<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/NCT03240809</url>
  </required_header>
  <id_info>
    <org_study_id>V01-BROA-401</org_study_id>
    <nct_id>NCT03240809</nct_id>
  </id_info>
  <brief_title>An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects</brief_title>
  <official_title>An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects (6 to &lt; 18 Years Old) With Severe Plaque Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bausch Health Americas, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bausch Health Americas, 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>
      An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of&#xD;
      Brodalumab in Pediatric Subjects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of&#xD;
      Brodalumab in Pediatric Subjects (6 to &lt; 18 Years Old) With Severe Plaque Psoriasis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 24, 2020</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
  <phase>Phase 4</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>maximum observed concentration (Cmax)</measure>
    <time_frame>29 Days</time_frame>
    <description>maximum (or peak) serum concentration that drug achieves in the body after drug has been administrated and prior to the administration of a second dose</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>(ages 12 to &lt;18 years): 140 mg SC dose of brodalumab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>(ages 6 to &lt;12 years): 70 mg SC dose of brodalumab</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Brodalumab</intervention_name>
    <description>140 mg SC dose</description>
    <arm_group_label>Cohort 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Brodalumab</intervention_name>
    <description>70 mg SC dose</description>
    <arm_group_label>Cohort 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject's parent(s) or legally acceptable representative has provided informed&#xD;
             consent, using an Independent Ethics Committee (IEC) or Institutional Review Board&#xD;
             (IRB) approved Informed Consent Form (ICF), when the subject is legally too young to&#xD;
             provide informed consent and the subject has provided written assent based on local&#xD;
             regulations and/or guidelines prior to any study-specific activities/procedures being&#xD;
             initiated, or when the subject has any kind of condition that, in the opinion of the&#xD;
             investigator, may compromise the ability of the subject to give written informed&#xD;
             consent.&#xD;
&#xD;
          2. Males and females ages 6 to &lt;18 years of age, inclusive, at the time of screening&#xD;
&#xD;
          3. Subjects must have up-to-date immunizations according to the relevant local country&#xD;
             guideline. Subjects must not be scheduled to be vaccinated while on study.&#xD;
&#xD;
          4. Female subjects of childbearing potential must have a negative serum pregnancy test at&#xD;
             screening and a negative serum or urine pregnancy test at Baseline (Day 1). A female&#xD;
             of childbearing potential is defined as a female who is fertile, following menarche.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Received conventional systemic therapies or phototherapy for treatment of psoriasis&#xD;
             within the last 4 weeks. Topical corticosteroids are allowed.&#xD;
&#xD;
          2. Female subjects who have reached puberty and are sexually active and are unwilling to&#xD;
             use acceptable methods of effective birth control for the duration of the study and&#xD;
             continuing for 5 weeks after receiving the dose of study drug. Acceptable methods of&#xD;
             effective birth control include sexual abstinence (males and females); double barrier&#xD;
             method (male condom with spermicide in combination with one female barrier method&#xD;
             [diaphragm, cervical cap, or contraceptive sponge)]; or hormonal birth control; or&#xD;
             intra-uterine device.&#xD;
&#xD;
          3. Female subjects who are lactating/breastfeeding or who plan to breastfeed while on&#xD;
             study through 5 weeks after receiving the dose of study drug.&#xD;
&#xD;
          4. Female subjects with a positive pregnancy test.&#xD;
&#xD;
          5. Female subjects who are pregnant or planning to become pregnant while on study through&#xD;
             5 weeks after receiving the dose of study drug.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Varsha Bhatt</last_name>
    <role>Study Director</role>
    <affiliation>Bausch Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sandra Narain</last_name>
    <phone>908.242.8287</phone>
    <email>sandra.narain@bauschhealth.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Bausch Site 003</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Bausch Site 002</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Bausch Site 004</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Bausch Site 005</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Bausch Site 001</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 9, 2023</last_update_submitted>
  <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 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>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brodalumab</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_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/NCT03240809
org study id: V01-BROA-401
nct id: NCT03240809
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of
      Brodalumab in Pediatric Subjects
An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of
      Brodalumab in Pediatric Subjects (6 to < 18 Years Old) With Severe Plaque Psoriasis
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: maximum observed concentration (Cmax)
time frame: 29 Days
description: maximum (or peak) serum concentration that drug achieves in the body after drug has been administrated and prior to the administration of a second dose
arm group label: Cohort 1
arm group type: Experimental
description: (ages 12 to <18 years): 140 mg SC dose of brodalumab
arm group label: Cohort 2
arm group type: Experimental
description: (ages 6 to <12 years): 70 mg SC dose of brodalumab
intervention type: Biological
intervention name: Brodalumab
description: 140 mg SC dose
arm group label: Cohort 1
intervention type: Biological
intervention name: Brodalumab
description: 70 mg SC dose
arm group label: Cohort 2
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
last name: Varsha Bhatt
role: Study Director
affiliation: Bausch Health
last name: Sandra Narain
phone: 908.242.8287
email: sandra.narain@bauschhealth.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Brodalumab
mesh term: Antibodies, Monoclonal
sharing ipd: Undecided