<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/NCT04442269</url>
  </required_header>
  <id_info>
    <org_study_id>R668-ABPA-1923</org_study_id>
    <secondary_id>2019-002619-24</secondary_id>
    <nct_id>NCT04442269</nct_id>
  </id_info>
  <brief_title>Investigating Treatment With Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis (ABPA) (LIBERTY ABPA AIRED)</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Regeneron Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to evaluate the efficacy of dupilumab on lung function&#xD;
      in participants with Allergic Bronchopulmonary Aspergillosis (ABPA).&#xD;
&#xD;
      The secondary objectives of the study are:&#xD;
&#xD;
        -  To evaluate the effects of dupilumab on exacerbations in participants with ABPA&#xD;
&#xD;
        -  To evaluate the effects of dupilumab on ABPA-related exacerbations&#xD;
&#xD;
        -  To evaluate the effects of dupilumab on hospitalization/emergency department (ED)/urgent&#xD;
           care visits in participants with ABPA&#xD;
&#xD;
        -  To evaluate the effects of dupilumab on asthma control in participants with ABPA&#xD;
&#xD;
        -  To evaluate the effects of dupilumab on health-related quality of life (HRQoL) in&#xD;
           participants with ABPA&#xD;
&#xD;
        -  To evaluate the effects of dupilumab on serum total immunoglobulin E (IgE) and&#xD;
           Aspergillus-specific IgE concentrations&#xD;
&#xD;
        -  To evaluate the effects of dupilumab on Fractional exhaled Nitric Oxide (FeNO) levels&#xD;
&#xD;
        -  To evaluate safety and tolerability of dupilumab in participants with ABPA&#xD;
&#xD;
        -  To evaluate dupilumab concentrations in serum and the incidence of anti-dupilumab&#xD;
           antibodies in participants with ABPA&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Anticipated">November 13, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 21, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) compared to placebo</measure>
    <time_frame>At Week 24</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Annualized rate of severe respiratory exacerbations</measure>
    <time_frame>Over the 24 to 52 Week Treatment Period</time_frame>
    <description>Defined as new onset of symptoms or clinical worsening of respiratory symptoms requiring systemic corticosteroid treatment for ≥3 consecutive days; for patients who are on maintenance systemic corticosteroids, at least double the dose of maintenance systemic corticosteroids for ≥3 consecutive days (with or without antibiotic therapy if indicated)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annualized rate of ABPA-related exacerbations</measure>
    <time_frame>Over the 24 to 52 Week Treatment Period</time_frame>
    <description>Defined as severe respiratory exacerbations (as defined above) that are associated with a doubling of serum total Immunoglobulin E (IgE) from the prior pre-exacerbation value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annualized rate of severe respiratory exacerbations requiring either hospitalization or observation for &gt;24 hours in an ED/urgent care facility</measure>
    <time_frame>Over the 24 to 52 Week Treatment Period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Asthma Control Questionnaire (ACQ)-5</measure>
    <time_frame>Over the 24 to 52 Week Treatment Period</time_frame>
    <description>ACQ is completed by patient to measure both the adequacy of asthma control and change in asthma control, which occurs either spontaneously or as a result of treatment. The ACQ-5 score is the mean of the first 5 questions, between 0 (totally controlled) and 6 (severely uncontrolled). A higher score indicates lower asthma control. Patients with a score below 1.0 reflect adequately controlled asthma and patients with scores above 1.0 reflect inadequately controlled asthma. The optimal cut-point score of 1.50 should be used to be confident that a patient has inadequately controlled asthma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score</measure>
    <time_frame>Over the 24 to 52 Week Treatment Period</time_frame>
    <description>SGRQ will be completed by the patient to measure and quantify health status in adult patients with chronic airflow limitation. Total score ranges from 0 to 100. Scores by dimension are calculated for three domains: Symptoms, Activity, and Impacts (Psychosocial). Lower score indicates better Quality of Life (QoL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants achieving a reduction in the SGRQ score of 4 points or greater from baseline</measure>
    <time_frame>Up to 52 Weeks</time_frame>
    <description>SGRQ will be completed by the patient to measure and quantify health status in adult patients with chronic airflow limitation. Total score ranges from 0 to 100. Scores by dimension are calculated for three domains: Symptoms, Activity, and Impacts (Psychosocial). Lower score indicates better Quality of Life (QoL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change from baseline in total IgE in serum</measure>
