xml: <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/NCT06004037</url>
    </required_header>
    <id_info>
      <org_study_id>LCB01-0371-2004</org_study_id>
      <nct_id>NCT06004037</nct_id>
    </id_info>
    <brief_title>Study to Evaluate the Efficacy of Delpazolid as Add-on Therapy in Refractory Mycobacterium Abscessus Complex</brief_title>
    <official_title>A Phase 2a, Open-label, Single-arm, Multi-center Study to Evaluate the Efficacy and Safety of LCB01-0371 (Delpazolid) as Add-on Therapy in Patients With Refractory Mycobacterium Abscessus Complex Pulmonary Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>LegoChem Biosciences, Inc</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>LegoChem Biosciences, Inc</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>
        The purpose of this study is to evaluate the efficacy and safety of delpazolid add-on therapy&#xD;
        in Patients with Refractory Mycobacterium abscessus Complex Pulmonary disease&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Delpazolid, which demonstrates effects similar to other oxazolidinone-class drugs and has&#xD;
        confirmed good safety, aims to evaluate its efficacy in MABC-PD patients who are unresponsive&#xD;
        to guideline-based treatments&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">May 29, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 29, 2025</primary_completion_date>
    <phase>Phase 2</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline in the semi-quantitative scale (SQS)</measure>
      <time_frame>12 weeks</time_frame>
      <description>The SQS using liquid media and solid media will be scored a point of 1-7, with lower scores representing a reducing bacterial load.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in SQS</measure>
      <time_frame>4 weeks and 8 weeks</time_frame>
      <description>The SQS using liquid media and solid media will be scored a point of 1-7, with lower scores representing a reducing bacterial load.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sputum culture conversion rate</measure>
      <time_frame>12 weeks</time_frame>
      <description>neg culture x3( sputum conversion)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to culture conversion</measure>
      <time_frame>12 weeks</time_frame>
      <description>from the date of assignment to the first negative result.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to positivity in the liquid culture automated system (MGIT)</measure>
      <time_frame>12 weeks</time_frame>
      <description>time to detection of positive in MGIT system</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Negative sputum culture rate at each time point after baseline</measure>
      <time_frame>12 weeks</time_frame>
      <description>negative culture results in MGIT and solid media</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in the inflammatory marker</measure>
      <time_frame>12 weeks</time_frame>
      <description>erythrocyte sedimentation rate [ESR]) at each time point</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in the CT score</measure>
      <time_frame>12 weeks</time_frame>
      <description>The CT scan score will be transformed onto a scale of 0-42, with lower scores representing improved lung presentations.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life Questionnaire-Bronchiectasis</measure>
      <time_frame>12 weeks</time_frame>
      <description>The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Six-minute walk test</measure>
      <time_frame>12 weeks</time_frame>
      <description>Six-minute walk test</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Nontuberculous Mycobacterium Infection</condition>
    <condition>Mycobacterium Abscessus Infection</condition>
    <arm_group>
      <arm_group_label>delpazolid</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In addition to background therapy for MABC, patients will be given orally three tablets (400 mg/tablet) of LCB01-0371 for 12 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Delpazolid</intervention_name>
      <description>Three tablets (400 mg/tablet) of delpazolid will be orally administered once daily for 12 weeks.&#xD;
  After 3 months (12 weeks) of administration, if the investigator determines that there are clinical benefits, an additional extended treatment of up to 9 months (40 weeks) may be given, amounting to 1 year of treatment in total.</description>
      <arm_group_label>delpazolid</arm_group_label>
      <other_name>LCB01-0371</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pre-screening: Adults aged 19 years or above&#xD;
  &#xD;
            -  Pre-screening: Patients diagnosed with MABC (including subspecies abscessus, bolletii,&#xD;
               and massiliense) pulmonary disease in radiologic and microbiologic evaluations&#xD;
  &#xD;
            -  LCB01-0371 MIC ≤ 4 μg/mL for MABC&#xD;
  &#xD;
            -  Patients who continue to show positivity for MABC even after treatments based on the&#xD;
               guidelines of ATS/ERS/ESCMID/IDSA for at least 6 months prior to screening, and who&#xD;
               meet all of the following criteria:&#xD;
  &#xD;
                 1. Patients who have been confirmed positive at least once in the last sputum or&#xD;
                    bronchoscopy sample culture performed prior to screening&#xD;
  &#xD;
                 2. Patients who have not achieved culture conversion (at least 3 consecutive&#xD;
                    negative mycobacteria cultures in the sputum or bronchoscopy sample collected at&#xD;
                    an interval of at least 4 weeks) within 6 months prior to screening&#xD;
  &#xD;
            -  Patients who can voluntarily expectorate sputum at screening&#xD;
  &#xD;
            -  Patients with a life expectancy of 12 weeks or more&#xD;
  &#xD;
            -  Patients with adequate organ function who meet the following criteria:&#xD;
  &#xD;
                 1. Hemoglobin &gt; 9.0 g/dL (without transfusion within 2 weeks prior to measurement)&#xD;
  &#xD;
                 2. Absolute neutrophil count ≥ 1,500/µL (without administration of G-CSF within 2&#xD;
                    weeks prior to measurement)&#xD;
  &#xD;
                 3. Platelet ≥ 100,000/µL&#xD;
  &#xD;
                 4. Total bilirubin ≤ 1.5 × upper limit of normal (ULN)&#xD;
  &#xD;
                 5. Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 2.5 × ULN&#xD;
  &#xD;
                 6. Serum creatinine ≤ 1.5 × ULN or creatinine clearance &gt;30 mL/min (calculated with&#xD;
