<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/NCT02198664</url>
  </required_header>
  <id_info>
    <org_study_id>ARC002</org_study_id>
    <nct_id>NCT02198664</nct_id>
  </id_info>
  <brief_title>Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study</brief_title>
  <official_title>Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen (CPNA) Peanut Oral Immunotherapy (OIT) Safety Follow-On Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aimmune Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aimmune Therapeutics, Inc.</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>
      This is a multi-center, open-label, follow-on study to gather additional information on the&#xD;
      safety and tolerability of oral desensitization with CPNA in the subjects who participated in&#xD;
      ARC001.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This phase 2, open-label, follow-on, multicenter study was designed to gather additional&#xD;
      information on the safety, tolerability, and efficacy of oral desensitization with AR101 in&#xD;
      subjects who participated in study ARC001 (NCT01987817) as follows:&#xD;
&#xD;
        -  Group 1 (ARC001 placebo): Subjects who received placebo in study ARC001&#xD;
&#xD;
        -  Group 2 (ARC001 AR101): Subjects who received AR101 and tolerated up to 300 mg peanut&#xD;
           protein (443 mg cumulative) in the DBPCFC at the end of study ARC001&#xD;
&#xD;
      All subjects will receive daily oral dosing of peanut OIT (oral immunotherapy) in the form of&#xD;
      Characterized Peanut Allergen (CPNA).&#xD;
&#xD;
      Study Duration - 12-90 weeks before reaching the Extended Maintenance Phase. All Subjects may&#xD;
      continue Extended Maintenance Phase until CPNA becomes commercially available or the study is&#xD;
      terminated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 27, 2014</start_date>
  <completion_date type="Actual">January 4, 2018</completion_date>
  <primary_completion_date type="Actual">January 4, 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months</measure>
    <time_frame>Up to 90 weeks</time_frame>
    <description>TEAEs are any event starting during or after the active treatment period. If a subject has multiple occurrences of TEAEs, the subject is presented once in the respective subject count (n).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC</measure>
    <time_frame>Up to 36 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC.</measure>
    <time_frame>Up to 60 weeks.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein</measure>
    <time_frame>Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)</time_frame>
    <description>The single highest tolerated dose of peanut protein with no more than mild symptoms during the up-dosing DBPCFC and the change from baseline was evaluated for the ARC001 placebo completer population. The single highest tolerated dose of peanut protein with no more than mild symptoms during the maintenance DBPCFC and the change from up-dosing DBPCFC was evaluated for each group (ARC001 AR101 and ARC001 placebo) and overall for the food challenge completer population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated</measure>
    <time_frame>Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)</time_frame>
    <description>The maximum dose of peanut protein tolerated with no more than mild symptoms during the up-dosing and maintenance DBPCFCs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance</measure>
    <time_frame>Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance</measure>
    <time_frame>Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance</measure>
    <time_frame>Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC</measure>
    <time_frame>Up to 36 weeks for up-dosing</time_frame>
    <description>Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during up-dosing DBPCFC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC</measure>
    <time_frame>Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)</time_frame>
    <description>Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during maintenance DBPCFC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance.</measure>
    <time_frame>Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)</time_frame>
    <description>A 100-mm Visual Analog Scale (VAS) was used by the investigators for the Physician Global Assessment of disease activity as a marker for safety. The investigator was to assign a single integrated overall disease activity score ranging from 0 to 100 mm. Zero indicated no disease activity and 100 indicated very severe disease activity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Peanut Allergy</condition>
  <arm_group>
    <arm_group_label>ARC001 placebo group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects who received placebo in study ARC001.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ARC001 AR101 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AR101 - Peanut protein capsule</intervention_name>
    <description>Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
    <arm_group_label>ARC001 AR101 group</arm_group_label>
    <arm_group_label>ARC001 placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Completion of ARC001 study&#xD;
&#xD;
          -  No change in the status of any longitudinally applicable ARC001 inclusion criteria&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Early termination from ARC001&#xD;
&#xD;
          -  Failure to tolerate 300 mg of peanut protein in the ARC001 exit food challenge&#xD;
&#xD;
          -  A lapse in dosing of more than 10 days from completion of ARC001&#xD;
&#xD;
          -  Change in the status of any longitudinally applicable ARC001 exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Director of Regulatory Affairs</last_name>
    <role>Study Director</role>
    <affiliation>Aimmune Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arkansas Children's Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina Chapel HIll</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>25799</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Medical Center Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <results_first_submitted>August 4, 2021</results_first_submitted>
  <results_first_submitted_qc>November 8, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 9, 2021</results_first_posted>
  <disposition_first_submitted>August 16, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>August 19, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 21, 2019</disposition_first_posted>
  <last_update_submitted>November 8, 2021</last_update_submitted>
  <last_update_submitted_qc>November 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Characterized Peanut Allergen</keyword>
  <keyword>Peanut</keyword>
  <keyword>OIT</keyword>
  <keyword>Oral Desensitization</keyword>
  <keyword>Peanut Allergen</keyword>
  <keyword>Peanut-Allergic Children</keyword>
  <keyword>Children</keyword>
  <keyword>Peanut-Allergic Adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peanut Hypersensitivity</mesh_term>
  </condition_browse>