    <time_frame>Over the 24 to 52 Week Treatment Period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change from baseline in A fumigatus-specific IgE in serum</measure>
    <time_frame>Over the 24 to 52 Week Treatment Period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change from baseline in fractional exhaled nitric oxide (FeNO)</measure>
    <time_frame>Over the 24 to 52 Week Treatment Period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute change from baseline in FeNO</measure>
    <time_frame>Over the 24 to 52 Week Treatment Period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment-emergent adverse events (TEAEs) from baseline</measure>
    <time_frame>Through the end of the 52 Week Treatment Period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment-emergent anti-drug antibody (ADA) responses and titer over time</measure>
    <time_frame>Up to 64 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentrations of functional dupilumab in serum by treatment regimen</measure>
    <time_frame>Up to 64 Weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Allergic Bronchopulmonary Aspergillosis</condition>
  <arm_group>
    <arm_group_label>dupilumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Loading subcutaneous (SC) dose on day 1, followed by SC dose, every two weeks (Q2W)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Matching dupilumab without active substance</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dupilumab</intervention_name>
    <description>Single-use prefilled glass syringe administered by subcutaneous (SC) injection.</description>
    <arm_group_label>dupilumab</arm_group_label>
    <other_name>• DUPIXENT</other_name>
    <other_name>• REGN668</other_name>
    <other_name>• SAR231893</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of both ABPA and asthma&#xD;
&#xD;
          -  On a maintenance therapy for their asthma with controller medication which must&#xD;
             include inhaled corticosteroids (ICS) and may include 1 or more additional controller&#xD;
             medications including a long-acting beta agonist (LABA), leukotriene receptor&#xD;
             antagonist (LTRA), and/or long-acting muscarinic receptor antagonist (LAMA), etc for&#xD;
             at least 12 weeks, with a stable dose and regimen with no change in the dose or&#xD;
             frequency of administration for at least 4 weeks prior to the screening visit and&#xD;
             between the screening and baseline/randomization visits&#xD;
&#xD;
          -  For participants on OCS (oral corticosteroid): must be on a chronic stable dose (no&#xD;
             change in the dose) of OCS of up to 10 mg/day (for participants taking daily&#xD;
             corticosteroids) or up to 30 mg every alternate day (for participants taking alternate&#xD;
             day corticosteroids) (prednisone/prednisolone or the equivalent) for at least 4 weeks&#xD;
             prior to the screening visit and between the screening and the baseline/randomization&#xD;
             visit&#xD;
&#xD;
          -  Must have experienced ≥1 severe respiratory exacerbation requiring treatment with&#xD;
             systemic corticosteroids or hospitalization or treatment in ED/urgent care within 12&#xD;
             months prior to the screening visit or must be receiving chronic stable low-dose OCS&#xD;
             per above criteria&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Weight less than 30.0 kilograms&#xD;
&#xD;
          -  Current smoker or e-cigarette user, cessation of smoking or e-cigarette use within 6&#xD;
             months prior to randomization, or &gt;=10 pack-years smoking history&#xD;
&#xD;
          -  Post-bronchodilator FEV1 &lt;30% predicted normal at screening&#xD;
&#xD;
          -  Respiratory exacerbation requiring systemic corticosteroids within 4 weeks prior to&#xD;
             screening and between screening and baseline visit (for patients on daily or alternate&#xD;
             day OCS, exacerbation requiring at least double the maintenance dose of&#xD;
             corticosteroids)&#xD;
&#xD;
          -  Upper or lower respiratory tract infection within the 4 weeks prior to screening&#xD;
             (visit 1) or between the screening and randomization visits&#xD;
&#xD;
          -  Significant chronic pulmonary disease other than asthma complicated with ABPA (eg,&#xD;
             physician-diagnosed bronchiectasis due to a condition other than ABPA; cystic&#xD;
             fibrosis; sarcoidosis; interstitial lung disease not due to ABPA; chronic obstructive&#xD;
             pulmonary disease [COPD] not due to ABPA; hypereosinophilic syndrome; etc), a&#xD;
             diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil&#xD;
             counts&#xD;
&#xD;
          -  Diagnosis or suspected diagnosis of eosinophilic granulomatosis with polyangiitis&#xD;
