<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/NCT03793608</url>
  </required_header>
  <id_info>
    <org_study_id>R668-ALG-1702</org_study_id>
    <secondary_id>2018-003133-15</secondary_id>
    <nct_id>NCT03793608</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy</brief_title>
  <official_title>A Study to Evaluate the Efficacy and Safety of Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Regeneron Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The primary objective of the study is to assess the tolerability of peanut protein in&#xD;
      pediatric patients (6-17 years old) treated with dupilumab monotherapy, in which tolerability&#xD;
      is defined as the proportion of patients who safely pass a double-blind placebo-controlled&#xD;
      food challenge (DBPCFC) at week 24.&#xD;
&#xD;
      The secondary objectives are:&#xD;
&#xD;
        -  To determine whether dupilumab treatment improves peanut tolerability, defined as a&#xD;
           change in the cumulative tolerated dose (log transformed) of peanut protein during a&#xD;
           DBPCFC&#xD;
&#xD;
        -  To evaluate the safety and tolerability of dupilumab treatment in peanut allergic&#xD;
           patients&#xD;
&#xD;
        -  To evaluate the effects of dupilumab treatment on the levels of peanut-specific&#xD;
           Immunoglobulin E (IgE)&#xD;
&#xD;
        -  To evaluate the treatment effect of dupilumab on the average wheal size after a titrated&#xD;
           skin prick test (SPT), as measured by area under curve (AUC) of the average wheal size&#xD;
           induced by peanut extract at different concentrations&#xD;
&#xD;
        -  To assess the incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab in&#xD;
           patients over time&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 12, 2019</start_date>
  <completion_date type="Actual">May 12, 2021</completion_date>
  <primary_completion_date type="Actual">February 19, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 24</measure>
    <time_frame>At Week 24</time_frame>
    <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed the DBPCFC with at least 444 mg (cumulative) peanut protein at Week 24 was reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Weeks 24 and 36</measure>
    <time_frame>Weeks 24 and 36</time_frame>
    <description>Change from baseline in cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC at Week 24 and Week 36 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 36</measure>
    <time_frame>At Week 36</time_frame>
    <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 24</measure>
    <time_frame>At Week 24</time_frame>
    <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed a DBPCFC with at least 1044 mg (cumulative) peanut protein at Week 24 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 36</measure>
    <time_frame>At Week 36</time_frame>
    <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 24</measure>
    <time_frame>At Week 24</time_frame>
    <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed a DBPCFC with at least 2044 mg (cumulative) peanut protein at Week 24 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 36</measure>
    <time_frame>At Week 36</time_frame>
    <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Peanut-specific Immunoglobulin E (sIgE) at Weeks 4, 8, 12, 16, 24, and 36</measure>
    <time_frame>Weeks 4, 8, 12, 16, 24, and 36</time_frame>
    <description>Percent change from baseline in sIgE at Weeks 4, 8, 12, 16, 24, and 36 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Titrated Skin Prick Test (SPT) Measured by Average Wheal Size Area Under the Curve (AUC) After Peanut Allergen Stimulation at Different Concentrations at Weeks 4, 12, 24, and 36</measure>
    <time_frame>Weeks 4, 12, 24, and 36</time_frame>
    <description>The titrated SPT is the skin testing for atopic response at different concentrations of peanut extract with saline as negative control and histamine as positive controls. Wheal size induced by peanut extract at each concentration was calculated as average of largest diameter and perpendicular midpoint diameter. The AUC for titrated SPT was calculated using the mean wheal diameter versus the concentration at which the wheal diameter was measured, which was then normalized to concentration. Change from baseline in titrated SPT as measured by average wheal size AUC after peanut allergen stimulation at different concentrations at Weeks 4, 12, 24, and 36 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Grade 2 or Above Allergic Reactions During the DBPCFC at Week 24</measure>
    <time_frame>At Week 24</time_frame>
    <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Percentage of participants with Grade 2 (Moderate) or above allergic reactions during the DBPCFC at Week 24 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Used Epinephrine as a Rescue Medication During the DBPCFC at Week 24</measure>
    <time_frame>At Week 24</time_frame>
    <description>Percentage of participants who used Epinephrine as a rescue medication during the DBPCFC at Week 24 was reported.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Peanut Allergy</condition>
  <arm_group>
    <arm_group_label>Dupilumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open label weight base subcutaneous (SC) injection every two (Q2) weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dupilumab</intervention_name>
