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/NCT05975983</url>
    </required_header>
    <id_info>
      <org_study_id>INS018-055-004</org_study_id>
      <nct_id>NCT05975983</nct_id>
    </id_info>
    <brief_title>Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis</brief_title>
    <official_title>A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>InSilico Medicine Hong Kong Limited</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>InSilico Medicine Hong Kong Limited</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>
        The goal of this clinical trial is to learn about INS018_055 in adults with Idiopathic&#xD;
        Pulmonary Fibrosis (IPF).&#xD;
  &#xD;
        The primary objective is to evaluate the safety and tolerability of INS018_055 orally&#xD;
        administered for up to 12 weeks in adult subjects with IPF compared to placebo.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2026</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2026</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>Percentage of patients who have at least 1 treatment-emergent adverse event (TEAE)</measure>
      <time_frame>Day 1 (Visit 2) up to Week 12 (End of Treatment (EOT))</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum plasma concentration (Cmax) of INS018_055 and metabolites (INS018_063 and INS018_095)</measure>
      <time_frame>Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time at which the maximum plasma concentration occurred (tmax) of INS018_055 and metabolites (INS018_063 and INS018_095)</measure>
      <time_frame>Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma concentration-time curve from time zero to dosing interval τ (AUC0-τ) of INS018_055 and metabolites (INS018_063 and INS018_095)</measure>
      <time_frame>Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma concentration-time curve from time zero to time with last measurable concentration t (AUC0-t) of INS018_055 and metabolites (INS018_063 and INS018_095)</measure>
      <time_frame>Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma concentration-time curve from time zero to infinity (∞) (AUC0-∞) of INS018_055 and metabolites (INS018_063 and INS018_095)</measure>
      <time_frame>Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Terminal elimination half-life (t1/2) of INS018_055 and metabolites (INS018_063 and INS018_095)</measure>
      <time_frame>Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Terminal elimination rate constant (λz) of INS018_055 and metabolites (INS018_063 and INS018_095)</measure>
      <time_frame>Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent clearance (CL/F) of INS018_055 and metabolites (INS018_063 and INS018_095)</measure>
      <time_frame>Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent volume of distribution (Vz/F) of INS018_055 and metabolites (INS018_063 and INS018_095)</measure>
      <time_frame>Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Accumulation ratio (Rac) for Cmax and AUC of INS018_055 and metabolites (INS018_063 and INS018_095)</measure>
      <time_frame>Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trough plasma concentration (Ctrough) of INS018_055 and metabolites (INS018_063 and INS018_095)</measure>
      <time_frame>Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relative change in Forced Vital Capacity (FVC) in mL</measure>
      <time_frame>Week 0/Visit 2 up to Week 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage change in FVC in mL</measure>
      <time_frame>Week 0/Visit 2 up to Week 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute and relative change in FVC % predicted</measure>
      <time_frame>Week 0/Visit 2 up to Week 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Diffusion Capacity of the lung for Carbon Monoxide (DLCO) % predicted</measure>
      <time_frame>Week 0/Visit 2 to Week 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Leicester Cough Questionnaire (LCQ)</measure>
      <time_frame>Week 0 to Week 4, 8 and 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in 6-Minute Walk Distance (6MWD) in meters</measure>
      <time_frame>Week 0 to Week 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of acute IPF exacerbations</measure>
      <time_frame>Week 0 up to Week 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of days hospitalized for acute IPF exacerbations</measure>
      <time_frame>Week 0 to up Week 12</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Idiopathic Pulmonary Fibrosis (IPF)</condition>
    <arm_group>
      <arm_group_label>INS018_055</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group 1: INS018_055 once daily up to 12 weeks, low dose&#xD;
  Group 2: INS018_055 twice daily up to 12 weeks, low dose&#xD;
  Group 3: INS018_055 once daily up to 12 weeks, high dose</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Group 4: Placebo once or twice daily up to 12 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>INS018_055</intervention_name>
      <description>Pharmaceutical formulation: Capsules&#xD;
  Mode of Administration: Oral</description>
      <arm_group_label>INS018_055</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Pharmaceutical formulation: Capsules&#xD;
  Mode of Administration: Oral</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female patients aged ≥40 years based on the date of the written informed&#xD;
               consent form&#xD;
  &#xD;
            2. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory&#xD;
               Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines&#xD;
  &#xD;
            3. In a stable condition and suitable for study participation based on the results of&#xD;
               medical history, physical examination, vital signs, 12-lead ECG, and laboratory&#xD;
               evaluation&#xD;
  &#xD;
            4. Subjects with background pirfenidone or nintedanib may be enrolled if their regimen of&#xD;
               antifibrotic therapy has been stable for ≥ 8 weeks prior to Visit 1&#xD;
  &#xD;
          Meeting all of the following criteria during the screening period:&#xD;
  &#xD;
            1. FVC ≥40% predicted of normal&#xD;
  &#xD;
            2. DLCO corrected for Hgb ≥25% and &lt;80% predicted of normal.&#xD;
  &#xD;
            3. forced expiratory volume in the first second/FVC (FEV1/FVC) ratio &gt;0.7 based on&#xD;
               pre-bronchodilator value&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Acute IPF exacerbation within 4 months prior to Visit 1 and/or Day 1, as determined by&#xD;
               the investigator&#xD;
  &#xD;
            2. Patients who are unwilling to refrain from smoking within 6 months prior to screening&#xD;
               and until the end of the study&#xD;
  &#xD;
            3. Female patients who are pregnant or nursing&#xD;
  &#xD;
            4. Abnormal ECG findings&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yichen Liu</last_name>
      <phone>+86 18817554306</phone>
      <email>Insilico-Clinicaltrial@insilico.ai</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Franz Espiritu</last_name>
