<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/NCT03769662</url>
  </required_header>
  <id_info>
    <org_study_id>XT-150-1-0203</org_study_id>
    <nct_id>NCT03769662</nct_id>
  </id_info>
  <brief_title>Follow on Extension of XT-150-1-0201</brief_title>
  <official_title>XT-150-1-0201 Extension: Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xalud Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xalud Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      XT-150 safety and efficacy in severe osteoarthritic pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      XT-150-1-0201 Extension: Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the&#xD;
      Treatment of Osteoarthritic Pain.&#xD;
&#xD;
      Participants in this study will have been enrolled in the 0201 study and qualify for an&#xD;
      intra-articular injection of XT-150 into the osteoarthritic knee.&#xD;
&#xD;
      The study will assess XT-150 safety, tolerability, and efficacy in participants who received&#xD;
      placebo in the 0201 study, or have a second qualifying knee, or a second injection into the&#xD;
      same knee that was treated in 0201.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2019</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">October 30, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Open-label, single dose study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>6 months</time_frame>
    <description>Clinical Pathology, adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Verbal Numeric Rating Score</measure>
    <time_frame>6 months</time_frame>
    <description>Pain scale from 1 to 10, 10 being worst possible</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>KOOS</measure>
    <time_frame>6 months</time_frame>
    <description>Osteoarthritis pain, symptoms, impact on daily living, and quality of life. Subset scores are calculated such that 100% is normal function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory</measure>
    <time_frame>6 months</time_frame>
    <description>Pain and interference on daily living functions. Scales ranges from 0 to 10, with 10 being the worst</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Improvement</measure>
    <time_frame>6 months</time_frame>
    <description>0 - 7 Scale, 4 and below indicate no change or improvement. Over 4 indicates degrees of worsening</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>High dose from study XT-150-1-0201</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open label administration of the highest dose in the earlier study, in which all doses were well tolerated</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>XT-150</intervention_name>
    <description>IL-10 transgene DNA plasmid injected into the knee synovial capsule</description>
    <arm_group_label>High dose from study XT-150-1-0201</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Qualified and participated in clinical study XT-150-1-0201.&#xD;
&#xD;
               1. Participant was assigned to placebo, or&#xD;
&#xD;
               2. Participant elects to have XT-150 administered to the XT-150-untreated knee that&#xD;
                  qualified under XT-150-1-0201 criteria, or&#xD;
&#xD;
               3. Participant had inadequate pain relief and elects to receive a second injection&#xD;
                  to the same knee treated on clinical study XT-150-1-0201&#xD;
&#xD;
          2. Sufficiently severe OA of knee to require/have recommended knee replacement surgery or&#xD;
             be unsuitable for knee replacement surgery based on co-morbidities or orthopedic&#xD;
             considerations; be free of local or intra-articular infection.&#xD;
&#xD;
          3. Symptomatic disease because of osteoarthritis, defined as a Verbal Numerical Rating&#xD;
             Scale (VNRS) scores of a worst pain of at least 7 at any time during the preceding&#xD;
             week (based on scale of 0 to 10, with 10 representing &quot;pain as bad as you can&#xD;
             imagine&quot;).&#xD;
&#xD;
          4. Stable analgesic regimen during the 4 weeks prior to enrollment.&#xD;
&#xD;
          5. Inadequate pain relief (minimum ≥ 5 mean on Brief Pain Inventory-Severity Scale)&#xD;
             lasting more than 3 months.&#xD;
&#xD;
          6. In the judgment of the Investigator, acceptable general medical condition&#xD;
&#xD;
          7. Life expectancy &gt;6 months&#xD;
&#xD;
          8. Male participants who are heterosexually active and not surgically sterile must agree&#xD;
             to use effective contraception, including abstinence, for the duration of the study&#xD;
             and for 3 months after the study is completed.&#xD;
&#xD;
          9. Have suitable knee joint anatomy for intra-articular injection&#xD;
&#xD;
         10. Willing and able to return for the follow-up (FU) visits&#xD;
&#xD;
         11. Able to reliably provide pain assessment&#xD;
&#xD;
         12. Able to read and understand study instructions, and willing and able to comply with&#xD;
             all study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypersensitivity, allergy, or significant reaction to any ingredient of the study&#xD;
             drug, including double-stranded DNA, mannose, and sucrose&#xD;
&#xD;
          2. Scheduled knee replacement within 4 months; participant agrees not to schedule a knee&#xD;
             replacement appointment within 4 months of study treatment&#xD;
&#xD;
          3. History of rheumatoid arthritis of the knee or gout.&#xD;
&#xD;
