<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/NCT02980705</url>
  </required_header>
  <id_info>
    <org_study_id>CLR_16_22</org_study_id>
    <nct_id>NCT02980705</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of SUNPG1622</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis</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 2a study to evaluate the&#xD;
      efficacy and safety of SUNPG1622.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study terminated-Sponsor's decision&#xD;
  </why_stopped>
  <start_date type="Actual">November 6, 2017</start_date>
  <completion_date type="Actual">September 3, 2019</completion_date>
  <primary_completion_date type="Actual">February 21, 2019</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>Assessment of SpondyloArthritis International Society 20 Response Rates</measure>
    <time_frame>Week 24</time_frame>
    <description>Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]). The results for this endpoint is as per the Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates (Full Analysis Set).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of SpondyloArthritis International Society 20 Response Rates</measure>
    <time_frame>Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24</time_frame>
    <description>Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]). The following are the specific time points at which the outcome measure was assessed and for which data are presented : Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis</condition>
  <arm_group>
    <arm_group_label>SUNPG1622 I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SUNPG1622 I dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SUNPG1622 I dose</intervention_name>
    <description>Injection</description>
    <arm_group_label>SUNPG1622 I</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo dose</intervention_name>
    <description>Injection</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has provided informed written consent&#xD;
&#xD;
          -  Subject is ≥ 18 years of age at time of Screening&#xD;
&#xD;
          -  Subject must be on a stable dose of NSAID for ≥ 2 weeks prior to initiation of&#xD;
             investigational product&#xD;
&#xD;
          -  Subject has a negative test for TB within 4 weeks before initiating IMP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with known diagnosis of fibromyalgia or complex regional pain syndromes&#xD;
&#xD;
          -  Active uveitis or symptomatic inflammatory bowel disease requiring therapy at&#xD;
             screening&#xD;
&#xD;
          -  Radiographic evidence of total ankylosis of the spine&#xD;
&#xD;
          -  Subject has a planned surgical intervention between Baseline and the Week 24&#xD;
             evaluation for a pre-treatment condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>SPARC Site 1</name>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPARC site 3</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPARC site 3</name>
      <address>
        <city>Elbląg</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPARC site 2</name>
      <address>
        <city>A Coruña</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <results_first_submitted>September 16, 2020</results_first_submitted>
  <results_first_submitted_qc>February 12, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 21, 2021</results_first_posted>
  <last_update_submitted>October 29, 2021</last_update_submitted>
  <last_update_submitted_qc>October 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2021</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>Spondylitis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</mesh_term>
    <mesh_term>Axial Spondyloarthritis</mesh_term>
    <mesh_term>Non-Radiographic Axial Spondyloarthritis</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT02980705/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT02980705/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>It was planned that 90 subjects with active AS and 90 subjects with nr-axSpA would be enrolled to ensure completion of 180 subjects. One hundred and one subjects with active AS were actually enrolled and randomized and 82 subjects completed the study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>SUNPG1622 I</title>
          <description>SUNPG1622 I dose: Injection</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo dose: Injection</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>withdrew participation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SUNPG1622 I</title>
          <description>SUNPG1622 I dose: Injection</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo dose: Injection</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
            <count group_id="B2" value="51"/>
            <count group_id="B3" value="101"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Age, mean years (SD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.8" spread="9.18"/>
                    <measurement group_id="B2" value="39.1" spread="11.00"/>
                    <measurement group_id="B3" value="39.5" spread="10.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="98"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Assessment of SpondyloArthritis International Society 20 Response Rates</title>
        <description>Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]). The results for this endpoint is as per the Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates (Full Analysis Set).</description>
        <time_frame>Week 24</time_frame>
        <population>Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates at Week 24 by Cohort (Full Analysis Set)</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1622 I</title>
            <description>SUNPG1622 I dose: Injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo dose: Injection</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of SpondyloArthritis International Society 20 Response Rates</title>
          <description>Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]). The results for this endpoint is as per the Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates (Full Analysis Set).</description>