             (EGPA) (also called Churg-Strauss Syndrome)&#xD;
&#xD;
        NOTE: Other protocol defined inclusion / exclusion criteria applies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trial Management</last_name>
    <role>Study Director</role>
    <affiliation>Regeneron Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Atherton</city>
        <state>California</state>
        <zip>94027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Stockton</city>
        <state>California</state>
        <zip>95207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Fort Mitchell</city>
        <state>Kentucky</state>
        <zip>41017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Brick</city>
        <state>New Jersey</state>
        <zip>08724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>DuBois</city>
        <state>Pennsylvania</state>
        <zip>15801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Haskovo</city>
        <zip>6305</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Razgrad</city>
        <zip>7200</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Smolyan</city>
        <zip>4700</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Sofia</city>
        <zip>1142</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1G 6C6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Le Mans</city>
        <zip>72000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Marseille</city>
        <zip>13015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Reims Cedex</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Suresnes</city>
        <zip>92151</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Leipzig</city>
        <state>Saxony</state>
        <zip>4357</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Berlin</city>
        <zip>10717</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60389</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Fukuyama</city>
        <zip>7200001</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>259-1193</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Nagoya</city>
        <zip>454-8509</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Naka-gun</city>
        <zip>3191113</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Sakai</city>
        <zip>591-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Yanagawa</city>
        <zip>8320059</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Yokohama</city>
        <zip>231-8682</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Amsterdam</city>
        <state>North Holland</state>
        <zip>1105AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Arnhem</city>
        <zip>6815</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Breda</city>
        <zip>4818 CK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Eindhoven</city>
        <zip>5623</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Zutphen</city>
        <zip>7207</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Bialystok</city>
        <zip>15-044</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Gdansk</city>
        <zip>80402</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Oradea</city>
        <state>Bihor</state>
        <zip>410169</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Brasov</city>
        <zip>500051</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Bucharest</city>
        <zip>011461</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Bucharest</city>
        <zip>050159</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Leicester</city>
        <state>England</state>
        <zip>LE39QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Liverpool</city>
        <state>England</state>
        <zip>L7 8XP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>E1 2EF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>SW3 6NP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Wythenshawe</city>
        <state>England</state>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Bradford</city>
        <state>West Yorkshire</state>
        <zip>BD96RJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Japan</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>April 3, 2023</last_update_submitted>
  <last_update_submitted_qc>April 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspergillosis</mesh_term>
    <mesh_term>Pulmonary Aspergillosis</mesh_term>
    <mesh_term>Aspergillosis, Allergic Bronchopulmonary</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).</ipd_access_criteria>
    <ipd_url>https://vivli.org/</ipd_url>
  </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/NCT04442269
org study id: R668-ABPA-1923
secondary id: 2019-002619-24
nct id: NCT04442269
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of the study is to evaluate the efficacy of dupilumab on lung function
      in participants with Allergic Bronchopulmonary Aspergillosis (ABPA).

