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/NCT05962788</url>
    </required_header>
    <id_info>
      <org_study_id>AUR-VCS-2020-04</org_study_id>
      <nct_id>NCT05962788</nct_id>
    </id_info>
    <brief_title>Long-Term Voclosporin Treatment in Adolescent Subjects With Lupus Nephritis</brief_title>
    <acronym>VOCAL-EXT</acronym>
    <official_title>An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Voclosporin in Adolescent Subjects With Lupus Nephritis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aurinia Pharmaceuticals Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Labcorp Corporation of America Holdings, Inc</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Aurinia Pharmaceuticals 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>
        The purpose of this study is to assess the long-term safety and tolerability of voclosporin&#xD;
        for up to an additional 12 months following completion of treatment in the AUR-VCS-2020-03&#xD;
        study (VOCAL) in adolescents with active lupus nephritis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a 12 month, prospective, multi-center, long-term, open-label extension study of&#xD;
        voclosporin in addition to background standard of care with mycophenolate mofetil (MMF) and&#xD;
        oral steroids.&#xD;
  &#xD;
        Subjects completing participation and treatment with study drug (voclosporin/placebo) of the&#xD;
        VOCAL Study (AUR-VCS-2020-03 ; NCT05288855) and meeting all eligibility criteria will&#xD;
        continue to receive open-label treatment with voclosporin for approximately 12 months giving&#xD;
        a total study treatment duration of 18 months from the start of VOCAL. Subjects completing&#xD;
        treatment in Group 2 of the VOCAL study who were receiving placebo will switch to receive&#xD;
        open-label voclosporin initially at the same number of capsules as was being administered at&#xD;
        the End of Study (EOS) Visit in VOCAL.&#xD;
  &#xD;
        All subjects will continue to receive background therapy of MMF and oral corticosteroids&#xD;
        starting at the same dose as at completion of the VOCAL study. When clinically indicated,&#xD;
        subjects are permitted to be titrated off oral corticosteroids.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">June 2026</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 of Treatment Emergent Adverse Events (TEAE)</measure>
      <time_frame>Per protocol from VOCAL-EXT Study Start to Study Completion plus a 30-day follow-up period</time_frame>
      <description>Incidence (subject counts and event counts) of TEAEs summarized by System Organ Class and Preferred Terms using MedDRA</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Renal Response</measure>
      <time_frame>Per protocol from Study Start to Study Completion plus a 30-day follow-up period</time_frame>
      <description>Proportion of subjects with renal response at Month 12 and 18, defined based on the following parameters:&#xD;
  urine protein creatinine ratio (UPCR) of ≤0.5 mg/mg, and&#xD;
  estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of &gt;20%, and&#xD;
  Received no rescue medication for lupus nephritis, and&#xD;
  Did not receive &gt;10 mg/day prednisone for ≥3 consecutive days or for ≥7 days in total prior to the renal response assessment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urine Protein Creatinine Ratio (UPCR)</measure>
      <time_frame>Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)</time_frame>
      <description>Proportion of subjects with UPCR of ≤0.7 mg/mg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Partial Renal Response</measure>
      <time_frame>Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)</time_frame>
      <description>Proportion of subjects in partial renal response as defined by ≥50% reduction from VOCAL baseline in UPCR</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Adolescent Lupus Nephritis</condition>
    <arm_group>
      <arm_group_label>Open Label</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All subjects will receive open label voclosporin initially at the same number of capsules as assigned at Week 24 (End of Study Visit) in AUR-VCS-2020-03 (VOCAL ; NCT05288855). At the Investigator's discretion and after consultation with the Medical Monitor, dose titration up or down in the study will be permitted up to the maximum dose that was studied in AUR-VCS-2020-03.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>voclosporin</intervention_name>
      <description>Subjects will receive 2 capsules (15.8 mg) BID (twice daily), 3 capsules (23.7 mg) BID or 4 capsules (31.6 mg) BID of voclosporin in addition to standard of care with mycophenolate mofetil (MMF) and steroids.</description>
      <arm_group_label>Open Label</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Written informed consent from parent/guardian before any study-specific procedures are&#xD;
               performed, if applicable per local regulations.&#xD;
  &#xD;
            -  Age-appropriate assent or informed consent from subject before any study-specific&#xD;
               procedures are performed.&#xD;
  &#xD;
            -  Subjects who have completed 24 weeks of treatment with study drug&#xD;
               (voclosporin/placebo) in the VOCAL study. Subjects who had a temporary interruption&#xD;
               and were able to successfully re-start study drug will be allowed to enroll after&#xD;
               Medical Monitor approval.&#xD;
  &#xD;
            -  In the opinion of the Investigator subject requires continued immunosuppressive&#xD;