          <population>Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates at Week 24 by Cohort (Full Analysis Set)</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.00"/>
                    <measurement group_id="O2" value="80.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assessment of SpondyloArthritis International Society 20 Response Rates</title>
        <description>Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]). The following are the specific time points at which the outcome measure was assessed and for which data are presented : Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24.</description>
        <time_frame>Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24</time_frame>
        <population>ASAS20 Response Rates up to Week 24 by Cohort (Full Analysis Set)</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1622 I</title>
            <description>SUNPG1622 I dose: Injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo dose: Injection</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of SpondyloArthritis International Society 20 Response Rates</title>
          <description>Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]). The following are the specific time points at which the outcome measure was assessed and for which data are presented : Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24.</description>
          <population>ASAS20 Response Rates up to Week 24 by Cohort (Full Analysis Set)</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.00"/>
                    <measurement group_id="O2" value="83.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.00"/>
                    <measurement group_id="O2" value="59.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.00"/>
                    <measurement group_id="O2" value="57.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.00"/>
                    <measurement group_id="O2" value="46.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.00"/>
                    <measurement group_id="O2" value="36.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.00"/>
                    <measurement group_id="O2" value="22.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.33"/>
                    <measurement group_id="O2" value="20.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Week 72</time_frame>
      <desc>It is the approximate duration over which adverse event data were collected.&#xD;
Analysis of adverse events was performed in 3 Parts:&#xD;
Part 1: SUNPG1622→Placebo; from Day 1 to Week 24 Part 2: Treatment follow-up (SUNPG16221 dose injection); from Week 24 to Week 52 Part 3: Washout period between Week 52 and Week 72. In Part 3 of the study, all subjects underwent IMP washout and no subjects received SUNPG1622.</desc>
      <group_list>
        <group group_id="E1">
          <title>Part 1: SUNPG1622 or Placebo</title>
          <description>Group 1: SUNPG1622 or Placebo; From Baseline to Week 24.&#xD;
Safety results are provided per the following:&#xD;
Group 1: Subjects recieved either SUNPG1622 or Placebo</description>
        </group>
        <group group_id="E2">
          <title>Part 2: Treatment Follow-up (SUNPG16221 Dose Injection)</title>
          <description>Group 2: Treatment follow-up (SUNPG16221 dose injection); from Week 24 to Week 52.&#xD;
Safety results are provided per the following:&#xD;
Group 2: Subjects recieved SUNPG1622</description>
        </group>
        <group group_id="E3">
          <title>Part 3: Washout</title>
          <description>Group 3: Washout period between Week 52 and Week 72.&#xD;
Safety results are provided per the following:&#xD;
Group 3: washout period</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Crohn's disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Hyperplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Fibroadenoma of breast</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0.5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Glucose tolerance impaired</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal disorders</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Hyperplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Injection site joint erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Infections and infestations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Mudgal Kothekar</name_or_title>
      <organization>Sun Pharma Advanced Research Company Limited</organization>
      <phone>912266455645</phone>
      <email>clinical.trials@sparcmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02980705
org study id: CLR_16_22
nct id: NCT02980705
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the
      efficacy and safety of SUNPG1622.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Assessment of SpondyloArthritis International Society 20 Response Rates
time frame: Week 24
description: Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]). The results for this endpoint is as per the Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates (Full Analysis Set).
measure: Assessment of SpondyloArthritis International Society 20 Response Rates
time frame: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
description: Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]). The following are the specific time points at which the outcome measure was assessed and for which data are presented : Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24.
arm group label: SUNPG1622 I
arm group type: Experimental
description: SUNPG1622 I dose
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo dose
intervention type: Drug
intervention name: SUNPG1622 I dose
description: Injection
arm group label: SUNPG1622 I
intervention type: Drug
intervention name: Placebo dose
description: Injection
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Hungary
country: Poland
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing
mesh term: Axial Spondyloarthritis
mesh term: Non-Radiographic Axial Spondyloarthritis
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 