    <description>Dupilumab weight-based dosing will be administered subcutaneously (SC) in a single-use, pre-filled syringe every two weeks (Q2W)</description>
    <arm_group_label>Dupilumab</arm_group_label>
    <other_name>REGN668</other_name>
    <other_name>IL4R</other_name>
    <other_name>Dupixent</other_name>
    <other_name>SAR231893</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Patient has a clinical history of allergy to peanuts or peanut-containing foods&#xD;
             (symptom[s] of reaction due to exposure).&#xD;
&#xD;
          -  Experience dose-limiting symptoms at or before the challenge dose of peanut protein on&#xD;
             screening DBPCFC conducted in accordance with Practical Issues in Allergology, Joint&#xD;
             United States/European Union Initiative (PRACTALL) guidelines. And not experiencing&#xD;
             dose limiting symptoms to placebo&#xD;
&#xD;
          -  Serum IgE to peanut of ≥10 kilo units (kUA)/L and/or a SPT to peanut ≥8 mm compared to&#xD;
             a negative control&#xD;
&#xD;
          -  Patients/legal guardians must be trained on the proper use of the epinephrine&#xD;
             autoinjector device to be allowed to enroll in the study&#xD;
&#xD;
          -  Patients with other known food allergies must agree to eliminate these other food&#xD;
             items from their diet so as not to confound the safety and efficacy data from the&#xD;
             study&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Any previous exposure to marketed dupilumab or dupilumab in a clinical trial&#xD;
&#xD;
          -  Member of the clinical site study team or his/her immediate family&#xD;
&#xD;
          -  History of other chronic disease (other than asthma, AD, or allergic rhinitis)&#xD;
             requiring therapy&#xD;
&#xD;
          -  History of frequent or recent severe, life-threatening episode of anaphylaxis or&#xD;
             anaphylactic shock as defined by more than 3 episodes of anaphylaxis within the past&#xD;
             year and/or an episode of anaphylaxis within 60 days of screening DBPCFC&#xD;
&#xD;
          -  History of eosinophilic gastrointestinal disease&#xD;
&#xD;
          -  History of eosinophilic granulomatosis with polyangiitis&#xD;
&#xD;
          -  Severe, unstable asthma at time of enrollment or any patient with Forced Expiratory&#xD;
             Volume in 1 Second (FEV1) &lt;80% of predicted or asthma control questionnaire (ACQ)&gt;1.5&#xD;
&#xD;
          -  Use of systemic corticosteroids within 2 months prior to screening&#xD;
&#xD;
        Note: Other protocol Inclusion/Exclusion Criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trial Management</last_name>
    <role>Study Director</role>
    <affiliation>Regeneron Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regeneron Investigational Site</name>
      <address>
        <city>Mountain View</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Investigational Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Investigational Site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Investigational Site</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48197</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Investigational Site</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Investigational Site</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Investigational Site</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S 1G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Investigational Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <results_first_submitted>February 16, 2022</results_first_submitted>
  <results_first_submitted_qc>May 17, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 19, 2022</results_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Peanut Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All IPD that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in a manuscript. Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.</ipd_access_criteria>
    <ipd_url>https://vivli.org/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 30, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03793608/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 5, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03793608/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Twenty-five participants met eligibility criteria. One of the 25 participants was randomized under the original double-blind placebo-controlled protocol and received placebo-matching dupilumab. Following implementation of Protocol Amendment 1, 24 participants were enrolled under the open-label design &amp; received open-label treatment with dupilumab.</recruitment_details>
      <pre_assignment_details>A double-blind placebo-controlled food challenge (DBPCFC) consisting of increasing amounts of peanut protein up to a cumulative total of 144 mg and a matching placebo challenge consisting of placebo material (oat protein) were given to confirm current peanut allergy. Food challenges were performed on different days in random order (1-day placebo, 1-day peanut protein), at least 24 hours, but not more than 7 days, apart. Both food challenge days were required to evaluate eligibility.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participant enrolled under original double-blind protocol design randomized to receive placebo matched to dupilumab from Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.</description>
        </group>
