<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/NCT03292484</url>
  </required_header>
  <id_info>
    <org_study_id>ARC008</org_study_id>
    <nct_id>NCT03292484</nct_id>
  </id_info>
  <brief_title>Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)</brief_title>
  <official_title>A Multicenter, Open-Label, Longer-Term Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 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>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess AR101's safety, tolerability and efficacy over an&#xD;
      extended dosing period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is enrolling participants by invitation only. This is an open-label,&#xD;
      international, longer-term extension study for eligible subjects who have participated in one&#xD;
      of the Aimmune AR101 clinical studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">October 11, 2017</start_date>
  <completion_date type="Anticipated">December 2027</completion_date>
  <primary_completion_date type="Anticipated">December 2026</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse events including serious adverse events (Safety and Tolerability)</measure>
    <time_frame>Approximately 10 years</time_frame>
    <description>To describe safety and tolerability during longer-term administration of AR101 and follow-up observation after the last dose of AR101</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peanut allergy desensitization through extended maintenance dosing of AR101</measure>
    <time_frame>Following 3-5 years of AR101 treatment</time_frame>
    <description>Proportion of subjects who have completed 3-5 years of AR101 (depending on age group) who tolerate each food challenge dose double-blind, placebo-controlled food challenge (DBPCFC) to a maximum 2000mg peanut protein</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">950</enrollment>
  <condition>Peanut Allergy</condition>
  <arm_group>
    <arm_group_label>Treatment Pathway 1, 2, 3, 4, 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be assigned to one of five treatment pathways when first enrolled into ARC008, which is dependent on the treatment received (AR101 or placebo) during the parent study and their tolerance of this treatment regimen (e.g., daily or non-daily schedule).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AR101</intervention_name>
    <description>AR101</description>
    <arm_group_label>Treatment Pathway 1, 2, 3, 4, 5</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Prior participation in an Aimmune AR101 clinical study or any future clinical study&#xD;
             that identifies ARC008 as a follow-on study option in the protocol&#xD;
&#xD;
          -  Written informed consent and/or assent from subjects/guardians as appropriate&#xD;
&#xD;
          -  Use of effective birth control by sexually active female subjects of childbearing&#xD;
             potential&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Did not complete a minimum of 3 months of AR101 maintenance therapy if the subject was&#xD;
             assigned to AR101 in the parent study&#xD;
&#xD;
          -  Currently receiving or received within 5 years prior to Screening any type of peanut&#xD;
             or other food allergen immunotherapy, except AR101 or unless allowed in the parent&#xD;
             study, and except during the follow-up observation period in this study&#xD;
&#xD;
          -  Discontinued early from the parent study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sharon Vadher</last_name>
    <role>Study Chair</role>
    <affiliation>Director, Clinical Operations</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alabama Allergy and Asthma Center</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Research of Arizona, Allergy, Asthma &amp; Immunology Associates</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Banner Univ. of Arizona Medical Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>Jonathan Corren, M.D., Inc.</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy &amp; Asthma Associates of Southern California</name>
      <address>
        <city>Mission Viejo</city>
        <state>California</state>
        <zip>92691</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sean N. Parker Center for Allergy and Asthma Research LPCH El Camino Hospital</name>
      <address>
        <city>Mountain View</city>
        <state>California</state>
        <zip>94040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peninsula Research Associates</name>
      <address>
        <city>Rolling Hills Estates</city>
        <state>California</state>
        <zip>90274</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy &amp; Asthma Medical Group and Research Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rady Children's Hospital, Div. of Allergy &amp; Immunology</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSF, Benioff Children's Hospital - Allergy and Immunology</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>95148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy &amp; Asthma Associates of Santa Clara Valley Research Center</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Medical Center, Santa Monica</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay Area Allergy</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asthma &amp; Allergy Associates</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Jewish Health</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Allergy &amp; Asthma Centers, P.C.</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's National Health System</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sher Allergy Specialists - Center for Cough</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33778</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy Associates of the Palm Beaches</name>
      <address>
        <city>North Palm Beach</city>
        <state>Florida</state>
        <zip>33408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarasota Clinical Research</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida, Asthma Allergy &amp; Immunology Clinical Research Unit</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Healthcare of Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30329</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Allergy &amp; Asthma Clinic</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Idaho Allergy and Research</name>
      <address>
        <city>Eagle</city>
        <state>Idaho</state>
        <zip>83616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611-2605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Chicago Medicine, Comer Children's Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sneeze, Wheeze, &amp; Itch Associates</name>
      <address>
        <city>Normal</city>
        <state>Illinois</state>
        <zip>61761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riley Children's Specialists</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deaconess Clinic, Inc.</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Allergy &amp; Asthma Research Institute</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chesapeake Clinical Research, Inc.</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Hospital, Pediatric Clinical Research Unit</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</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>Univ. of Michigan Health System, Div. of Allergy and Clinical Immunology</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute Inc.</name>
      <address>
        <city>Plymouth</city>
        <state>Minnesota</state>
        <zip>55441</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy on Broadway</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlantic Research Center</name>
      <address>
        <city>Ocean City</city>
        <state>New Jersey</state>
        <zip>07712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princeton Center for Clinical Research</name>
      <address>
        <city>Skillman</city>
        <state>New Jersey</state>