               therapy.&#xD;
  &#xD;
            -  Subject is willing to continue to take oral MMF for the duration of the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Currently taking or known need for any of the following medications during the study:&#xD;
  &#xD;
                 -  Cholestyramine or other drugs that may interfere with enterohepatic recirculation&#xD;
                    of MMF&#xD;
  &#xD;
                 -  Calcineurin inhibitors (CNIs) (e.g., cyclosporin and tacrolimus)&#xD;
  &#xD;
                 -  Strong CYP3A4/5 inhibitors and inducers (e.g., ketoconazole, rifampin,&#xD;
                    itraconazole, clarithromycin)&#xD;
  &#xD;
            -  Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected&#xD;
               to require dialysis during the study period.&#xD;
  &#xD;
            -  A planned kidney transplant within study treatment period.&#xD;
  &#xD;
            -  Subjects with any medical condition which in the Investigator's judgement may be&#xD;
               associated with increased risk to the subject or may interfere with study assessments&#xD;
               or outcomes&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Antonia Coeshall</last_name>
      <phone>+44-7968-836321</phone>
      <email>acoeshall@auriniapharma.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Nemours Children's Health, Lake Nona Medical City</name>
        <address>
          <city>Orlando</city>
          <state>Florida</state>
          <zip>32827</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>voclosporin</keyword>
    <keyword>lupus nephritis</keyword>
    <keyword>calcineurin inhibitors</keyword>
    <keyword>adolescents</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nephritis</mesh_term>
      <mesh_term>Lupus Nephritis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05962788
  org study id: AUR-VCS-2020-04
  nct id: NCT05962788
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The purpose of this study is to assess the long-term safety and tolerability of voclosporin
        for up to an additional 12 months following completion of treatment in the AUR-VCS-2020-03
        study (VOCAL) in adolescents with active lupus nephritis.
  This is a 12 month, prospective, multi-center, long-term, open-label extension study of
        voclosporin in addition to background standard of care with mycophenolate mofetil (MMF) and
        oral steroids.
  
        Subjects completing participation and treatment with study drug (voclosporin/placebo) of the
        VOCAL Study (AUR-VCS-2020-03 ; NCT05288855) and meeting all eligibility criteria will
        continue to receive open-label treatment with voclosporin for approximately 12 months giving
        a total study treatment duration of 18 months from the start of VOCAL. Subjects completing
        treatment in Group 2 of the VOCAL study who were receiving placebo will switch to receive
        open-label voclosporin initially at the same number of capsules as was being administered at
        the End of Study (EOS) Visit in VOCAL.
  
        All subjects will continue to receive background therapy of MMF and oral corticosteroids
        starting at the same dose as at completion of the VOCAL study. When clinically indicated,
        subjects are permitted to be titrated off oral corticosteroids.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of Treatment Emergent Adverse Events (TEAE)
  time frame: Per protocol from VOCAL-EXT Study Start to Study Completion plus a 30-day follow-up period
  description: Incidence (subject counts and event counts) of TEAEs summarized by System Organ Class and Preferred Terms using MedDRA
  measure: Renal Response
  time frame: Per protocol from Study Start to Study Completion plus a 30-day follow-up period
  description: Proportion of subjects with renal response at Month 12 and 18, defined based on the following parameters:
  urine protein creatinine ratio (UPCR) of ≤0.5 mg/mg, and
  estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20%, and
  Received no rescue medication for lupus nephritis, and
  Did not receive >10 mg/day prednisone for ≥3 consecutive days or for ≥7 days in total prior to the renal response assessment
  measure: Urine Protein Creatinine Ratio (UPCR)
  time frame: Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)
  description: Proportion of subjects with UPCR of ≤0.7 mg/mg
  measure: Partial Renal Response
  time frame: Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)
  description: Proportion of subjects in partial renal response as defined by ≥50% reduction from VOCAL baseline in UPCR
  arm group label: Open Label
  arm group type: Experimental
  description: All subjects will receive open label voclosporin initially at the same number of capsules as assigned at Week 24 (End of Study Visit) in AUR-VCS-2020-03 (VOCAL ; NCT05288855). At the Investigator's discretion and after consultation with the Medical Monitor, dose titration up or down in the study will be permitted up to the maximum dose that was studied in AUR-VCS-2020-03.
  intervention type: Drug
  intervention name: voclosporin
  description: Subjects will receive 2 capsules (15.8 mg) BID (twice daily), 3 capsules (23.7 mg) BID or 4 capsules (31.6 mg) BID of voclosporin in addition to standard of care with mycophenolate mofetil (MMF) and steroids.
  arm group label: Open Label
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Antonia Coeshall
  phone: +44-7968-836321
  email: acoeshall@auriniapharma.com
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Nephritis
  mesh term: Lupus Nephritis
  sharing ipd: No