        <group group_id="P2">
          <title>Dupilumab</title>
          <description>Participants enrolled under open-label treatment protocol with weight of greater than or equal to (&gt;=) 20 kilograms (kg) and less than (&lt;) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of &gt;=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set (SAF)</title>
              <participants_list>
                <participants group_id="P1" count="0">1 participant randomized to placebo was not analyzed and thus excluded from analyses.</participants>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>SAF(all participants who received dupilumab)</population>
      <group_list>
        <group group_id="B1">
          <title>Dupilumab</title>
          <description>Participants enrolled under open-label treatment protocol with weight of greater than or equal to (&gt;=) 20 kilograms (kg) and less than (&lt;) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of &gt;=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.7" spread="3.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 24</title>
        <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed the DBPCFC with at least 444 mg (cumulative) peanut protein at Week 24 was reported.</description>
        <time_frame>At Week 24</time_frame>
        <population>The SAF included all participants who received dupilumab.</population>
        <group_list>
          <group group_id="O1">
            <title>Dupilumab</title>
            <description>Participants enrolled under open-label treatment protocol with weight of greater than or equal to (&gt;=) 20 kilograms (kg) and less than (&lt;) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of &gt;=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 24</title>
          <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed the DBPCFC with at least 444 mg (cumulative) peanut protein at Week 24 was reported.</description>
          <population>The SAF included all participants who received dupilumab.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="1.03" upper_limit="27.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Weeks 24 and 36</title>
        <description>Change from baseline in cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC at Week 24 and Week 36 was reported.</description>
        <time_frame>Weeks 24 and 36</time_frame>
        <population>The SAF included all participants who received dupilumab.</population>
        <group_list>
          <group group_id="O1">
            <title>Dupilumab</title>
            <description>Participants enrolled under open-label treatment protocol with weight of greater than or equal to (&gt;=) 20 kilograms (kg) and less than (&lt;) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of &gt;=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Weeks 24 and 36</title>
          <description>Change from baseline in cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC at Week 24 and Week 36 was reported.</description>
          <population>The SAF included all participants who received dupilumab.</population>
          <units>Log Transformed Milligrams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.69" spread="1.822"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.38" spread="3.096"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 36</title>
        <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.</description>
        <time_frame>At Week 36</time_frame>
        <population>A subset of the SAF that included only participants who passed the DBPCFC of at least 444 mg (cumulative) at Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Dupilumab</title>
            <description>Participants enrolled under open-label treatment protocol with weight of greater than or equal to (&gt;=) 20 kilograms (kg) and less than (&lt;) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of &gt;=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 36</title>
          <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.</description>
          <population>A subset of the SAF that included only participants who passed the DBPCFC of at least 444 mg (cumulative) at Week 24.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 24</title>
        <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed a DBPCFC with at least 1044 mg (cumulative) peanut protein at Week 24 was reported.</description>
        <time_frame>At Week 24</time_frame>
        <population>The SAF included all participants who received dupilumab.</population>
        <group_list>
          <group group_id="O1">
            <title>Dupilumab</title>
            <description>Participants enrolled under open-label treatment protocol with weight of greater than or equal to (&gt;=) 20 kilograms (kg) and less than (&lt;) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of &gt;=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 24</title>
          <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed a DBPCFC with at least 1044 mg (cumulative) peanut protein at Week 24 was reported.</description>
          <population>The SAF included all participants who received dupilumab.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.00" upper_limit="14.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 36</title>
        <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.</description>
        <time_frame>At Week 36</time_frame>
