<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/NCT04506463</url>
  </required_header>
  <id_info>
    <org_study_id>CLR_17_17</org_study_id>
    <nct_id>NCT04506463</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis</brief_title>
  <official_title>A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Single-administration, Multiple-Dose Study to Demonstrate the Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Pharmaceutical Industries Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Moebius Medical Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nordic Bioscience Clinical Development (NBCD)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sun Pharmaceutical Industries Limited</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>
      This is a phase IIb, randomized, double-blind, placebo-controlled study to determine the&#xD;
      efficacy and safety of MM-II in subjects with symptomatic knee OA as compared to matching&#xD;
      placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 22, 2020</start_date>
  <completion_date type="Actual">August 10, 2022</completion_date>
  <primary_completion_date type="Actual">May 4, 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Western Ontario and McMaster Universities osteoarthritis index (WOMAC) A pain score</measure>
    <time_frame>Week 12</time_frame>
    <description>The pain score is based on a score of 0 to 4; the higher the score, the higher the amount of pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weekly average of daily knee pain scores by VAS</measure>
    <time_frame>Week 26</time_frame>
    <description>Knee pain will be assessed on a score of 0 to 100; the lower on the scale, the less the amount of knee pain experienced.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weekly average of daily global pain scores by VAS</measure>
    <time_frame>Week 26</time_frame>
    <description>Knee pain will be assessed on a score of 0 to 100; the lower on the scale, the less the amount of knee pain experienced.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">397</enrollment>
  <condition>Osteoarthritis of Knee</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MM-II 1 ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MM-II 3 ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MM-II 6 ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 4</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 1ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 5</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 3ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 6</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 6ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MM-II dose I</intervention_name>
    <description>Intra-articular injection</description>
    <arm_group_label>Arm A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MM-II dose II</intervention_name>
    <description>Intra-articular injection</description>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MM-II dose III</intervention_name>
    <description>Intra-articular injection</description>
    <arm_group_label>Arm C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Intra-articular injection</description>
    <arm_group_label>Arm 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Intra-articular injection</description>
    <arm_group_label>Arm 5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Intra-articular injection</description>
    <arm_group_label>Arm 6</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is able to provide written consent, understand study requirements, is prepared&#xD;
             to complete study procedures and is able to independently communicate meaningfully&#xD;
             with study personnel&#xD;
&#xD;
          2. Presence of index knee pain for at least 6 months prior to Screening&#xD;
&#xD;
          3. Men or women ≥ 40 years of age at the time of Screening&#xD;
&#xD;
          4. Radiographic evidence of knee Osteoarthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pain in the contralateral knee with a severity of ≥ 30 mm on a 100 mm VAS&#xD;
&#xD;
          2. Presence of ≥ 40 mm on a 100 mm VAS pain in any other joints&#xD;
&#xD;
          3. Concomitant moderate or large size synovial fluid effusion of the index knee at&#xD;
             Screening .&#xD;
&#xD;
          4. Known diagnosis of infection in the index knee in the past five years prior to&#xD;
             Screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sunpharma site no. 20</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 11</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85283</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 25</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 26</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 06</name>
      <address>
        <city>Stamford</city>
        <state>Connecticut</state>
        <zip>06905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 10</name>
      <address>
        <city>Lady Lake</city>
        <state>Florida</state>
        <zip>32159</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 08</name>
      <address>
        <city>Lake Worth</city>
        <state>Florida</state>
        <zip>33461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 13</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 22</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33145</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma Site no 27</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 12</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SunPharma Site no 23</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 05</name>
      <address>
        <city>Sunrise</city>
        <state>Florida</state>
        <zip>33351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 04</name>
      <address>
        <city>The Villages</city>
        <state>Florida</state>
        <zip>32159</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 18</name>
      <address>
        <city>Flossmoor</city>
        <state>Illinois</state>
        <zip>60422</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 07</name>
      <address>
        <city>Hazelwood</city>
        <state>Missouri</state>
        <zip>63042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 17</name>
      <address>
        <city>Williamsville</city>
        <state>New York</state>
        <zip>14221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 19</name>
      <address>
        <city>Edmond</city>
        <state>Oklahoma</state>
        <zip>73013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 09</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SunPharma Site No 24</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 21</name>
      <address>
        <city>Fort Mill</city>
        <state>South Carolina</state>
        <zip>29707</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 02</name>
      <address>
        <city>Gandrup</city>
        <zip>9362</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 01</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 03</name>
      <address>
        <city>Vejle</city>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunpharma site no. 14</name>
      <address>
        <city>Hong kong</city>
        <zip>00000</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Hong Kong</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <disposition_first_submitted>March 29, 2023</disposition_first_submitted>
  <disposition_first_submitted_qc>March 29, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">April 3, 2023</disposition_first_posted>
  <last_update_submitted>March 29, 2023</last_update_submitted>
  <last_update_submitted_qc>March 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 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>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</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/NCT04506463
org study id: CLR_17_17
nct id: NCT04506463
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
This is a phase IIb, randomized, double-blind, placebo-controlled study to determine the
      efficacy and safety of MM-II in subjects with symptomatic knee OA as compared to matching
      placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from Baseline in Western Ontario and McMaster Universities osteoarthritis index (WOMAC) A pain score
time frame: Week 12
description: The pain score is based on a score of 0 to 4; the higher the score, the higher the amount of pain.
measure: Weekly average of daily knee pain scores by VAS
time frame: Week 26
description: Knee pain will be assessed on a score of 0 to 100; the lower on the scale, the less the amount of knee pain experienced.
measure: Weekly average of daily global pain scores by VAS
time frame: Week 26
description: Knee pain will be assessed on a score of 0 to 100; the lower on the scale, the less the amount of knee pain experienced.
arm group label: Arm A
arm group type: Experimental
description: MM-II 1 ml
arm group label: Arm B
arm group type: Experimental
description: MM-II 3 ml
arm group label: Arm C
arm group type: Experimental
description: MM-II 6 ml
arm group label: Arm 4
arm group type: Placebo Comparator
description: Placebo 1ml
arm group label: Arm 5
arm group type: Placebo Comparator
description: Placebo 3ml
arm group label: Arm 6
arm group type: Placebo Comparator
description: Placebo 6ml
intervention type: Drug
intervention name: MM-II dose I
description: Intra-articular injection
arm group label: Arm A
intervention type: Drug
intervention name: MM-II dose II
description: Intra-articular injection
arm group label: Arm B
intervention type: Drug
intervention name: MM-II dose III
description: Intra-articular injection
arm group label: Arm C
intervention type: Drug
intervention name: Placebo
description: Intra-articular injection
arm group label: Arm 4
intervention type: Drug
intervention name: Placebo
description: Intra-articular injection
arm group label: Arm 5
intervention type: Drug
intervention name: Placebo
description: Intra-articular injection
arm group label: Arm 6
criteria: 
gender: All
minimum age: 40 Years
maximum age: 99 Years
healthy volunteers: No
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country: Denmark
country: Hong Kong
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No