<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/NCT03275025</url>
  </required_header>
  <id_info>
    <org_study_id>YJ15-201</org_study_id>
    <nct_id>NCT03275025</nct_id>
  </id_info>
  <brief_title>A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid Arthritis</brief_title>
  <official_title>A Multicenter, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of YRA-1909 in Patients With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yungjin Pharm. Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yungjin Pharm. Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, randomized, double-blind phase2 study to evaluate the safety and&#xD;
      investigate the efficacy of YRA-1909 in Patients with Rheumatoid Arthritis who are on a&#xD;
      stable dose of Methotrexate(MTX) and who have an inadequate response to MTX(MTX-IR).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">November 19, 2019</completion_date>
  <primary_completion_date type="Actual">November 19, 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>American College of Rheumatology 20 (ACR20) response rate at Week 12</measure>
    <time_frame>Week 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Adverse Events</measure>
    <time_frame>Week 12</time_frame>
    <description>Incidence of all grade adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ACR20 Response at Week 4,8</measure>
    <time_frame>Week 4 and 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS) at Week 4,8 and 12</measure>
    <time_frame>Week 4,8 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACR 50, 70 Response at Week 4, 8 and 12</measure>
    <time_frame>Week 4, 8 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Percent Change From Baseline in the Swollen Joint Count(SJC) and Tender Joint Count (TJC) at Week 4, 8 and 12</measure>
    <time_frame>Week 4, 8 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 4, 8 and 12</measure>
    <time_frame>Week 4, 8 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Week 4, 8 and 12</measure>
    <time_frame>Weeks 4, 8 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change from Baseline in Assessment of participant's illness at Week 4, 8 and 12 by participants and investigator/sub-investigator</measure>
    <time_frame>Week 4, 8 and 12</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">116</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>YRA-1909 low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>YRA-1909 medium does</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>YRA-1909 high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>YRA-1909 Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>YRA-1909 low dose</intervention_name>
    <description>A low dose of YRA-1909; daily oral intake for 12 weeks</description>
    <arm_group_label>YRA-1909 low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>YRA-1909 mid dose</intervention_name>
    <description>A mid dose of YRA-1909; daily oral intake for 12 weeks</description>
    <arm_group_label>YRA-1909 medium does</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>YRA-1909 high dose</intervention_name>
    <description>A high dose of YRA-1909; daily oral intake for 12 weeks</description>
    <arm_group_label>YRA-1909 high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo dosing with daily oral intake for 12 weeks</description>
    <arm_group_label>YRA-1909 Placebo</arm_group_label>
    <arm_group_label>YRA-1909 low dose</arm_group_label>
    <arm_group_label>YRA-1909 medium does</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  19 Years to 80 Years&#xD;
&#xD;
          -  Subjects with onset RA classified by ACR/EULAR 2010 revised classification criteria at&#xD;
             least 12 weeks prior to screening&#xD;
&#xD;
          -  Subjects meet the ACR 1992 Revised Criteria for the Classification of Global&#xD;
             Functional Status in RA Class I, II or, III at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects meet the ACR 1992 Revised Criteria for the Classification of Global&#xD;
             Functional Status in RA Class Ⅳ at screening&#xD;
&#xD;
          -  Any of the following laboratory values at screening:&#xD;
&#xD;
               1. Patients with severe liver impairment (AST or ALT &gt; 2 times the upper limit of&#xD;
                  normal)&#xD;
&#xD;
               2. Patients with renal disease,immunodeficiency disease and peptic ulcer&#xD;
&#xD;
               3. Patients with pleural effusion and ascites&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>YeongWook Song, M.D.,Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Jongno-gu</state>
        <zip>110744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanllym University Medical Center</name>
      <address>
        <city>Anyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chungbuk National University Hospital</name>
      <address>
        <city>Chungju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kelmyung University Dongsan Medical Center</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chungnam National University Hospital</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyung Hee University Hospital at Gangdong</name>
      <address>
        <city>Gangdong</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hospital</name>
      <address>
        <city>Gwangju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonbuk National University Hospital</name>
      <address>
        <city>Jeonju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanyang University Seoul Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KyungHee University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul Metropolitan Goverment Seoul National Univeersity Boramae Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Suwon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 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>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03275025
org study id: YJ15-201
nct id: NCT03275025
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a multicenter, randomized, double-blind phase2 study to evaluate the safety and
      investigate the efficacy of YRA-1909 in Patients with Rheumatoid Arthritis who are on a
      stable dose of Methotrexate(MTX) and who have an inadequate response to MTX(MTX-IR).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: American College of Rheumatology 20 (ACR20) response rate at Week 12
time frame: Week 12
measure: Percentage of Participants With Adverse Events
time frame: Week 12
description: Incidence of all grade adverse events
measure: ACR20 Response at Week 4,8
time frame: Week 4 and 8
measure: Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS) at Week 4,8 and 12
time frame: Week 4,8 and 12
measure: ACR 50, 70 Response at Week 4, 8 and 12
time frame: Week 4, 8 and 12
measure: Mean Percent Change From Baseline in the Swollen Joint Count(SJC) and Tender Joint Count (TJC) at Week 4, 8 and 12
time frame: Week 4, 8 and 12
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 4, 8 and 12
time frame: Week 4, 8 and 12
measure: Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Week 4, 8 and 12
time frame: Weeks 4, 8 and 12
measure: Mean Change from Baseline in Assessment of participant's illness at Week 4, 8 and 12 by participants and investigator/sub-investigator
time frame: Week 4, 8 and 12
arm group label: YRA-1909 low dose
arm group type: Experimental
arm group label: YRA-1909 medium does
arm group type: Experimental
arm group label: YRA-1909 high dose
arm group type: Experimental
arm group label: YRA-1909 Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: YRA-1909 low dose
description: A low dose of YRA-1909; daily oral intake for 12 weeks
arm group label: YRA-1909 low dose
intervention type: Drug
intervention name: YRA-1909 mid dose
description: A mid dose of YRA-1909; daily oral intake for 12 weeks
arm group label: YRA-1909 medium does
intervention type: Drug
intervention name: YRA-1909 high dose
description: A high dose of YRA-1909; daily oral intake for 12 weeks
arm group label: YRA-1909 high dose
intervention type: Drug
intervention name: Placebo
description: Matching placebo dosing with daily oral intake for 12 weeks
arm group label: YRA-1909 Placebo
arm group label: YRA-1909 low dose
arm group label: YRA-1909 medium does
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
last name: YeongWook Song, M.D.,Ph.D.
role: Study Chair
affiliation: Seoul National University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: No