                    the Cockcroft-Gault formula)&#xD;
  &#xD;
            -  Patients who voluntarily provided a written consent to participate in the clinical&#xD;
               study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who cannot swallow the study drug tablet due to dysphagia, nasogastric tube&#xD;
               insertion, etc.&#xD;
  &#xD;
            -  Patients diagnosed with cystic fibrosis&#xD;
  &#xD;
            -  Patients who have received a lung transplant&#xD;
  &#xD;
            -  Patients with disseminated or extrapulmonary nontuberculous mycobacteria&#xD;
  &#xD;
            -  Patients with known active pulmonary tuberculosis&#xD;
  &#xD;
            -  Patients with atypical mycobacterial infections other than MABC&#xD;
  &#xD;
            -  Patients with an active pulmonary malignancy within 1 year prior to screening or&#xD;
               Patients with other malignancies that require chemotherapy or radiotherapy&#xD;
  &#xD;
            -  Patients who were administered linezolid for more than 2 weeks to treat MABC&#xD;
  &#xD;
            -  Patients with known HIV positivity or a suspected infection thereof or Patients with a&#xD;
               known active hepatitis B or C infection&#xD;
  &#xD;
            -  Patients who currently have a clinically significant cardiovascular disease&#xD;
  &#xD;
                 1. Patients with severe cardiac failure (New York Heart Association [NYHA] class&#xD;
                    III/IV) that occurred within 24 weeks prior to screening&#xD;
  &#xD;
                 2. Patients with pulmonary embolism or deep venous thrombosis that occurred within&#xD;
                    24 weeks prior to screening&#xD;
  &#xD;
            -  Patients whose multidrug therapy for treatment of MABC was changed within 4 weeks&#xD;
               prior to screening (Discontinuation, dose adjustment, change of administration route,&#xD;
               etc., are allowed.)&#xD;
  &#xD;
            -  Patients for whom the administration of contraindicated concomitant drugs that&#xD;
               correspond to the following cannot be discontinued during the clinical study or for&#xD;
               whom their administration is necessary&#xD;
  &#xD;
                 1. Administration of a new antibacterial agent for the prioritized treatment of&#xD;
                    atypical mycobacteria, especially MABC, other than background therapy&#xD;
  &#xD;
                 2. Monoamine oxidase inhibitors&#xD;
  &#xD;
                 3. Serotonin reuptake inhibitor or serotonin 5-HT1 receptor agonists&#xD;
  &#xD;
                 4. Meperidine or buspirone&#xD;
  &#xD;
                 5. Drugs that lower epilepsy threshold; tramadol, etc.&#xD;
  &#xD;
                 6. Other investigational products: If there is a history of administration within 30&#xD;
                    days prior to screening, it falls under the exclusion criteria.&#xD;
  &#xD;
            -  Pregnant or breastfeeding women and women of childbearing potential who do not agree&#xD;
               to practice appropriate contraceptive methods*:&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>NTM</keyword>
    <keyword>MABC</keyword>
    <keyword>MABC-PD</keyword>
    <keyword>rapid growers</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Mycobacterium Infections</mesh_term>
      <mesh_term>Mycobacterium Infections, Nontuberculous</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Delpazolid</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06004037
  org study id: LCB01-0371-2004
  nct id: NCT06004037
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the efficacy and safety of delpazolid add-on therapy
        in Patients with Refractory Mycobacterium abscessus Complex Pulmonary disease
  Delpazolid, which demonstrates effects similar to other oxazolidinone-class drugs and has
        confirmed good safety, aims to evaluate its efficacy in MABC-PD patients who are unresponsive
        to guideline-based treatments
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change from baseline in the semi-quantitative scale (SQS)
  time frame: 12 weeks
  description: The SQS using liquid media and solid media will be scored a point of 1-7, with lower scores representing a reducing bacterial load.
  measure: Change from baseline in SQS
  time frame: 4 weeks and 8 weeks
  description: The SQS using liquid media and solid media will be scored a point of 1-7, with lower scores representing a reducing bacterial load.
  measure: Sputum culture conversion rate
  time frame: 12 weeks
  description: neg culture x3( sputum conversion)
  measure: Time to culture conversion
  time frame: 12 weeks
  description: from the date of assignment to the first negative result.
  measure: Time to positivity in the liquid culture automated system (MGIT)
  time frame: 12 weeks
  description: time to detection of positive in MGIT system
  measure: Negative sputum culture rate at each time point after baseline
  time frame: 12 weeks
  description: negative culture results in MGIT and solid media
  measure: Change from baseline in the inflammatory marker
  time frame: 12 weeks
  description: erythrocyte sedimentation rate [ESR]) at each time point
  measure: Change from baseline in the CT score
  time frame: 12 weeks
  description: The CT scan score will be transformed onto a scale of 0-42, with lower scores representing improved lung presentations.
  measure: Quality of Life Questionnaire-Bronchiectasis
  time frame: 12 weeks
  description: The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.
  measure: Six-minute walk test
  time frame: 12 weeks
  description: Six-minute walk test
  arm group label: delpazolid
  arm group type: Experimental
  description: In addition to background therapy for MABC, patients will be given orally three tablets (400 mg/tablet) of LCB01-0371 for 12 weeks.
  intervention type: Drug
  intervention name: Delpazolid
  description: Three tablets (400 mg/tablet) of delpazolid will be orally administered once daily for 12 weeks.
  After 3 months (12 weeks) of administration, if the investigator determines that there are clinical benefits, an additional extended treatment of up to 9 months (40 weeks) may be given, amounting to 1 year of treatment in total.
  arm group label: delpazolid
  other name: LCB01-0371
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Mycobacterium Infections
  mesh term: Mycobacterium Infections, Nontuberculous
  mesh term: Delpazolid
  sharing ipd: No