<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/NCT03254667</url>
  </required_header>
  <id_info>
    <org_study_id>V01-BROA-402</org_study_id>
    <nct_id>NCT03254667</nct_id>
  </id_info>
  <brief_title>LTS of Siliq vs. Other Therapies Treating of Adults With Moderate-to-Severe Psoriasis</brief_title>
  <official_title>Prospective, Observational Study Brodalumab Compared With Other Therapies in the Treatment of Adults With Moderate-to-Severe Psoriasis Who Are Candidates for Systemic Therapy or Phototherapy in the Course of Actual Clinical Care</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, Observational Study to Assess the Long-Term Safety of Brodalumab Compared with&#xD;
      Other Therapies in the Treatment of Adults with Moderate-to-Severe Psoriasis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, Observational Study to Assess the Long-Term Safety of Brodalumab Compared with&#xD;
      Other Therapies in the Treatment of Adults with Moderate-to-Severe Psoriasis Who Are&#xD;
      Candidates for Systemic Therapy or Phototherapy in the Course of Actual Clinical Care&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">July 25, 2017</start_date>
  <completion_date type="Anticipated">November 2031</completion_date>
  <primary_completion_date type="Anticipated">November 10, 2030</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>8 Years</target_duration>
  <primary_outcome>
    <measure>Assess the incidence of malignancy</measure>
    <time_frame>8 years</time_frame>
    <description>Assess the incidence of malignancy, excluding non-melanoma skin cancer (NMSC), in adult psoriasis subjects exposed to brodalumab in the course of actual clinical care compared to non-IL-17-inhibitor biologic medications used to treat psoriasis.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">3500</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Brodalumad exposed</arm_group_label>
    <description>1500 subjects exposes to brodalumab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator Subjects</arm_group_label>
    <description>2000 comparator subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Brodalumab</intervention_name>
    <description>Brodalumab</description>
    <arm_group_label>Brodalumad exposed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Comparator Drug (non-biologic IL-17 inhibitors)</intervention_name>
    <description>Comparator subjects treated with non-biologic IL-17 inhibitors</description>
    <arm_group_label>Comparator Subjects</arm_group_label>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Neutrophil count&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Study population consisting of 1500 subjects treated with Brodalumab, and 2000 comparator&#xD;
        subjects being treated with a non-biologic IL-17 inhibitor drug.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis and main criteria for inclusion: a subject must have moderate to severe&#xD;
             psoriasis diagnosed by a dermatologist&#xD;
&#xD;
          2. Must be at least 18 years of age or older&#xD;
&#xD;
          3. Started on or switched to a systemic psoriasis treatment within the previous 12&#xD;
             months. FDA-approved biologic treatments and select non-biologic treatments (eg,&#xD;
             methotrexate, cyclosporine, or apremilast only) are permitted.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The subject is unable or unwilling to provide informed consent to participate in the&#xD;
             registry.&#xD;
&#xD;
          2. The subject is participating or planning to participate in a clinical trial with a&#xD;
             non-marketed or marketed investigational drug (i.e. Phase I-IV drug trial).&#xD;
&#xD;
          3. The subject is restarting the eligible medication less than 12 months since receiving&#xD;
             the last dose.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Anya Loncaric</last_name>
    <role>Study Director</role>
    <affiliation>Bausch Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Registry</name>
      <address>
        <city>Bridgewater</city>
        <state>New Jersey</state>
        <zip>08807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 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>
  </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/NCT03254667
org study id: V01-BROA-402
nct id: NCT03254667
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Prospective, Observational Study to Assess the Long-Term Safety of Brodalumab Compared with
      Other Therapies in the Treatment of Adults with Moderate-to-Severe Psoriasis
Prospective, Observational Study to Assess the Long-Term Safety of Brodalumab Compared with
      Other Therapies in the Treatment of Adults with Moderate-to-Severe Psoriasis Who Are
      Candidates for Systemic Therapy or Phototherapy in the Course of Actual Clinical Care
observational model: Cohort
time perspective: Prospective
measure: Assess the incidence of malignancy
time frame: 8 years
description: Assess the incidence of malignancy, excluding non-melanoma skin cancer (NMSC), in adult psoriasis subjects exposed to brodalumab in the course of actual clinical care compared to non-IL-17-inhibitor biologic medications used to treat psoriasis.
arm group label: Brodalumad exposed
description: 1500 subjects exposes to brodalumab
arm group label: Comparator Subjects
description: 2000 comparator subjects
intervention type: Biological
intervention name: Brodalumab
description: Brodalumab
arm group label: Brodalumad exposed
intervention type: Drug
intervention name: Comparator Drug (non-biologic IL-17 inhibitors)
description: Comparator subjects treated with non-biologic IL-17 inhibitors
arm group label: Comparator Subjects
Neutrophil count
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
last name: Anya Loncaric
role: Study Director
affiliation: Bausch Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Brodalumab
sharing ipd: Undecided