<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/NCT03813160</url>
  </required_header>
  <id_info>
    <org_study_id>JBT101-DM-002</org_study_id>
    <nct_id>NCT03813160</nct_id>
  </id_info>
  <brief_title>Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis</brief_title>
  <acronym>DETERMINE</acronym>
  <official_title>A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corbus Pharmaceuticals Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corbus 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing&#xD;
      the efficacy and safety of lenabasum for the treatment of dermatomyositis. Approximately 150&#xD;
      subjects will be enrolled in this study at about 60 sites in North America, Europe, and Asia.&#xD;
      The planned duration of double-blind treatment with study drug is up to 52 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice&#xD;
      per day, or placebo twice per day in a 2:1:2 ratio. The primary efficacy outcome at Week 28&#xD;
      will compare lenabasum 20 mg BID to placebo the Total Improvement Score (TIS), which is a&#xD;
      weighted composite measure of improvement from baseline in six endpoints: Physician Global&#xD;
      Assessment of Disease Activity, Physician Assessment of Extramuscular Disease Activity,&#xD;
      Patient Global Assessment of Disease Activity, Health Assessment Questionnaire&#xD;
      (patient-reported disability), Manual Muscle Testing (MMT), and muscle enzymes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Actual">October 5, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <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>Efficacy of lenabasum 20 mg BID compared to placebo BID as measured by Total Improvement Score (TIS)</measure>
    <time_frame>Week 28</time_frame>
    <description>TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjects who achieve Definition of Improvement (DOI)</measure>
    <time_frame>Week 28</time_frame>
    <description>Defined as ≥ 3 of 6 core set measures improved by ≥ 20% (relative to Baseline) with no more than 2 core set measures worsening by ≥ 25% (MMT-8 may not decrease by ≥ 25% from baseline)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjects who improve by at least one category on the Investigator Global Assessment (IGA) scale of skin activity</measure>
    <time_frame>Week 28</time_frame>
    <description>The IGA is used by the investigator to score overall skin disease on a 0 to 4 scale; higher scores indicate greater skin disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score</measure>
    <time_frame>Week 28</time_frame>
    <description>CDASI is a validated outcome measure that systematically quantifies cutaneous DM disease activity and damage (Klein et al, 2007; Yassaee et al, 2010) Disease Activity Score is rated using three activity measures. The activity score ranges from 0 to 100. Higher scores indicate greater disease severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjects who achieve TIS &gt;= 40 (at least moderate improvement)</measure>
    <time_frame>Week 28</time_frame>
    <description>TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TIS in subjects receiving immunosuppressive therapies (including corticosteroids) for &gt; 1 year at Baseline</measure>
    <time_frame>Week 52</time_frame>
    <description>TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Forced vital capacity (FVC) absolute, in all subjects and those with interstitial lung disease (ILD) at Baseline.</measure>
    <time_frame>Week 28</time_frame>
    <description>ILD is defined as a history of fibrosis on chest x-ray, a history of ILD on CT of lungs, and/or FVC% predicted &lt;80% at Screening or Visit 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Forced vital capacity (FVC) percent predicted, in all subjects and those with interstitial lung disease (ILD) at Baseline.</measure>
    <time_frame>Week 28</time_frame>
    <description>ILD is defined as a history of fibrosis on chest x-ray, a history of ILD on CT of lungs, and/or FVC% predicted &lt;80% at Screening or Visit 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TIS at Visit 10</measure>
    <time_frame>Week 52</time_frame>
    <description>TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TIS, lenabasum 5 mg BID versus placebo</measure>
    <time_frame>Week 28</time_frame>
    <description>TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">176</enrollment>
  <condition>Dermatomyositis</condition>
  <arm_group>
    <arm_group_label>Lenabasum 20 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive lenabasum 20 mg twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lenabasum 5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive lenabasum 5 mg twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will receive placebo twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenabasum 20 mg</intervention_name>
    <description>oral capsule</description>
    <arm_group_label>Lenabasum 20 mg</arm_group_label>
    <other_name>JBT-101</other_name>
    <other_name>anabasum</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenabasum 5 mg</intervention_name>
    <description>oral capsule</description>
    <arm_group_label>Lenabasum 5 mg</arm_group_label>
    <other_name>JBT-101</other_name>
    <other_name>anabasum</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>oral capsule</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fulfill at least one of the following criteria for dermatomyositis:&#xD;
&#xD;
               1. Bohan and Peter criteria (Bohan and Peter, 1975a; Bohan and Peter 1975b)&#xD;
&#xD;
               2. ACR/EULAR criteria (Lundberg et al, 2017)&#xD;
&#xD;
          -  Disease activity/severity fulfills at least one of the following three criteria:&#xD;
&#xD;
               1. MDGA ≥ 3 cm (0 - 10 cm Visual Analog Scale [VAS]) and MMT-8 score ≤ 142 (out of&#xD;
                  150 total possible)&#xD;
&#xD;
               2. Sum of MDGA, PtGA and EMGA VAS scores is ≥ 10 cm (0-10 cm VAS for each)&#xD;
&#xD;
               3. MDGA ≥ 3 cm (0-10 cm VAS) and CDASI activity score of &gt; 14&#xD;
&#xD;
          -  Stable doses of immunosuppressive medications for DM as defined by:&#xD;
&#xD;
               1. Unchanged dose of oral corticosteroids ≤ 20 mg per day prednisone or equivalent&#xD;
                  for ≥ 4 weeks before Visit 1&#xD;