        <population>A subset of the SAF that included only participants who passed the DBPCFC of at least 444 mg (cumulative) at Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Dupilumab</title>
            <description>Participants enrolled under open-label treatment protocol with weight of greater than or equal to (&gt;=) 20 kilograms (kg) and less than (&lt;) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of &gt;=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 36</title>
          <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.</description>
          <population>A subset of the SAF that included only participants who passed the DBPCFC of at least 444 mg (cumulative) at Week 24.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 24</title>
        <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed a DBPCFC with at least 2044 mg (cumulative) peanut protein at Week 24 was reported.</description>
        <time_frame>At Week 24</time_frame>
        <population>The SAF included all participants who received dupilumab.</population>
        <group_list>
          <group group_id="O1">
            <title>Dupilumab</title>
            <description>Participants enrolled under open-label treatment protocol with weight of greater than or equal to (&gt;=) 20 kilograms (kg) and less than (&lt;) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of &gt;=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 24</title>
          <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed a DBPCFC with at least 2044 mg (cumulative) peanut protein at Week 24 was reported.</description>
          <population>The SAF included all participants who received dupilumab.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.00" upper_limit="14.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 36</title>
        <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.</description>
        <time_frame>At Week 36</time_frame>
        <population>A subset of the SAF that included only participants who passed the DBPCFC of at least 444 mg (cumulative) at Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Dupilumab</title>
            <description>Participants enrolled under open-label treatment protocol with weight of greater than or equal to (&gt;=) 20 kilograms (kg) and less than (&lt;) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of &gt;=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 36</title>
          <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.</description>
          <population>A subset of the SAF that included only participants who passed the DBPCFC of at least 444 mg (cumulative) at Week 24.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Peanut-specific Immunoglobulin E (sIgE) at Weeks 4, 8, 12, 16, 24, and 36</title>
        <description>Percent change from baseline in sIgE at Weeks 4, 8, 12, 16, 24, and 36 was reported.</description>
        <time_frame>Weeks 4, 8, 12, 16, 24, and 36</time_frame>
        <population>The SAF included all participants who received dupilumab.</population>
        <group_list>
          <group group_id="O1">
            <title>Dupilumab</title>
            <description>Participants enrolled under open-label treatment protocol with weight of greater than or equal to (&gt;=) 20 kilograms (kg) and less than (&lt;) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of &gt;=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Peanut-specific Immunoglobulin E (sIgE) at Weeks 4, 8, 12, 16, 24, and 36</title>
          <description>Percent change from baseline in sIgE at Weeks 4, 8, 12, 16, 24, and 36 was reported.</description>
          <population>The SAF included all participants who received dupilumab.</population>
          <units>Percent Change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percent change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.86" lower_limit="-19.75" upper_limit="-1.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.03" lower_limit="-33.45" upper_limit="-10.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.10" lower_limit="-40.92" upper_limit="-11.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.22" lower_limit="-47.75" upper_limit="-16.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-49.25" lower_limit="-61.22" upper_limit="-31.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-58.43" lower_limit="-71.25" upper_limit="-45.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Titrated Skin Prick Test (SPT) Measured by Average Wheal Size Area Under the Curve (AUC) After Peanut Allergen Stimulation at Different Concentrations at Weeks 4, 12, 24, and 36</title>
        <description>The titrated SPT is the skin testing for atopic response at different concentrations of peanut extract with saline as negative control and histamine as positive controls. Wheal size induced by peanut extract at each concentration was calculated as average of largest diameter and perpendicular midpoint diameter. The AUC for titrated SPT was calculated using the mean wheal diameter versus the concentration at which the wheal diameter was measured, which was then normalized to concentration. Change from baseline in titrated SPT as measured by average wheal size AUC after peanut allergen stimulation at different concentrations at Weeks 4, 12, 24, and 36 was reported.</description>
        <time_frame>Weeks 4, 12, 24, and 36</time_frame>
        <population>The SAF included all participants who received dupilumab.</population>
        <group_list>
