xml: <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/NCT05979441</url>
    </required_header>
    <id_info>
      <org_study_id>ARGX-113-2011</org_study_id>
      <nct_id>NCT05979441</nct_id>
    </id_info>
    <brief_title>A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy</brief_title>
    <acronym>ALKIVIA+</acronym>
    <official_title>A Phase 3, Single-Arm, Multicenter, Open-label Extension of Study ARGX-113-2007 to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>argenx</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>argenx</source>
    <oversight_info>
      <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 measure the long-term safety and tolerability of efgartigimod&#xD;
        PH20 SC in adult participants with IIM who previously participated in ARGX-113-2007.&#xD;
        Secondary objectives include efficacy measures of efgartigimod PH20 SC in participants with&#xD;
        IIM.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2027</completion_date>
    <primary_completion_date type="Anticipated">September 2027</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 treatment-emergent adverse events and adverse event of special interest</measure>
      <time_frame>Up to 60 weeks</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Composite Glucocorticoid Toxicity Index (C-GTI) comprising the Aggregate Improvement Score (AIS) and the Cumulative Worsening Score (CWS)</measure>
      <time_frame>Up to 52 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prednisone dose reduction (average monthly dose)</measure>
      <time_frame>Up to 52 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants who discontinue corticosteroids</measure>
      <time_frame>Up to 52 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total improvement score (TIS)</measure>
      <time_frame>Up to 52 weeks</time_frame>
      <description>measured on a [0,100] scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of TIS responders (minimal, moderate, major)</measure>
      <time_frame>up to 52 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Individual core set measures (CSMs) of the TIS</measure>
      <time_frame>up to 52 weeks</time_frame>
      <description>measured on a [0,100] scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with clinically inactive disease</measure>
      <time_frame>up to 52 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with remission, defined as a clinically inactive disease for at least 24 weeks</measure>
      <time_frame>up to 52 weeks</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Myositis</condition>
    <arm_group>
      <arm_group_label>EFG PH20 SC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>participants receiving efgartigimod PH20 SC on top of background treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>EFG PH20 SC</intervention_name>
      <description>Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer</description>
      <arm_group_label>EFG PH20 SC</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Has completed trial ARGX-113-2007&#xD;
  &#xD;
            -  Being capable of providing signed informed consent and complying with protocol&#xD;
               requirements&#xD;
  &#xD;
            -  Agrees to use contraceptive measures consistent with local regulations and women of&#xD;
               childbearing potential must have a negative urine pregnancy test at baseline before&#xD;
               receiving the investigational medicinal product&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Intention to have major surgery during the study period; or any other medical&#xD;
               condition that has arisen since enrollment in study ARGX-113-2007, that in the&#xD;
               investigator's opinion, would confound the results of the study or put the participant&#xD;
               at undue risk&#xD;
  &#xD;
            -  Known hypersensitivity reaction to investigational medicinal product or 1 of its&#xD;
               excipients Development of any malignancy, either new or recurrent, other than basal&#xD;
               cell carcinoma of the skin, regardless of relatedness&#xD;
  &#xD;
            -  Permanent discontinuation of IMP in ARGX-113-2007, or met the permanent&#xD;
               discontinuation criteria at the rollover visit&#xD;
  &#xD;
            -  Diagnosis with a deselected subtype of myositis based on the analysis of the phase 2&#xD;
               stage data in ARGX-113-2007, unless the investigator determines that the participant&#xD;
               is benefiting from IMP as defined by a score of &quot;much better&quot; or &quot;moderately better&quot;&#xD;
               on the 'Clinical Global Impression of Change' and 'Patient Global&#xD;
  &#xD;
            -  Impression of Change' assessments for at least 12 weeks, and that enrolling in the&#xD;
               study is in the participant's best interest&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sabine Coppieters, MD</last_name>
      <phone>857-350-4834</phone>
      <email>Clinicaltrials@argenx.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 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>Myositis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979441
  org study id: ARGX-113-2011
  nct id: NCT05979441
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to measure the long-term safety and tolerability of efgartigimod
        PH20 SC in adult participants with IIM who previously participated in ARGX-113-2007.
        Secondary objectives include efficacy measures of efgartigimod PH20 SC in participants with
        IIM.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence treatment-emergent adverse events and adverse event of special interest
  time frame: Up to 60 weeks
  measure: Composite Glucocorticoid Toxicity Index (C-GTI) comprising the Aggregate Improvement Score (AIS) and the Cumulative Worsening Score (CWS)
  time frame: Up to 52 weeks
  measure: Prednisone dose reduction (average monthly dose)
  time frame: Up to 52 weeks
  measure: Proportion of participants who discontinue corticosteroids
  time frame: Up to 52 weeks
  measure: Total improvement score (TIS)
  time frame: Up to 52 weeks
  description: measured on a [0,100] scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
  measure: Proportion of TIS responders (minimal, moderate, major)
  time frame: up to 52 weeks
  measure: Individual core set measures (CSMs) of the TIS
  time frame: up to 52 weeks
  description: measured on a [0,100] scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
  measure: Percentage of participants with clinically inactive disease
  time frame: up to 52 weeks
  measure: Percentage of participants with remission, defined as a clinically inactive disease for at least 24 weeks
  time frame: up to 52 weeks
  arm group label: EFG PH20 SC
  arm group type: Experimental
  description: participants receiving efgartigimod PH20 SC on top of background treatment
  intervention type: Biological
  intervention name: EFG PH20 SC
  description: Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer
  arm group label: EFG PH20 SC
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sabine Coppieters, MD
  phone: 857-350-4834
  email: Clinicaltrials@argenx.com
  responsible party type: Sponsor
  mesh term: Myositis
  sharing ipd: Undecided