          4. High peri-operative risks which in the judgment of the investigator preclude a safe&#xD;
             knee injection procedure (e.g., poorly controlled diabetes, cardiac inadequacy such as&#xD;
             NYHA class &gt; II, G4 glomerular filtration rate [eGFR &lt; 30 mL/min by Cockcroft-Gault])&#xD;
&#xD;
          5. Current treatment with immunosuppressive (systemic corticosteroid therapy [equivalent&#xD;
             to &gt;10mg/day prednisone] or other strong immunosuppressant)&#xD;
&#xD;
          6. History of immunosuppressive therapy; high-potency systemic steroids in the last 3&#xD;
             months.&#xD;
&#xD;
          7. Currently receiving systemic chemotherapy or radiation therapy for malignancy&#xD;
&#xD;
          8. Clinically significant hepatic disease as indicated by clinical laboratory results ≥3&#xD;
             times the upper limit of normal for any liver function test (e.g., aspartate&#xD;
             aminotransferase, alanine aminotransferase, lactate dehydrogenase)&#xD;
&#xD;
          9. Severe anemia (Grade 3; hemoglobin &lt;8.0 g/dL, &lt;4.9 mmol/L, &lt;80 g/L; transfusion&#xD;
             indicated), uncontrolled coagulopathy (Grade 1, prolonged activated partial&#xD;
             prothrombin time (aPTT) &gt; upper limit of normal (ULN) to 1.5xULN), or bleeding&#xD;
             diathesis, Grade 1 white cell counts (lymphocytes &lt;LLN - 800/mm3; &lt;LLN - 0.8 x 109 /L,&#xD;
             neutrophils &lt;LLN - 1500/mm3; &lt;LLN - 1.5 x 109 /L)&#xD;
&#xD;
         10. Significant neuropsychiatric conditions; dementia, major depression, or altered mental&#xD;
             state that in the opinion of the Investigator will interfere with study participation&#xD;
&#xD;
         11. Current treatment with systemic antibiotics or antivirals (EXCEPTION: topical&#xD;
             treatments)&#xD;
&#xD;
         12. Current treatment with anticoagulants, other than low-dose aspirin.&#xD;
&#xD;
         13. Known or suspected history of active alcohol or intravenous/oral drug abuse within 1&#xD;
             year before the screening visit&#xD;
&#xD;
         14. Women of child-bearing potential&#xD;
&#xD;
         15. Use of any investigational drug, other than XT-150, or device within 1 month before&#xD;
             enrollment or current participation in a trial that included intervention with a drug&#xD;
             or device; or currently participating in an investigational drug or device study.&#xD;
&#xD;
         16. Any condition that, in the opinion of the Principal Investigator, could compromise the&#xD;
             safety of the participant, the participant's ability to communicate with the study&#xD;
             staff, or the quality of the data&#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>Mark Rickman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Adelaide</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CMAX Clinical Research Pty Ltd in collaboration with University of Adelaide</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5005</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>January 14, 2020</last_update_submitted>
  <last_update_submitted_qc>January 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cytokines</keyword>
  <keyword>Anti-inflammatory</keyword>
  <keyword>Pain</keyword>
  <keyword>Inflammation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03769662
org study id: XT-150-1-0203
nct id: NCT03769662
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
XT-150 safety and efficacy in severe osteoarthritic pain.
XT-150-1-0201 Extension: Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the
      Treatment of Osteoarthritic Pain.

      Participants in this study will have been enrolled in the 0201 study and qualify for an
      intra-articular injection of XT-150 into the osteoarthritic knee.

      The study will assess XT-150 safety, tolerability, and efficacy in participants who received
      placebo in the 0201 study, or have a second qualifying knee, or a second injection into the
      same knee that was treated in 0201.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Open-label, single dose study
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Treatment-Emergent Adverse Events
time frame: 6 months
description: Clinical Pathology, adverse events
measure: Verbal Numeric Rating Score
time frame: 6 months
description: Pain scale from 1 to 10, 10 being worst possible
measure: KOOS
time frame: 6 months
description: Osteoarthritis pain, symptoms, impact on daily living, and quality of life. Subset scores are calculated such that 100% is normal function
measure: Brief Pain Inventory
time frame: 6 months
description: Pain and interference on daily living functions. Scales ranges from 0 to 10, with 10 being the worst
measure: Clinical Global Improvement
time frame: 6 months
description: 0 - 7 Scale, 4 and below indicate no change or improvement. Over 4 indicates degrees of worsening
arm group label: High dose from study XT-150-1-0201
arm group type: Experimental
description: Open label administration of the highest dose in the earlier study, in which all doses were well tolerated
intervention type: Biological
intervention name: XT-150
description: IL-10 transgene DNA plasmid injected into the knee synovial capsule
arm group label: High dose from study XT-150-1-0201
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Rickman, MD
role: Principal Investigator
affiliation: University of Adelaide
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Osteoarthritis, Knee
sharing ipd: No