  <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>August 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT02198664/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>April 2, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT02198664/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ARC001 Placebo Group</title>
          <description>Subjects who received placebo in study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
        </group>
        <group group_id="P2">
          <title>ARC001 AR101 Group</title>
          <description>Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Failure to tolerate</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not stated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ARC001 Placebo Group</title>
          <description>Subjects who received placebo in study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
        </group>
        <group group_id="B2">
          <title>ARC001 AR101 Group</title>
          <description>Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="26"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="47"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.5" lower_limit="5.0" upper_limit="14.0"/>
                    <measurement group_id="B2" value="8.0" lower_limit="4.0" upper_limit="21.0"/>
                    <measurement group_id="B3" value="8.0" lower_limit="4.0" upper_limit="21.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>4-17 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18-26 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="30"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months</title>
        <description>TEAEs are any event starting during or after the active treatment period. If a subject has multiple occurrences of TEAEs, the subject is presented once in the respective subject count (n).</description>
        <time_frame>Up to 90 weeks</time_frame>
        <population>The Safety Population (those who received any amount of AR101)</population>
        <group_list>
          <group group_id="O1">
            <title>ARC001 Placebo Group</title>
            <description>Subjects who received placebo in study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
          </group>
          <group group_id="O2">
            <title>ARC001 AR101 Group</title>
            <description>Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months</title>
          <description>TEAEs are any event starting during or after the active treatment period. If a subject has multiple occurrences of TEAEs, the subject is presented once in the respective subject count (n).</description>
          <population>The Safety Population (those who received any amount of AR101)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Grade 3 or Higher TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any TEAE Related to Study Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any TEAE Leading to Study Treatment Temporarily Withdrawn</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any TEAE Event Leading to Study Treatment Permanently Withdrawn</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Treatment-Related Hypersensitivity Adverse Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Serious TEAE leading to Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC</title>
        <time_frame>Up to 36 weeks</time_frame>
        <population>The Safety Population (those who received any amount of AR101). Only results for the &quot;ARC001 AR101 Group&quot; is reported as only subjects in this group had Up-dosing DBPCFC in ARC002 study.</population>
        <group_list>
          <group group_id="O1">
            <title>ARC001 Placebo Group</title>
            <description>Subjects who received placebo in study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC</title>
          <population>The Safety Population (those who received any amount of AR101). Only results for the &quot;ARC001 AR101 Group&quot; is reported as only subjects in this group had Up-dosing DBPCFC in ARC002 study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Up-dosing DBPCFC: Responder at 300 mg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Up-dosing DBPCFC: Responder at 600 mg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC.</title>
        <time_frame>Up to 60 weeks.</time_frame>
        <population>The Safety Population (those who received any amount of AR101). Multiple food challenge dose levels were given at each DBPCFC, so results at 300 mg and 600 mg for Maintenance DBPCFC are not expected to match those for Up-dosing DBPCFC.</population>
        <group_list>
          <group group_id="O1">
            <title>ARC001 Placebo Group</title>
            <description>Subjects who received placebo in study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
          </group>
          <group group_id="O2">
            <title>ARC001 AR101 Group</title>
            <description>Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC.</title>
          <population>The Safety Population (those who received any amount of AR101). Multiple food challenge dose levels were given at each DBPCFC, so results at 300 mg and 600 mg for Maintenance DBPCFC are not expected to match those for Up-dosing DBPCFC.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Maintenance DBPCFC: Responder at 300 mg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maintenance DBPCC: Responder at 600 mg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maintenance DBPCC: Responder at 1000 mg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein</title>
        <description>The single highest tolerated dose of peanut protein with no more than mild symptoms during the up-dosing DBPCFC and the change from baseline was evaluated for the ARC001 placebo completer population. The single highest tolerated dose of peanut protein with no more than mild symptoms during the maintenance DBPCFC and the change from up-dosing DBPCFC was evaluated for each group (ARC001 AR101 and ARC001 placebo) and overall for the food challenge completer population.</description>
        <time_frame>Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)</time_frame>
        <population>Only includes food challenge completer population</population>
        <group_list>
          <group group_id="O1">
            <title>ARC001 Placebo Group</title>
            <description>Subjects who received placebo in study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
          </group>
          <group group_id="O2">
            <title>ARC001 AR101 Group</title>
            <description>Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein</title>
          <description>The single highest tolerated dose of peanut protein with no more than mild symptoms during the up-dosing DBPCFC and the change from baseline was evaluated for the ARC001 placebo completer population. The single highest tolerated dose of peanut protein with no more than mild symptoms during the maintenance DBPCFC and the change from up-dosing DBPCFC was evaluated for each group (ARC001 AR101 and ARC001 placebo) and overall for the food challenge completer population.</description>
          <population>Only includes food challenge completer population</population>
