
    <investigator>
      <last_name>Roberto Berni Canani, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Padova</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonella Muraro</last_name>
      <phone>39 335 7080827</phone>
      <email>muraro@centroallergiealimentari.eu</email>
    </contact>
    <investigator>
      <last_name>Antonella Muraro, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Pediatria ad Indirizzo Gastroenterologico - Ospedale pediatrico Di Cristina</name>
      <address>
        <city>Palermo</city>
        <zip>90134</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francesca Cavataio</last_name>
      <phone>39 916666192</phone>
      <email>francesca.cavataio@arnascivico.it</email>
    </contact>
    <investigator>
      <last_name>Francesca Cavataio, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IRCCS Fondazione Policlinico San Matteo - Pediatria</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amelia Licari, MD</last_name>
      <phone>39 0382502629</phone>
      <email>a.licari@smatteo.pv.it</email>
    </contact>
    <investigator>
      <last_name>Amelia Licari, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara</name>
      <address>
        <city>Pisa</city>
        <zip>56126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Diego Peroni</last_name>
      <phone>39 050993180</phone>
      <email>perodiego@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Diego Peroni, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale Pediatrico Bambino Gesù</name>
      <address>
        <city>Roma</city>
        <zip>00146</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Alessandro Fiocchi, MD</last_name>
      <phone>39 06 6859 2309</phone>
      <email>alessandro.fiocchi@allegriallergia.net</email>
    </contact>
    <investigator>
      <last_name>Alessandro Fiocchi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Università la Sapienza U.O.C di Gastroenterologia, Epatologia e Endoscopia Digestiva Pediatrica</name>
      <address>
        <city>Roma</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marina Aloi, MD</last_name>
      <phone>39 0649979387</phone>
      <email>marina.aloi@uniroma1.it</email>
    </contact>
    <investigator>
      <last_name>Marina Aloi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma</name>
      <address>
        <city>Verona</city>
        <zip>37134</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giorgio Piacentini, MD</last_name>
      <phone>39 045 812 7120</phone>
      <email>giorgio.piacentini@univr.it</email>
    </contact>
    <investigator>
      <last_name>Giorgio Piacentini, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital of Lithuanian University of Health Sciences Kauno Klinikos</name>
      <address>
        <city>Kaunas</city>
        <zip>50161</zip>
        <country>Lithuania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jolanta Kudzyte, MD</last_name>
      <phone>37068685286</phone>
      <email>jolantakudzyte@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Jolanta Kudzyte, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vilnius University Hospital Santaros Klinikos, Centre of Pediatrics</name>
      <address>
        <city>Vilnius</city>
        <zip>08406</zip>
        <country>Lithuania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Odilija Rudzeviciene, MD</last_name>
      <phone>37060820243</phone>
      <email>odilija.rudzeviciene@santa.lt</email>
    </contact>
    <investigator>
      <last_name>Odilija Rudzeviciene, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Italy</country>
    <country>Lithuania</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>August 9, 2022</last_update_submitted>
  <last_update_submitted_qc>August 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non-IgE mediated CMA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Milk Hypersensitivity</mesh_term>
  </condition_browse>
  <!-- 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/NCT04492683
org study id: V1605-201
nct id: NCT04492683
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Study to assess the diagnostic accuracy (sensitivity, specificity, positive and negative
      predictive value) of DBV1605 for the diagnosis of non-Immunoglobulin E (IgE) mediated cow's
      milk allergy (CMA) in children with symptoms suggestive of non-IgE mediated CMA.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Diagnostic performance of DBV1605
time frame: 48 hours
description: Sensitivity and specificity of DBV1605 based on skin reactivity readings after 48 hours will be compared to the results of the DBPCFC in subjects of the disease group.
measure: Diagnostic performance of DBV1605
time frame: 72 hours
description: Sensitivity and specificity of DBV1605 based on skin reactivity readings after 72 hours will be compared to the results of the DBPCFC in subjects of the disease group.
measure: Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)
time frame: Up to day 49
arm group label: Disease group
arm group type: Experimental
description: One active patch and one control patch applied to subjects with clinical symptoms suggestive of non-IgE mediated CMA
arm group label: Control group
arm group type: Experimental
description: One active patch and one control patch applied to subjects without any history of allergic disease
intervention type: Combination Product
intervention name: DBV1605
description: Ready-to-use atopy patch test for diagnostic use containing 2 distinct patches:
One active patch containing a dry deposit of 180 μg of cow's milk proteins
One control patch with the same design as the active patch but devoid of any formulation.
arm group label: Control group
arm group label: Disease group
criteria: 
gender: All
minimum age: 29 Days
maximum age: 24 Months
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
country: Italy
country: Lithuania
country: United States
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Milk Hypersensitivity