<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/NCT04487860</url>
  </required_header>
  <id_info>
    <org_study_id>AS012-20-01</org_study_id>
    <nct_id>NCT04487860</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo</brief_title>
  <official_title>A Phase II, Randomized, Double Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Pharmaceutical Industries Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Pharmaceutical Industries Limited</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>
      This is a randomized, double blind, placebo-controlled, phase II study. The study will be&#xD;
      performed as a multicenter, multinational study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 6, 2021</start_date>
  <completion_date type="Actual">February 22, 2023</completion_date>
  <primary_completion_date type="Actual">May 20, 2022</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change from baseline in Vitiligo Area Scoring Index score</measure>
    <time_frame>Week 24</time_frame>
    <description>Vitiligo Area Scoring Index score: numeric score that can range from 0 to 100, with higher VASI scores denoting poorer the disease state</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline in Vitiligo Extent Score</measure>
    <time_frame>Week 24</time_frame>
    <description>Natural distribution of vitiligo on body reﬂecting 6 different degrees of involvement (1 percent, 5 percent, 10 percent, 25 percent, 50 percent, 75 percent).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in Vitiligo Impact Patient scale</measure>
    <time_frame>Week 24</time_frame>
    <description>subjects will be asked to complete a questionnaire to assess the burden experienced by individuals affected. Summary scores range from 0 to 100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician's global assessment scores</measure>
    <time_frame>Week 52</time_frame>
    <description>Score 0=no involvement or Score 1=limited extent with at least 2-point reduction from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change, from baseline, in Dermatology Life Quality Index</measure>
    <time_frame>Week 52</time_frame>
    <description>The DLQI scores are based on the response from the patient. Each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0.&#xD;
The higher the score, the more quality of life is impaired OR lower scores indicate better quality of life.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">327</enrollment>
  <condition>Non-segmental Vitiligo</condition>
  <arm_group>
    <arm_group_label>AS012 dose regimen I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AS012 dose regimen II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AS012 dose regimen III</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AS012 dose regimen IV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AS012</intervention_name>
    <description>oral administration</description>
    <arm_group_label>AS012 dose regimen I</arm_group_label>
    <arm_group_label>AS012 dose regimen II</arm_group_label>
    <arm_group_label>AS012 dose regimen III</arm_group_label>
    <arm_group_label>AS012 dose regimen IV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>oral administration</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provide written informed consent.&#xD;
&#xD;
          2. Male or female ≥ 18 years of age at time of screening&#xD;
&#xD;
          3. Stable (without new patches ≥ 1 year) or unstable (with new patches for the last 1&#xD;
             year) vitiligo&#xD;
&#xD;
          4. VASI of ≥ 4 at screening and baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Segmental vitiligo, focal, or mixed Vitiligo&#xD;
&#xD;
          2. Subjects who have high risk of suicidality at the Screening assessment based on&#xD;
             Investigator's judgment&#xD;
&#xD;
          3. History of alcohol or drug abuse in the previous 2 years&#xD;
&#xD;
          4. Subjects who were submitted to melanocyte transfer&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sun Pharma Site 15</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 02</name>
      <address>
        <city>Bryant</city>
        <state>Arkansas</state>
        <zip>72022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 09</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 01</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33511.</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 06</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 04</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33175</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 05</name>
      <address>
        <city>Miramar</city>
        <state>Florida</state>
        <zip>33027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 10</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 14</name>
      <address>
        <city>West Lafayette</city>
        <state>Indiana</state>
        <zip>47906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 12</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 13</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 07</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 08</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 03</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 16</name>
      <address>
        <city>Pflugerville</city>
        <state>Texas</state>
        <zip>78660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 11</name>
      <address>
        <city>Mill Creek</city>
        <state>Washington</state>
        <zip>98012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 19</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujrat</state>
        <zip>380016</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 20</name>
      <address>
        <city>Gandhinagar</city>
        <state>Gujrat</state>
        <zip>382428</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 28</name>
      <address>
        <city>Rajkot</city>
        <state>Gujrat</state>
        <zip>360005</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 23</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560074</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun PharmaSite 24</name>
      <address>
        <city>Mysuru</city>
        <state>Karnataka</state>
        <zip>570001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 21</name>
      <address>
        <city>Aurangabad</city>
        <state>Maharashtra</state>
        <zip>431001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 25</name>
      <address>
        <city>Nashik</city>
        <state>Maharashtra</state>
        <zip>422101</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 26</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411005</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 17</name>
      <address>
        <city>Rajsamand</city>
        <state>Rajasthan,</state>
        <zip>313202</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 27</name>
      <address>
        <city>Lucknow</city>
        <state>Uttar Pradesh</state>
        <zip>226003</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 18</name>
      <address>
        <city>Lucknow</city>
        <state>Uttar Pradesh</state>
        <zip>226005</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Pharma Site 22</name>
      <address>
        <city>Chandigarh</city>
        <zip>160012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <disposition_first_submitted>March 9, 2023</disposition_first_submitted>
  <disposition_first_submitted_qc>March 23, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 27, 2023</disposition_first_posted>
  <last_update_submitted>March 23, 2023</last_update_submitted>
  <last_update_submitted_qc>March 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 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>Vitiligo</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT04487860
org study id: AS012-20-01
nct id: NCT04487860
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, double blind, placebo-controlled, phase II study. The study will be
      performed as a multicenter, multinational study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean change from baseline in Vitiligo Area Scoring Index score
time frame: Week 24
description: Vitiligo Area Scoring Index score: numeric score that can range from 0 to 100, with higher VASI scores denoting poorer the disease state
measure: Mean change from baseline in Vitiligo Extent Score
time frame: Week 24
description: Natural distribution of vitiligo on body reﬂecting 6 different degrees of involvement (1 percent, 5 percent, 10 percent, 25 percent, 50 percent, 75 percent).
measure: Mean change in Vitiligo Impact Patient scale
time frame: Week 24
description: subjects will be asked to complete a questionnaire to assess the burden experienced by individuals affected. Summary scores range from 0 to 100
measure: Physician's global assessment scores
time frame: Week 52
description: Score 0=no involvement or Score 1=limited extent with at least 2-point reduction from baseline
measure: Mean change, from baseline, in Dermatology Life Quality Index
time frame: Week 52
description: The DLQI scores are based on the response from the patient. Each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0.
The higher the score, the more quality of life is impaired OR lower scores indicate better quality of life.
arm group label: AS012 dose regimen I
arm group type: Experimental
description: Oral
arm group label: AS012 dose regimen II
arm group type: Experimental
description: Oral
arm group label: AS012 dose regimen III
arm group type: Experimental
description: Oral
arm group label: AS012 dose regimen IV
arm group type: Experimental
description: Oral
arm group label: Placebo
arm group type: Placebo Comparator
description: Oral
intervention type: Drug
intervention name: AS012
description: oral administration
arm group label: AS012 dose regimen I
arm group label: AS012 dose regimen II
arm group label: AS012 dose regimen III
arm group label: AS012 dose regimen IV
intervention type: Drug
intervention name: Placebo
description: oral administration
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
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country: India
country: United States
responsible party type: Sponsor
mesh term: Vitiligo
sharing ipd: No