          <units>mg</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AR101 baseline (mg) [2]</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.90" spread="4.37"/>
                    <measurement group_id="O2" value="NA" spread="NA">Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002&#xD;
The single highest tolerated dose from the ARC001 exit DBPCFC was defined as the AR101 baseline for subjects in the ARC001 placebo group.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Up-dosing DBPCFC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="501.2" spread="1.55"/>
                    <measurement group_id="O2" value="524.8" spread="1.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maintenance DBPCFC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="776.2" spread="1.41"/>
                    <measurement group_id="O2" value="758.6" spread="1.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated</title>
        <description>The maximum dose of peanut protein tolerated with no more than mild symptoms during the up-dosing and maintenance DBPCFCs</description>
        <time_frame>Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)</time_frame>
        <population>Only includes food challenge completer population</population>
        <group_list>
          <group group_id="O1">
            <title>ARC001 Placebo Group</title>
            <description>Subjects who received placebo in study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
          </group>
          <group group_id="O2">
            <title>ARC001 AR101 Group</title>
            <description>Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated</title>
          <description>The maximum dose of peanut protein tolerated with no more than mild symptoms during the up-dosing and maintenance DBPCFCs</description>
          <population>Only includes food challenge completer population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Up-dosing DBPCFC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>100 mg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>300 mg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>600 mg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1000 mg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Not administer 1000 mg dose at Up-dosing DBPCFC.</measurement>
                    <measurement group_id="O2" value="NA">Not administer 1000 mg dose at Up-dosing DBPCFC.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maintenance DBPCFC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>100 mg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>300 mg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>600 mg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1000 mg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance</title>
        <time_frame>Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)</time_frame>
        <population>The Safety Population (those who received any amount of AR101)</population>
        <group_list>
          <group group_id="O1">
            <title>ARC001 Placebo Group</title>
            <description>Subjects who received placebo in study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
          </group>
          <group group_id="O2">
            <title>ARC001 AR101 Group</title>
            <description>Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance</title>
          <population>The Safety Population (those who received any amount of AR101)</population>
          <units>kU/L</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: Peanut-specific IgE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.826" spread="2.8864"/>
                    <measurement group_id="O2" value="NA" spread="NA">[1] Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Up-dosing: Peanut-specific IgE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.145" spread="2.9154"/>
                    <measurement group_id="O2" value="29.964" spread="4.4817"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extended maintenance: Peanut-specific IgE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.880" spread="6.7531"/>
                    <measurement group_id="O2" value="10.381" spread="4.0149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline: Peanut-specific IgE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.387" spread="2.2479"/>
                    <measurement group_id="O2" value="NA" spread="NA">[1] Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from up-dosing: Peanut-specific IgE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.364" spread="2.8292"/>
                    <measurement group_id="O2" value="0.228" spread="2.0544"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance</title>
        <time_frame>Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)</time_frame>
        <population>The Safety Population (those who received any amount of AR101)</population>
        <group_list>
          <group group_id="O1">
            <title>ARC001 Placebo Group</title>
            <description>Subjects who received placebo in study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
          </group>
          <group group_id="O2">
            <title>ARC001 AR101 Group</title>
            <description>Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance</title>
          <population>The Safety Population (those who received any amount of AR101)</population>
          <units>μg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: Peanut-specific IgG4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.538" spread="2.4351"/>
                    <measurement group_id="O2" value="NA" spread="NA">Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Up-dosing: Peanut-specific IgG4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.004" spread="3.8962"/>
                    <measurement group_id="O2" value="4.096" spread="3.9749"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extended maintenance: Peanut-specific IgG4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.755" spread="3.6328"/>
                    <measurement group_id="O2" value="12.429" spread="2.8292"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline: Peanut-specific IgG4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.429" spread="2.2705"/>
                    <measurement group_id="O2" value="NA" spread="NA">Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from up-dosing: Peanut-specific IgG4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.682" spread="3.1268"/>
                    <measurement group_id="O2" value="2.746" spread="3.4556"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance</title>
        <time_frame>Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)</time_frame>
        <population>The Safety Population (those who received any amount of AR101)</population>
        <group_list>
          <group group_id="O1">
            <title>ARC001 Placebo Group</title>
            <description>Subjects who received placebo in study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
          </group>
          <group group_id="O2">
            <title>ARC001 AR101 Group</title>