&#xD;
               2. Unchanged dose of immunosuppressive medications other than oral corticosteroids&#xD;
                  for ≥ 8 weeks before Screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable DM or DM with end-stage organ involvement at Screening or Visit 1&#xD;
&#xD;
          -  Significant diseases or conditions other than DM that may influence response to the&#xD;
             study drug or safety&#xD;
&#xD;
          -  Any of the following values for laboratory tests at Screening:&#xD;
&#xD;
               1. A positive pregnancy test (or at Visit 1)&#xD;
&#xD;
               2. Hemoglobin &lt; 9 g/dL in males and &lt; 8 g/dL in females&#xD;
&#xD;
               3. Neutrophils &lt; 1.0 × 10^9/L&#xD;
&#xD;
               4. Platelets &lt; 75 × 10^9/L&#xD;
&#xD;
               5. Creatinine clearance &lt; 50 mL/min on screening blood test, per the Modification of&#xD;
                  Diet in Renal Disease Study or in 24 hour urine creatine clearance measurement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Victoria P Werth, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chester V Oddis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh Department of Medicine/Division of Rheumatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HonorHealth Neurology</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Attune Health Center</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Division of Rheumatology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Denver Arthritis Clinic</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgetown University</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DelRicht Research</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Bayview Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota, Division of Rheumatic and Autoimmune Diseases</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University in St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh, Division of Rheumatology</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15261</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MUSC: Department of Neurology</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Neuromuscular Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumatic Disease Center</name>
      <address>
        <city>Glendale</city>
        <state>Wisconsin</state>
        <zip>53217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital &quot;Kaspela&quot; Rheumatology Clinic</name>
      <address>
        <city>Plovdiv</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT &quot;St. Ivan Rilski&quot;</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT</name>
      <address>
        <city>Stara Zagora</city>
        <zip>6000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of British Columbia, Dept. of Dermatology and Skin Science</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Revmatologicky ustav</name>
      <address>
        <city>Prague</city>
        <zip>12850</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite-Universitatsmedizin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Erlangen Nuremberg</name>
      <address>
        <city>Erlangen</city>
        <zip>D- 91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Goettingen</name>
      <address>
        <city>Göttingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Debrecen</name>
      <address>
        <city>Debrecen</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Policlinico-Vittorio Emanuele</name>
      <address>
        <city>Catania</city>
        <zip>95121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario A.Gemelli-IRCCS</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gunma University Hospital</name>
      <address>
        <city>Gunma</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital</name>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama City University Hospital</name>
      <address>
        <city>Kanagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyoto University Hospital</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Miyagi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nippon Medical School Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wakayama Medical Hospital</name>
      <address>
        <city>Wakayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inha University Hospital</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanyang University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KLIMED</name>
      <address>
        <city>Bialystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliniczny Szpital Wojewodzki Nr 1. im Fryderyka Chopina Klinika Dermatologii</name>
      <address>
        <city>Rzeszow</city>
        <zip>35-055</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KLIMED</name>
      <address>
        <city>Łomża</city>
        <zip>18-404</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vall d'Hebron General Hospital</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital 12 Octubre</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospital, Rheumatology Clinic</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Switzerland</country>
  </removed_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>August 15, 2022</last_update_submitted>
  <last_update_submitted_qc>August 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dermatomyositis</keyword>
  <keyword>cannabinoid receptor type 2 agonist</keyword>
  <keyword>JBT-101</keyword>
  <keyword>lenabasum</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatomyositis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dronabinol</mesh_term>
    <mesh_term>Lenabasum</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <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>January 13, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT03813160/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>May 26, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT03813160/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03813160
org study id: JBT101-DM-002
nct id: NCT03813160
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing
      the efficacy and safety of lenabasum for the treatment of dermatomyositis. Approximately 150
      subjects will be enrolled in this study at about 60 sites in North America, Europe, and Asia.