          <group group_id="O1">
            <title>Dupilumab</title>
            <description>Participants enrolled under open-label treatment protocol with weight of greater than or equal to (&gt;=) 20 kilograms (kg) and less than (&lt;) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of &gt;=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Titrated Skin Prick Test (SPT) Measured by Average Wheal Size Area Under the Curve (AUC) After Peanut Allergen Stimulation at Different Concentrations at Weeks 4, 12, 24, and 36</title>
          <description>The titrated SPT is the skin testing for atopic response at different concentrations of peanut extract with saline as negative control and histamine as positive controls. Wheal size induced by peanut extract at each concentration was calculated as average of largest diameter and perpendicular midpoint diameter. The AUC for titrated SPT was calculated using the mean wheal diameter versus the concentration at which the wheal diameter was measured, which was then normalized to concentration. Change from baseline in titrated SPT as measured by average wheal size AUC after peanut allergen stimulation at different concentrations at Weeks 4, 12, 24, and 36 was reported.</description>
          <population>The SAF included all participants who received dupilumab.</population>
          <units>millimeter (mm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.633" spread="2.0604"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.174" spread="2.0618"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.232" spread="2.0610"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.364" spread="2.1419"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Grade 2 or Above Allergic Reactions During the DBPCFC at Week 24</title>
        <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Percentage of participants with Grade 2 (Moderate) or above allergic reactions during the DBPCFC at Week 24 was reported.</description>
        <time_frame>At Week 24</time_frame>
        <population>The SAF included all participants who received dupilumab.</population>
        <group_list>
          <group group_id="O1">
            <title>Dupilumab</title>
            <description>Participants enrolled under open-label treatment protocol with weight of greater than or equal to (&gt;=) 20 kilograms (kg) and less than (&lt;) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of &gt;=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Grade 2 or Above Allergic Reactions During the DBPCFC at Week 24</title>
          <description>Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Percentage of participants with Grade 2 (Moderate) or above allergic reactions during the DBPCFC at Week 24 was reported.</description>
          <population>The SAF included all participants who received dupilumab.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Used Epinephrine as a Rescue Medication During the DBPCFC at Week 24</title>
        <description>Percentage of participants who used Epinephrine as a rescue medication during the DBPCFC at Week 24 was reported.</description>
        <time_frame>At Week 24</time_frame>
        <population>The SAF included all participants who received dupilumab.</population>
        <group_list>
          <group group_id="O1">
            <title>Dupilumab</title>
            <description>Participants enrolled under open-label treatment protocol with weight of greater than or equal to (&gt;=) 20 kilograms (kg) and less than (&lt;) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of &gt;=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Used Epinephrine as a Rescue Medication During the DBPCFC at Week 24</title>
          <description>Percentage of participants who used Epinephrine as a rescue medication during the DBPCFC at Week 24 was reported.</description>
          <population>The SAF included all participants who received dupilumab.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to the end of study (Week 36)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participant enrolled under original double-blind protocol design randomized to receive placebo matched to dupilumab from Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.</description>
        </group>
        <group group_id="E2">
          <title>Dupilumab</title>
          <description>Participants enrolled under open-label treatment protocol with weight of greater than or equal to (&gt;=) 20 kilograms (kg) and less than (&lt;) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of &gt;=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (23.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Medical device pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="8" subjects_affected="3" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trials Administrator</name_or_title>
      <organization>Regeneron Pharmaceuticals, Inc.</organization>
      <phone>844-734-6643</phone>
      <email>clinicaltrials@regeneron.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03793608
org study id: R668-ALG-1702
secondary id: 2018-003133-15
nct id: NCT03793608
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of the study is to assess the tolerability of peanut protein in
      pediatric patients (6-17 years old) treated with dupilumab monotherapy, in which tolerability
      is defined as the proportion of patients who safely pass a double-blind placebo-controlled
      food challenge (DBPCFC) at week 24.