      <email>franz@insilicomedicine.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Keck School of Medicine of USC</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90033</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Florida Lung Asthma and Sleep Specialist</name>
        <address>
          <city>Celebration</city>
          <state>Florida</state>
          <zip>34747-1818</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Southeastern Research Center</name>
        <address>
          <city>Winston-Salem</city>
          <state>North Carolina</state>
          <zip>27103-4007</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>University of Oklahoma Health Sciences Center (OUHSC)</name>
        <address>
          <city>Oklahoma City</city>
          <state>Oklahoma</state>
          <zip>73104-5417</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Bogan Sleep Consultants, LLC</name>
        <address>
          <city>Columbia</city>
          <state>South Carolina</state>
          <zip>29201-2953</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Univerity of Texas Southwestern Medical Center</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75235-6243</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Metroplex Pulmonary and Sleep Center</name>
        <address>
          <city>McKinney</city>
          <state>Texas</state>
          <zip>75069-1898</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Centers of America</name>
        <address>
          <city>McKinney</city>
          <state>Texas</state>
          <zip>75071</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>University of Utah, University Hospital</name>
        <address>
          <city>Salt Lake City</city>
          <state>Utah</state>
          <zip>84132</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 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 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pulmonary Fibrosis</keyword>
    <keyword>Idiopathic Pulmonary Fibrosis</keyword>
    <keyword>Fibrosis</keyword>
    <keyword>Pathologic Processes</keyword>
    <keyword>Lung Diseases, Interstitial</keyword>
    <keyword>Lung Diseases</keyword>
    <keyword>Respiratory Tract Diseases</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pulmonary Fibrosis</mesh_term>
      <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term>
      <mesh_term>Fibrosis</mesh_term>
    </condition_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/NCT05975983
  org study id: INS018-055-004
  nct id: NCT05975983
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The goal of this clinical trial is to learn about INS018_055 in adults with Idiopathic
        Pulmonary Fibrosis (IPF).
  
        The primary objective is to evaluate the safety and tolerability of INS018_055 orally
        administered for up to 12 weeks in adult subjects with IPF compared to placebo.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Percentage of patients who have at least 1 treatment-emergent adverse event (TEAE)
  time frame: Day 1 (Visit 2) up to Week 12 (End of Treatment (EOT))
  measure: Maximum plasma concentration (Cmax) of INS018_055 and metabolites (INS018_063 and INS018_095)
  time frame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
  measure: Time at which the maximum plasma concentration occurred (tmax) of INS018_055 and metabolites (INS018_063 and INS018_095)
  time frame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
  measure: Area under the plasma concentration-time curve from time zero to dosing interval τ (AUC0-τ) of INS018_055 and metabolites (INS018_063 and INS018_095)
  time frame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
  measure: Area under the plasma concentration-time curve from time zero to time with last measurable concentration t (AUC0-t) of INS018_055 and metabolites (INS018_063 and INS018_095)
  time frame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
  measure: Area under the plasma concentration-time curve from time zero to infinity (∞) (AUC0-∞) of INS018_055 and metabolites (INS018_063 and INS018_095)
  time frame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
  measure: Terminal elimination half-life (t1/2) of INS018_055 and metabolites (INS018_063 and INS018_095)
  time frame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
  measure: Terminal elimination rate constant (λz) of INS018_055 and metabolites (INS018_063 and INS018_095)
  time frame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
  measure: Apparent clearance (CL/F) of INS018_055 and metabolites (INS018_063 and INS018_095)
  time frame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
  measure: Apparent volume of distribution (Vz/F) of INS018_055 and metabolites (INS018_063 and INS018_095)
  time frame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
  measure: Accumulation ratio (Rac) for Cmax and AUC of INS018_055 and metabolites (INS018_063 and INS018_095)
  time frame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
  measure: Trough plasma concentration (Ctrough) of INS018_055 and metabolites (INS018_063 and INS018_095)
  time frame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
  measure: Relative change in Forced Vital Capacity (FVC) in mL
  time frame: Week 0/Visit 2 up to Week 12
  measure: Percentage change in FVC in mL
  time frame: Week 0/Visit 2 up to Week 12
  measure: Absolute and relative change in FVC % predicted
  time frame: Week 0/Visit 2 up to Week 12
  measure: Change in Diffusion Capacity of the lung for Carbon Monoxide (DLCO) % predicted
  time frame: Week 0/Visit 2 to Week 12
  measure: Change in Leicester Cough Questionnaire (LCQ)
  time frame: Week 0 to Week 4, 8 and 12
  measure: Change in 6-Minute Walk Distance (6MWD) in meters
  time frame: Week 0 to Week 12
  measure: Number of acute IPF exacerbations
  time frame: Week 0 up to Week 12
  measure: Number of days hospitalized for acute IPF exacerbations
  time frame: Week 0 to up Week 12
  arm group label: INS018_055
  arm group type: Experimental
  description: Group 1: INS018_055 once daily up to 12 weeks, low dose
  Group 2: INS018_055 twice daily up to 12 weeks, low dose
  Group 3: INS018_055 once daily up to 12 weeks, high dose
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Group 4: Placebo once or twice daily up to 12 weeks
  intervention type: Drug
  intervention name: INS018_055
  description: Pharmaceutical formulation: Capsules
  Mode of Administration: Oral
  arm group label: INS018_055
  intervention type: Drug
  intervention name: Placebo
  description: Pharmaceutical formulation: Capsules
  Mode of Administration: Oral
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yichen Liu
  phone: +86 18817554306
  email: Insilico-Clinicaltrial@insilico.ai
  last name: Franz Espiritu
  email: franz@insilicomedicine.com
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Pulmonary Fibrosis
  mesh term: Idiopathic Pulmonary Fibrosis
  mesh term: Fibrosis
  sharing ipd: No