<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/NCT02999711</url>
  </required_header>
  <id_info>
    <org_study_id>R3500-AS-1619</org_study_id>
    <secondary_id>2016-002979-95</secondary_id>
    <nct_id>NCT02999711</nct_id>
  </id_info>
  <brief_title>Study of Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REGN3500 in Adults With Moderate Asthma</brief_title>
  <official_title>A Randomised, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Effects of Subcutaneously Administered REGN3500 in Adult Patients With Moderate Asthma</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>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of this study is to assess the safety and tolerability of multiple ascending&#xD;
      subcutaneous doses of REGN3500 to moderate asthmatics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 3, 2017</start_date>
  <completion_date type="Actual">September 10, 2018</completion_date>
  <primary_completion_date type="Actual">August 30, 2018</primary_completion_date>
  <phase>Phase 1</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of treatment emergent adverse events (TEAEs) after repeat subcutaneous administration</measure>
    <time_frame>Up to 36 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of TEAEs after repeat subcutaneous administration</measure>
    <time_frame>Up to 36 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The concentration-time profile of REGN3500 after repeat subcutaneous administration</measure>
    <time_frame>Up to 36 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity of REGN3500 assessed by measurement of anti-drug antibodies</measure>
    <time_frame>Up to 36 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change in total from baseline forced expiratory volume (FEV) at day 29</measure>
    <time_frame>Baseline to week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change of the average of the prior 7 days of FEV1 at day 29 compared to average daily FEV1 during the last 14 days of screening</measure>
    <time_frame>From -14 days screening to week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute change from baseline fractional exhaled nitric oxide (FeNO) at day 29</measure>
    <time_frame>Baseline to week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change from baseline FeNO at day 29</measure>
    <time_frame>Baseline to week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in biomarkers at day 29</measure>
    <time_frame>Baseline to week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change from baseline in biomarkers at day 29</measure>
    <time_frame>Baseline to week 4</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Asthma</condition>
  <condition>Moderate Asthma</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>REGN3500 low dose or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>REGN3500 medium dose or placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>REGN3500</intervention_name>
    <description>REGN3500 dose</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) of 18 to 32 kg/m2&#xD;
&#xD;
          -  A diagnosis of moderate asthma (according to GINA 2015) for a period of at least 2&#xD;
             years prior to screening.&#xD;
&#xD;
          -  Patient must use a stable medium daily dose level of inhaled corticosteroids (ICS) as&#xD;
             defined by GINA guidelines, ie, total daily dose of ICS &gt;400 μg and ≤800 μg/day of&#xD;
             budesonide or equivalent for at least 1 month prior to screening and during the study&#xD;
&#xD;
          -  A pre-bronchodilator forced expiratory volume in the first sec (FEV1) ≥60% and ≤90% of&#xD;
             the predicted normal values at screening and pre-dose at screening&#xD;
&#xD;
          -  A documented positive response to the reversibility test at the screening, defined as&#xD;
             improvement in FEV1 ≥12% and ≥200 mL over baseline after 400 μg salbutamol Pmdi&#xD;
&#xD;
          -  Willing and able to comply with clinic visits and study-related procedures&#xD;
&#xD;
          -  Provide signed informed consent.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant abnormal CBC, clinical chemistry, and urine analysis at&#xD;
             screening.&#xD;
&#xD;
          -  Treatment with an investigational drug within 8 weeks or within 5 half-lives (if&#xD;
             known), whichever is longer, prior to screening.&#xD;
&#xD;
          -  History of life-threatening asthma&#xD;
&#xD;
          -  Occurrence of asthma exacerbations or respiratory tract infections within 4 weeks&#xD;
             prior to screening.&#xD;
&#xD;
          -  Diagnosis of any other airway/pulmonary disease such as Chronic Obstructive Pulmonary&#xD;
             Disease (COPD) as defined by the Global Initiative for Chronic Obstructive Lung&#xD;
             Disease (GOLD) guidelines (GOLD 2016); or other lung diseases (eg, emphysema,&#xD;
             idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary&#xD;
             aspergillosis cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency or&#xD;
             restrictive lung disease).&#xD;
&#xD;
          -  Chronic or acute infection requiring treatment with systemic antibiotics, antivirals,&#xD;
             or antifungals within 1 month prior to screening.&#xD;
&#xD;
          -  Use of oral antibiotics/anti-infectives within 2 weeks prior to screening.&#xD;
&#xD;
          -  Known sensitivity to doxycycline or tetracyclines, or to any of the components of the&#xD;
             investigational product formulation.&#xD;
&#xD;
          -  Recent (within the previous 2 months) bacterial, protozoal, viral, or parasite&#xD;
             infection.&#xD;
&#xD;
          -  History of tuberculosis or systemic fungal diseases&#xD;
&#xD;
          -  Patients treated with a monoclonal antibody based therapy (such as an anti-IgE,&#xD;
             anti-IL-5), a biologic therapy or immunotherapy (subcutaneous immunotherapy [SCIT],&#xD;
             sublingual immunotherapy [SLIT], or oral immunotherapy [OIT]) in the previous 12 weeks&#xD;
             prior to screening and during the study&#xD;
&#xD;
        Note: Other protocol defined Inclusion/Exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trial Management</last_name>
    <role>Study Director</role>
    <affiliation>Regeneron Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regeneron Research Site</name>
      <address>
        <city>Belfast</city>
        <state>Northern Ireland</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Research Site</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Research Site</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Germany</country>
  </removed_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>December 10, 2018</last_update_submitted>
  <last_update_submitted_qc>December 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</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>Asthma</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02999711
org study id: R3500-AS-1619
secondary id: 2016-002979-95
nct id: NCT02999711
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Purpose of this study is to assess the safety and tolerability of multiple ascending
      subcutaneous doses of REGN3500 to moderate asthmatics.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of treatment emergent adverse events (TEAEs) after repeat subcutaneous administration
time frame: Up to 36 weeks
measure: Severity of TEAEs after repeat subcutaneous administration
time frame: Up to 36 weeks
measure: The concentration-time profile of REGN3500 after repeat subcutaneous administration
time frame: Up to 36 weeks
measure: Immunogenicity of REGN3500 assessed by measurement of anti-drug antibodies
time frame: Up to 36 weeks
measure: Percent change in total from baseline forced expiratory volume (FEV) at day 29
time frame: Baseline to week 4
measure: Percent change of the average of the prior 7 days of FEV1 at day 29 compared to average daily FEV1 during the last 14 days of screening
time frame: From -14 days screening to week 4
measure: Absolute change from baseline fractional exhaled nitric oxide (FeNO) at day 29
time frame: Baseline to week 4
measure: Percent change from baseline FeNO at day 29
time frame: Baseline to week 4
measure: Change from baseline in biomarkers at day 29
time frame: Baseline to week 4
measure: Percent change from baseline in biomarkers at day 29
time frame: Baseline to week 4
arm group label: Cohort 1
arm group type: Experimental
description: REGN3500 low dose or placebo
arm group label: Cohort 2
arm group type: Experimental
description: REGN3500 medium dose or placebo
intervention type: Drug
intervention name: REGN3500
description: REGN3500 dose
arm group label: Cohort 1
arm group label: Cohort 2
intervention type: Drug
intervention name: Placebo
description: Matching placebo
arm group label: Cohort 1
arm group label: Cohort 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Clinical Trial Management
role: Study Director
affiliation: Regeneron Pharmaceuticals
facility: 
facility: 
facility: 
country: United Kingdom
country: Germany
responsible party type: Sponsor
mesh term: Asthma