        <zip>08558</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health System</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jaffe Food Allergy Institute Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ. of Rochester Medical Center, Golisano Children's Hosp.</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill, Clinical &amp; Translational Research Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of Charlotte</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28277</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>Bernstein Clinical Research Center, LLC</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Institute of Allergy and Asthma Clinical Research</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia Asthma &amp; Allergy Clinic</name>
      <address>
        <city>Clackamas</city>
        <state>Oregon</state>
        <zip>97015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baker Allergy, Asthma and Dermatology</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97223</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 Hospital of Pittsburgh of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Allergy and Asthma Research, LLC</name>
      <address>
        <city>North Charleston</city>
        <state>South Carolina</state>
        <zip>29420</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Le Bonheur Children's Hospital, Outpatient Bldg.</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specially for Children Allergy, Asthma and Immunology Clinic</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Health</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Sky Medical Research</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Children's Hospital, Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Texas Health Research</name>
      <address>
        <city>New Braunfels</city>
        <state>Texas</state>
        <zip>78130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASTHMA, Inc. Clinical Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98115-2024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McMaster University Medical Center</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 3Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Triple A Lab</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S 1G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cheema Research Inc.</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L5A 3V4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Allergy Research Corp</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1G 6C6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gordon Sussman Clinical Research</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4V 1R2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants</name>
      <address>
        <city>Bordeaux</city>
        <state>Cedex</state>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Vincent de Paul- Service d'Allergologie</name>
      <address>
        <city>Lille</city>
        <state>Cedex</state>
        <zip>59020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jeanne de Flandre Hospital -Paediatric Allergy and Pulmonology Center</name>
      <address>
        <city>Lille</city>
        <state>Cedex</state>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <state>Cedex</state>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Universitaetsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cork University Hospital, UCC Department of Paediatrics and Child Health</name>
      <address>
        <city>Cork</city>
        <zip>T12 DC4A</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Children's Research Centre, Our Lady's Children's Hospital Crumlin</name>
      <address>
        <city>Dublin</city>
        <zip>D12 V004</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Padova</name>
      <address>
        <city>Padova</city>
        <state>Province Of Padua</state>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beatrix Children's Hospital, University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9700 RB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9713 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañón</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Infantil Universitario Niño Jesús, Servicio de Alergia</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Madrid Hospital Clinico San Carlos, Servicio de Alergia</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sachsska Children and Youth Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>118 83</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leicester Royal infirmary</name>
      <address>
        <city>Leicester</city>
        <state>Leicestershire</state>
        <zip>LE1 5WW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James Paget University Hospital</name>
      <address>
        <city>Gorleston-on-Sea</city>
        <state>Norfolk</state>
        <zip>NR31 6LA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy &amp; St Thomas' NHS Foundation Trust, Children Allergies Department</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Mary's Hospital - Paediatric Research Unit</name>
      <address>
        <city>London</city>
        <zip>W2 1NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Clinical Research Facility, Royal Manchester Children's Hospital</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheffield Children's Hospital</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Southampton Foundation NHS Trust</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Manchester University Hospitals</name>
      <address>
        <city>Wythenshawe</city>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.aimmune.com/medical-information-request-form/</url>
    <description>Click to request more information about this study.</description>
  </link>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>February 24, 2022</last_update_submitted>
  <last_update_submitted_qc>February 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>AR101</keyword>
  <keyword>Characterized Peanut Allergen</keyword>
  <keyword>OIT (oral immunotherapy)</keyword>
  <keyword>Peanut Allergy</keyword>
  <keyword>Allergy</keyword>
  <keyword>Peanut-Allergic Children</keyword>
  <keyword>Peanut-Allergic Adults</keyword>
  <keyword>Desensitization</keyword>
  <keyword>CPNA (Characterized Peanut Allergen)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Peanut Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03292484
org study id: ARC008
nct id: NCT03292484
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess AR101's safety, tolerability and efficacy over an
      extended dosing period.
This study is enrolling participants by invitation only. This is an open-label,
      international, longer-term extension study for eligible subjects who have participated in one
      of the Aimmune AR101 clinical studies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of adverse events including serious adverse events (Safety and Tolerability)
time frame: Approximately 10 years
description: To describe safety and tolerability during longer-term administration of AR101 and follow-up observation after the last dose of AR101
measure: Peanut allergy desensitization through extended maintenance dosing of AR101
time frame: Following 3-5 years of AR101 treatment
description: Proportion of subjects who have completed 3-5 years of AR101 (depending on age group) who tolerate each food challenge dose double-blind, placebo-controlled food challenge (DBPCFC) to a maximum 2000mg peanut protein
arm group label: Treatment Pathway 1, 2, 3, 4, 5
arm group type: Experimental
description: Subjects will be assigned to one of five treatment pathways when first enrolled into ARC008, which is dependent on the treatment received (AR101 or placebo) during the parent study and their tolerance of this treatment regimen (e.g., daily or non-daily schedule).
intervention type: Biological
intervention name: AR101
description: AR101
arm group label: Treatment Pathway 1, 2, 3, 4, 5
criteria: 
gender: All
minimum age: 1 Year
maximum age: 55 Years
healthy volunteers: No
last name: Sharon Vadher
role: Study Chair
affiliation: Director, Clinical Operations
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: France
country: Germany
country: Ireland
country: Italy
country: Netherlands
country: Spain
country: Sweden
country: United Kingdom
country: United States
url: https://www.aimmune.com/medical-information-request-form/
description: Click to request more information about this study.
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Peanut Hypersensitivity
sharing ipd: Undecided