<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/NCT03231280</url>
  </required_header>
  <id_info>
    <org_study_id>TP-1803</org_study_id>
    <nct_id>NCT03231280</nct_id>
  </id_info>
  <brief_title>A Trial of a Single Delivery of SB-061 in Osteoarthritis of the Knee</brief_title>
  <acronym>MODIFY2</acronym>
  <official_title>A Placebo-controlled, Double-blind, Randomized Trial of a Single Intra-articular Delivery of SB-061 for the Treatment of Symptomatic Osteoarthritis of the Knee</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Symic OA Co.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nordic Bioscience A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Symic OA Co.</source>
  <oversight_info>
    <has_dmc>No</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 study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee.&#xD;
      Half of the patients will receive the agent via intra-articular injection and half will&#xD;
      receive a placebo injection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The treatment of pain associated with osteoarthritis may include periodic intra-articular&#xD;
      injections of corticosteroids or viscosupplements such as hyaluronic acid. SB-061 is&#xD;
      anticipated to relieve osteoarthritis pain by reinforcing the cartilage matrix and providing&#xD;
      a lubricating coating of the cartilage. Subjects will receive 1 intra-articular injection of&#xD;
      either SB-061 or placebo and be followed for 3 months to evaluate pain amelioration. Subjects&#xD;
      and Investigators are blinded to treatment allocation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2017</start_date>
  <completion_date type="Actual">March 27, 2018</completion_date>
  <primary_completion_date type="Actual">December 18, 2017</primary_completion_date>
  <phase>Phase 1/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>Pain</measure>
    <time_frame>Baseline, 4 weeks</time_frame>
    <description>Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain (A1) scores from baseline to 4 weeks post treatment will be compared between treatment and control groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>Through 4 weeks</time_frame>
    <description>A summary of Treatment-Emergent Adverse Events will be reported</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>Baseline, 4 weeks</time_frame>
    <description>Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) sub-scores scores related to pain from baseline to 4 weeks post treatment will be compared between treatment and control groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical function</measure>
    <time_frame>Baseline, 4 weeks</time_frame>
    <description>Change in Patient Global Assessement scores from baseline to 4 weeks post treatment will be compared between treatment and control groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>Baseline, 4 weeks</time_frame>
    <description>Change in Numeric Rating Scale (NRS) of pain from baseline to 4 weeks post treatment will be compared between treatment and control groups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>SB-061</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SB-061</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SB-061</intervention_name>
    <description>delivered via intra-articular injection</description>
    <arm_group_label>SB-061</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo delivered via intra-articular injection</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Femorotibial osteoarthritis of the knee&#xD;
&#xD;
          -  Radiological OA Kellgren-Lawrence grade 2 or 3&#xD;
&#xD;
          -  WOMAC Pain 1 score of the target knee of ≥4 and ≤ 9&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to medications or to intra-articular injections&#xD;
&#xD;
          -  Intra-articular delivery of corticosteroids or hyaluronic acid in the target knee&#xD;
             within 6 months of study&#xD;
&#xD;
          -  High dose systemic corticosteroid treatment of longer (&gt;14 days) duration w/in 6&#xD;
             months of study&#xD;
&#xD;
          -  Major surgery or arthroscopy of the target knee within year prior to study&#xD;
&#xD;
          -  Planned surgery in the target knee within the next 3 months&#xD;
&#xD;
          -  Concomitant inflammatory disease affecting either knee&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathan Bachtell, MD</last_name>
    <role>Study Director</role>
    <affiliation>Symic OA Co.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CCBR</name>
      <address>
        <city>Tallinn</city>
        <zip>10128</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medita Kliinik</name>
      <address>
        <city>Tartu</city>
        <zip>50107</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Estonia</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>April 17, 2018</last_update_submitted>
  <last_update_submitted_qc>April 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>knee</keyword>
  <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 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/NCT03231280
org study id: TP-1803
nct id: NCT03231280
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee.
      Half of the patients will receive the agent via intra-articular injection and half will
      receive a placebo injection.
The treatment of pain associated with osteoarthritis may include periodic intra-articular
      injections of corticosteroids or viscosupplements such as hyaluronic acid. SB-061 is
      anticipated to relieve osteoarthritis pain by reinforcing the cartilage matrix and providing
      a lubricating coating of the cartilage. Subjects will receive 1 intra-articular injection of
      either SB-061 or placebo and be followed for 3 months to evaluate pain amelioration. Subjects
      and Investigators are blinded to treatment allocation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain
time frame: Baseline, 4 weeks
description: Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain (A1) scores from baseline to 4 weeks post treatment will be compared between treatment and control groups.
measure: Incidence of Treatment-Emergent Adverse Events
time frame: Through 4 weeks
description: A summary of Treatment-Emergent Adverse Events will be reported
measure: Pain
time frame: Baseline, 4 weeks
description: Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) sub-scores scores related to pain from baseline to 4 weeks post treatment will be compared between treatment and control groups.
measure: Physical function
time frame: Baseline, 4 weeks
description: Change in Patient Global Assessement scores from baseline to 4 weeks post treatment will be compared between treatment and control groups.
measure: Pain
time frame: Baseline, 4 weeks
description: Change in Numeric Rating Scale (NRS) of pain from baseline to 4 weeks post treatment will be compared between treatment and control groups.
arm group label: SB-061
arm group type: Experimental
description: SB-061
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Device
intervention name: SB-061
description: delivered via intra-articular injection
arm group label: SB-061
intervention type: Other
intervention name: Placebo
description: Placebo delivered via intra-articular injection
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
last name: Nathan Bachtell, MD
role: Study Director
affiliation: Symic OA Co.
facility: 
facility: 
country: Estonia
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No