      The planned duration of double-blind treatment with study drug is up to 52 weeks.
Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice
      per day, or placebo twice per day in a 2:1:2 ratio. The primary efficacy outcome at Week 28
      will compare lenabasum 20 mg BID to placebo the Total Improvement Score (TIS), which is a
      weighted composite measure of improvement from baseline in six endpoints: Physician Global
      Assessment of Disease Activity, Physician Assessment of Extramuscular Disease Activity,
      Patient Global Assessment of Disease Activity, Health Assessment Questionnaire
      (patient-reported disability), Manual Muscle Testing (MMT), and muscle enzymes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Efficacy of lenabasum 20 mg BID compared to placebo BID as measured by Total Improvement Score (TIS)
time frame: Week 28
description: TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.
measure: Subjects who achieve Definition of Improvement (DOI)
time frame: Week 28
description: Defined as ≥ 3 of 6 core set measures improved by ≥ 20% (relative to Baseline) with no more than 2 core set measures worsening by ≥ 25% (MMT-8 may not decrease by ≥ 25% from baseline)
measure: Subjects who improve by at least one category on the Investigator Global Assessment (IGA) scale of skin activity
time frame: Week 28
description: The IGA is used by the investigator to score overall skin disease on a 0 to 4 scale; higher scores indicate greater skin disease.
measure: Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score
time frame: Week 28
description: CDASI is a validated outcome measure that systematically quantifies cutaneous DM disease activity and damage (Klein et al, 2007; Yassaee et al, 2010) Disease Activity Score is rated using three activity measures. The activity score ranges from 0 to 100. Higher scores indicate greater disease severity.
measure: Subjects who achieve TIS >= 40 (at least moderate improvement)
time frame: Week 28
description: TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.
measure: TIS in subjects receiving immunosuppressive therapies (including corticosteroids) for > 1 year at Baseline
time frame: Week 52
description: TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.
measure: Change in Forced vital capacity (FVC) absolute, in all subjects and those with interstitial lung disease (ILD) at Baseline.
time frame: Week 28
description: ILD is defined as a history of fibrosis on chest x-ray, a history of ILD on CT of lungs, and/or FVC% predicted <80% at Screening or Visit 1
measure: Change in Forced vital capacity (FVC) percent predicted, in all subjects and those with interstitial lung disease (ILD) at Baseline.
time frame: Week 28
description: ILD is defined as a history of fibrosis on chest x-ray, a history of ILD on CT of lungs, and/or FVC% predicted <80% at Screening or Visit 1
measure: TIS at Visit 10
time frame: Week 52
description: TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.
measure: TIS, lenabasum 5 mg BID versus placebo
time frame: Week 28
description: TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.
arm group label: Lenabasum 20 mg
arm group type: Experimental
description: Subjects will receive lenabasum 20 mg twice daily
arm group label: Lenabasum 5 mg
arm group type: Experimental
description: Subjects will receive lenabasum 5 mg twice daily
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will receive placebo twice daily
intervention type: Drug
intervention name: Lenabasum 20 mg
description: oral capsule
arm group label: Lenabasum 20 mg
other name: JBT-101
other name: anabasum
intervention type: Drug
intervention name: Lenabasum 5 mg
description: oral capsule
arm group label: Lenabasum 5 mg
other name: JBT-101
other name: anabasum
intervention type: Drug
intervention name: Placebo
description: oral capsule
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Victoria P Werth, MD
role: Principal Investigator
affiliation: University of Pennsylvania
last name: Chester V Oddis, MD
role: Principal Investigator
affiliation: University of Pittsburgh Department of Medicine/Division of Rheumatology
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country: Bulgaria
country: Canada
country: Czechia
country: Germany
country: Hungary
country: Italy
country: Japan
country: Korea, Republic of
country: Poland
country: Spain
country: Sweden
country: United Kingdom
country: United States
country: Switzerland
responsible party type: Sponsor
mesh term: Dermatomyositis
mesh term: Dronabinol
mesh term: Lenabasum
sharing ipd: Undecided
provided document: 
provided document: 