            <description>Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance</title>
          <population>The Safety Population (those who received any amount of AR101)</population>
          <units>millimeter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Peanut wheal diameter; baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8" spread="6.29"/>
                    <measurement group_id="O2" value="NA" spread="NA">Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Peanut wheal diameter; up-dosing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="4.62"/>
                    <measurement group_id="O2" value="6.6" spread="3.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Peanut wheal diameter; extended maintenance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" spread="5.77"/>
                    <measurement group_id="O2" value="5.1" spread="3.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline: Peanut wheal diameter</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="6.52"/>
                    <measurement group_id="O2" value="NA" spread="NA">Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from up-dosing: Peanut wheal diameter</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="4.72"/>
                    <measurement group_id="O2" value="-0.7" spread="2.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Peanut erythema/flare; baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.6" spread="17.69"/>
                    <measurement group_id="O2" value="NA" spread="NA">Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Peanut erythema/flare; up-dosing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.8" spread="12.05"/>
                    <measurement group_id="O2" value="21.8" spread="8.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Peanut erythema/flare; extended maintenance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.2" spread="19.73"/>
                    <measurement group_id="O2" value="14.7" spread="11.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline: peanut erythema/flare</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.7" spread="15.35"/>
                    <measurement group_id="O2" value="NA" spread="NA">Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from up-dosing: peanut erythema/flare</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="11.55"/>
                    <measurement group_id="O2" value="-5.4" spread="9.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC</title>
        <description>Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during up-dosing DBPCFC</description>
        <time_frame>Up to 36 weeks for up-dosing</time_frame>
        <population>Only subjects who completed the food challenge at each challenge dose during the Up-dosing DBPCFC were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>ARC001 Placebo Group</title>
            <description>Subjects who received placebo in study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg</description>
          </group>
          <group group_id="O2">
            <title>ARC001 AR101 Group</title>
            <description>Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC</title>
          <description>Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during up-dosing DBPCFC</description>
          <population>Only subjects who completed the food challenge at each challenge dose during the Up-dosing DBPCFC were analyzed</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 mg</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10 mg</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 mg</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>100 mg</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>300 mg</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>600 mg</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC</title>
        <description>Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during maintenance DBPCFC</description>
        <time_frame>Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)</time_frame>
        <population>Only subjects who completed the food challenge at each challenge dose during the Maintenance DBPCFC were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>ARC001 Placebo Group</title>
            <description>Subjects who received placebo in study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg).</description>
          </group>
          <group group_id="O2">
            <title>ARC001 AR101 Group</title>
            <description>Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC</title>
          <description>Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during maintenance DBPCFC</description>
          <population>Only subjects who completed the food challenge at each challenge dose during the Maintenance DBPCFC were analyzed</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 mg</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10 mg</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 mg</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>100 mg</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>300 mg</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>600 mg</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1000 mg</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance.</title>
        <description>A 100-mm Visual Analog Scale (VAS) was used by the investigators for the Physician Global Assessment of disease activity as a marker for safety. The investigator was to assign a single integrated overall disease activity score ranging from 0 to 100 mm. Zero indicated no disease activity and 100 indicated very severe disease activity.</description>
        <time_frame>Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)</time_frame>
        <population>The Safety Population (those who received any amount of AR101)</population>
        <group_list>
          <group group_id="O1">
            <title>ARC001 Placebo Group</title>
            <description>Subjects who received placebo in study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
          </group>
          <group group_id="O2">
            <title>ARC001 AR101 Group</title>
            <description>Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance.</title>
          <description>A 100-mm Visual Analog Scale (VAS) was used by the investigators for the Physician Global Assessment of disease activity as a marker for safety. The investigator was to assign a single integrated overall disease activity score ranging from 0 to 100 mm. Zero indicated no disease activity and 100 indicated very severe disease activity.</description>
          <population>The Safety Population (those who received any amount of AR101)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.4" spread="24.31"/>
                    <measurement group_id="O2" value="NA" spread="NA">[1] Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Up-dosing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.9" spread="21.42"/>
                    <measurement group_id="O2" value="25.6" spread="17.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extended maintenance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.5" spread="25.03"/>