      The secondary objectives of the study are:

        -  To evaluate the effects of dupilumab on exacerbations in participants with ABPA

        -  To evaluate the effects of dupilumab on ABPA-related exacerbations

        -  To evaluate the effects of dupilumab on hospitalization/emergency department (ED)/urgent
           care visits in participants with ABPA

        -  To evaluate the effects of dupilumab on asthma control in participants with ABPA

        -  To evaluate the effects of dupilumab on health-related quality of life (HRQoL) in
           participants with ABPA

        -  To evaluate the effects of dupilumab on serum total immunoglobulin E (IgE) and
           Aspergillus-specific IgE concentrations

        -  To evaluate the effects of dupilumab on Fractional exhaled Nitric Oxide (FeNO) levels

        -  To evaluate safety and tolerability of dupilumab in participants with ABPA

        -  To evaluate dupilumab concentrations in serum and the incidence of anti-dupilumab
           antibodies in participants with ABPA
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) compared to placebo
time frame: At Week 24
measure: Annualized rate of severe respiratory exacerbations
time frame: Over the 24 to 52 Week Treatment Period
description: Defined as new onset of symptoms or clinical worsening of respiratory symptoms requiring systemic corticosteroid treatment for ≥3 consecutive days; for patients who are on maintenance systemic corticosteroids, at least double the dose of maintenance systemic corticosteroids for ≥3 consecutive days (with or without antibiotic therapy if indicated)
measure: Annualized rate of ABPA-related exacerbations
time frame: Over the 24 to 52 Week Treatment Period
description: Defined as severe respiratory exacerbations (as defined above) that are associated with a doubling of serum total Immunoglobulin E (IgE) from the prior pre-exacerbation value.
measure: Annualized rate of severe respiratory exacerbations requiring either hospitalization or observation for >24 hours in an ED/urgent care facility
time frame: Over the 24 to 52 Week Treatment Period
measure: Change from baseline in Asthma Control Questionnaire (ACQ)-5
time frame: Over the 24 to 52 Week Treatment Period
description: ACQ is completed by patient to measure both the adequacy of asthma control and change in asthma control, which occurs either spontaneously or as a result of treatment. The ACQ-5 score is the mean of the first 5 questions, between 0 (totally controlled) and 6 (severely uncontrolled). A higher score indicates lower asthma control. Patients with a score below 1.0 reflect adequately controlled asthma and patients with scores above 1.0 reflect inadequately controlled asthma. The optimal cut-point score of 1.50 should be used to be confident that a patient has inadequately controlled asthma.
measure: Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score
time frame: Over the 24 to 52 Week Treatment Period
description: SGRQ will be completed by the patient to measure and quantify health status in adult patients with chronic airflow limitation. Total score ranges from 0 to 100. Scores by dimension are calculated for three domains: Symptoms, Activity, and Impacts (Psychosocial). Lower score indicates better Quality of Life (QoL).
measure: Percentage of participants achieving a reduction in the SGRQ score of 4 points or greater from baseline
time frame: Up to 52 Weeks
description: SGRQ will be completed by the patient to measure and quantify health status in adult patients with chronic airflow limitation. Total score ranges from 0 to 100. Scores by dimension are calculated for three domains: Symptoms, Activity, and Impacts (Psychosocial). Lower score indicates better Quality of Life (QoL).
measure: Percent change from baseline in total IgE in serum
time frame: Over the 24 to 52 Week Treatment Period
measure: Percent change from baseline in A fumigatus-specific IgE in serum
time frame: Over the 24 to 52 Week Treatment Period
measure: Percent change from baseline in fractional exhaled nitric oxide (FeNO)
time frame: Over the 24 to 52 Week Treatment Period
measure: Absolute change from baseline in FeNO
time frame: Over the 24 to 52 Week Treatment Period
measure: Incidence of treatment-emergent adverse events (TEAEs) from baseline
time frame: Through the end of the 52 Week Treatment Period
measure: Incidence of treatment-emergent anti-drug antibody (ADA) responses and titer over time
time frame: Up to 64 Weeks
measure: Concentrations of functional dupilumab in serum by treatment regimen
time frame: Up to 64 Weeks
arm group label: dupilumab
arm group type: Experimental
description: Loading subcutaneous (SC) dose on day 1, followed by SC dose, every two weeks (Q2W)
arm group label: Placebo
arm group type: Experimental
description: Matching dupilumab without active substance
intervention type: Drug
intervention name: dupilumab
description: Single-use prefilled glass syringe administered by subcutaneous (SC) injection.
arm group label: dupilumab
other name: • DUPIXENT
other name: • REGN668
other name: • SAR231893
intervention type: Drug
intervention name: Placebo
description: Matching placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trial Management
role: Study Director
affiliation: Regeneron Pharmaceuticals
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country: Bulgaria
country: Canada
country: France
country: Germany
country: Hungary
country: Japan
country: Netherlands
country: Poland
country: Romania
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Aspergillosis
mesh term: Pulmonary Aspergillosis
mesh term: Aspergillosis, Allergic Bronchopulmonary
sharing ipd: Yes
ipd description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
ipd access criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
ipd url: https://vivli.org/