      The secondary objectives are:

        -  To determine whether dupilumab treatment improves peanut tolerability, defined as a
           change in the cumulative tolerated dose (log transformed) of peanut protein during a
           DBPCFC

        -  To evaluate the safety and tolerability of dupilumab treatment in peanut allergic
           patients

        -  To evaluate the effects of dupilumab treatment on the levels of peanut-specific
           Immunoglobulin E (IgE)

        -  To evaluate the treatment effect of dupilumab on the average wheal size after a titrated
           skin prick test (SPT), as measured by area under curve (AUC) of the average wheal size
           induced by peanut extract at different concentrations

        -  To assess the incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab in
           patients over time
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 24
time frame: At Week 24
description: Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed the DBPCFC with at least 444 mg (cumulative) peanut protein at Week 24 was reported.
measure: Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Weeks 24 and 36
time frame: Weeks 24 and 36
description: Change from baseline in cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC at Week 24 and Week 36 was reported.
measure: Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 36
time frame: At Week 36
description: Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.
measure: Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 24
time frame: At Week 24
description: Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed a DBPCFC with at least 1044 mg (cumulative) peanut protein at Week 24 was reported.
measure: Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 36
time frame: At Week 36
description: Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.
measure: Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 24
time frame: At Week 24
description: Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed a DBPCFC with at least 2044 mg (cumulative) peanut protein at Week 24 was reported.
measure: Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 36
time frame: At Week 36
description: Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.
measure: Percent Change From Baseline in Peanut-specific Immunoglobulin E (sIgE) at Weeks 4, 8, 12, 16, 24, and 36
time frame: Weeks 4, 8, 12, 16, 24, and 36
description: Percent change from baseline in sIgE at Weeks 4, 8, 12, 16, 24, and 36 was reported.
measure: Change From Baseline in Titrated Skin Prick Test (SPT) Measured by Average Wheal Size Area Under the Curve (AUC) After Peanut Allergen Stimulation at Different Concentrations at Weeks 4, 12, 24, and 36
time frame: Weeks 4, 12, 24, and 36
description: The titrated SPT is the skin testing for atopic response at different concentrations of peanut extract with saline as negative control and histamine as positive controls. Wheal size induced by peanut extract at each concentration was calculated as average of largest diameter and perpendicular midpoint diameter. The AUC for titrated SPT was calculated using the mean wheal diameter versus the concentration at which the wheal diameter was measured, which was then normalized to concentration. Change from baseline in titrated SPT as measured by average wheal size AUC after peanut allergen stimulation at different concentrations at Weeks 4, 12, 24, and 36 was reported.
measure: Percentage of Participants With Grade 2 or Above Allergic Reactions During the DBPCFC at Week 24
time frame: At Week 24
description: Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Percentage of participants with Grade 2 (Moderate) or above allergic reactions during the DBPCFC at Week 24 was reported.
measure: Percentage of Participants Who Used Epinephrine as a Rescue Medication During the DBPCFC at Week 24
time frame: At Week 24
description: Percentage of participants who used Epinephrine as a rescue medication during the DBPCFC at Week 24 was reported.
arm group label: Dupilumab
arm group type: Experimental
description: Open label weight base subcutaneous (SC) injection every two (Q2) weeks.
intervention type: Drug
intervention name: Dupilumab
description: Dupilumab weight-based dosing will be administered subcutaneously (SC) in a single-use, pre-filled syringe every two weeks (Q2W)
arm group label: Dupilumab
other name: REGN668
other name: IL4R
other name: Dupixent
other name: SAR231893
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
last name: Clinical Trial Management
role: Study Director
affiliation: Regeneron Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Peanut Hypersensitivity
sharing ipd: Yes
ipd description: All IPD that underlie results in a publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.
ipd access criteria: Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in a manuscript. Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.
ipd url: https://vivli.org/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 