                    <measurement group_id="O2" value="20.1" spread="12.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.30" spread="34.50"/>
                    <measurement group_id="O2" value="NA" spread="NA">[1] Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from up-dosing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.00" spread="38.87"/>
                    <measurement group_id="O2" value="-15.5" spread="20.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>90 weeks</time_frame>
      <desc>A multi-page adverse event form was used allowing all adverse events to be submitted through a single reporting mechanism. Study investigators will provide the Coordinating Center with data of all SAEs as defined per the protocol on an ongoing basis, within 24 h of site awareness of the event. The sponsor's Medical Monitor will review each SAE report and will determine whether the SAE must be reported to FDA on an expedited basis.</desc>
      <group_list>
        <group group_id="E1">
          <title>ARC001 Placebo Group</title>
          <description>Subjects who received placebo in study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
        </group>
        <group group_id="E2">
          <title>ARC001 AR101 Group</title>
          <description>Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.&#xD;
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (16.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (16.0)</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="26" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pruritus</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Oral pruritus</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Lip swelling</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Lip pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nasal turbinate hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </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>Institutions cannot publish until the multi-center sponsor publication is published&#xD;
Or, institutions cannot publish until 18 months after study completion&#xD;
And Sponsor review of any publications is required prior to any institution publications according to contractual agreements</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director of Regulatory Affairs</name_or_title>
      <organization>Aimmune Therapeutics, Inc.</organization>
      <phone>650-409-5164</phone>
      <email>RegulatoryAffairs@aimmune.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/NCT02198664
org study id: ARC002
nct id: NCT02198664
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a multi-center, open-label, follow-on study to gather additional information on the
      safety and tolerability of oral desensitization with CPNA in the subjects who participated in
      ARC001.
This phase 2, open-label, follow-on, multicenter study was designed to gather additional
      information on the safety, tolerability, and efficacy of oral desensitization with AR101 in
      subjects who participated in study ARC001 (NCT01987817) as follows:

        -  Group 1 (ARC001 placebo): Subjects who received placebo in study ARC001

        -  Group 2 (ARC001 AR101): Subjects who received AR101 and tolerated up to 300 mg peanut
           protein (443 mg cumulative) in the DBPCFC at the end of study ARC001

      All subjects will receive daily oral dosing of peanut OIT (oral immunotherapy) in the form of
      Characterized Peanut Allergen (CPNA).

      Study Duration - 12-90 weeks before reaching the Extended Maintenance Phase. All Subjects may
      continue Extended Maintenance Phase until CPNA becomes commercially available or the study is
      terminated.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months
time frame: Up to 90 weeks
description: TEAEs are any event starting during or after the active treatment period. If a subject has multiple occurrences of TEAEs, the subject is presented once in the respective subject count (n).
measure: The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC
time frame: Up to 36 weeks
measure: The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC.
time frame: Up to 60 weeks.
measure: Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein
time frame: Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)
description: The single highest tolerated dose of peanut protein with no more than mild symptoms during the up-dosing DBPCFC and the change from baseline was evaluated for the ARC001 placebo completer population. The single highest tolerated dose of peanut protein with no more than mild symptoms during the maintenance DBPCFC and the change from up-dosing DBPCFC was evaluated for each group (ARC001 AR101 and ARC001 placebo) and overall for the food challenge completer population.
measure: Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated
time frame: Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)
description: The maximum dose of peanut protein tolerated with no more than mild symptoms during the up-dosing and maintenance DBPCFCs
measure: Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance
time frame: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
measure: Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance
time frame: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
measure: Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance
time frame: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
measure: Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC
time frame: Up to 36 weeks for up-dosing
description: Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during up-dosing DBPCFC
measure: Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC
time frame: Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)
description: Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during maintenance DBPCFC
measure: Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance.
time frame: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
description: A 100-mm Visual Analog Scale (VAS) was used by the investigators for the Physician Global Assessment of disease activity as a marker for safety. The investigator was to assign a single integrated overall disease activity score ranging from 0 to 100 mm. Zero indicated no disease activity and 100 indicated very severe disease activity.
arm group label: ARC001 placebo group
arm group type: Experimental
description: Subjects who received placebo in study ARC001.
arm group label: ARC001 AR101 group
arm group type: Experimental
description: Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.
intervention type: Biological
intervention name: AR101 - Peanut protein capsule
description: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
arm group label: ARC001 AR101 group
arm group label: ARC001 placebo group
criteria: 
gender: All
minimum age: 4 Years
maximum age: 26 Years
healthy volunteers: No
last name: Director of Regulatory Affairs
role: Study Director
affiliation: Aimmune Therapeutics
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Peanut Hypersensitivity
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 