<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/NCT03274206</url>
  </required_header>
  <id_info>
    <org_study_id>BLS-ILB-E710c-202</org_study_id>
    <secondary_id>12591</secondary_id>
    <nct_id>NCT03274206</nct_id>
  </id_info>
  <brief_title>A Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)</brief_title>
  <official_title>A Phase 2b Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioLeaders Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BioLeaders Corporation</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 the efficacy and safety of the experimental drug, BLS-ILB-E710c, in&#xD;
      patients with Cervical Intraepithelial Neoplasia 2/3 (CIN2/3). 2/3 of participants will&#xD;
      receive the experimental drug, while 1/3 of participants will receive placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Outcome Measure:&#xD;
&#xD;
      Complete histopathological regression from baseline [Time Frame: Baseline through Week 16]&#xD;
&#xD;
      Secondary Outcome Measures:&#xD;
&#xD;
        -  Change from baseline of CIN classification [Time Frame: Baseline through Week 16]&#xD;
&#xD;
        -  Change from baseline of RCI [Time Frame: Baseline through Week 16 and Week 32]&#xD;
&#xD;
        -  Change from baseline of cytopathological classification based on bethesda system [Time&#xD;
           Frame: Baseline through Week 16 and Week 32]&#xD;
&#xD;
        -  Change from baseline as compared to placebo in the expression rate of P16/Ki-67 [Time&#xD;
           Frame: Baseline through Week 16]&#xD;
&#xD;
        -  Change from baseline as compared to placebo of the number of CD8 positive cells in the&#xD;
           cervical tissue [Time Frame: Baseline through Week 16]&#xD;
&#xD;
        -  Change from baseline as compared to placebo in HPV 16 clearance rate&#xD;
&#xD;
        -  Change of RCI based on the histopathological regression at Week 16 [Time Frame: Week 16&#xD;
           through Week 32]&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 30, 2017</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2020</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Regression rate</measure>
    <time_frame>Baseline through Week 16</time_frame>
    <description>The rate of complete histopathological regression from baseline as compared to placebo</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CIN classification</measure>
    <time_frame>Baseline through Week 16</time_frame>
    <description>Change from baseline of CIN classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Reid's Colposcopic Index (RCI)</measure>
    <time_frame>Baseline through Week 16 and Week 32</time_frame>
    <description>Change from baseline of RCI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytopathological classification</measure>
    <time_frame>Baseline through Week 16 and Week 32</time_frame>
    <description>Change from baseline of cytopathological classification based on bethesda system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expression rate of P16/Ki-67</measure>
    <time_frame>Baseline through Week 16</time_frame>
    <description>Change from baseline as compared to placebo of the expression rate of P16/Ki-67</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of CD8 positive cells in the cervix</measure>
    <time_frame>Baseline through Week 16</time_frame>
    <description>Change from baseline as compared to placebo in the number of CD8 positive cells in the cervix</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HPV 16 clearance rate</measure>
    <time_frame>Baseline through Week 16</time_frame>
    <description>Change from baseline as compared to placebo in HPV 16 clearance rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of RCI</measure>
    <time_frame>Week 16 and Week 32</time_frame>
    <description>Change of RCI based on the histopathological regression at Week 16</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">126</enrollment>
  <condition>Cervical Intraepithelial Neoplasia Grade 2/3</condition>
  <arm_group>
    <arm_group_label>BLS-ILB-E710c</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: BLS-ILB-E710c 1,000mg&#xD;
Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BLS-ILB-E710c-placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Drug: BLS-ILB-E710c-placebo&#xD;
Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BLS-ILB-E710c</intervention_name>
    <description>BLS-ILB-E710c 250mg/capsule</description>
    <arm_group_label>BLS-ILB-E710c</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>BLS-ILB-E710c-placebo</description>
    <arm_group_label>BLS-ILB-E710c-placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fertile female aged between 20 and 49&#xD;
&#xD;
          -  Subjects who are infected with HPV 16 type only or with HPV 16 type and any other&#xD;
             types listed below&#xD;
&#xD;
             1) low risk type of HPV, 2) HPV 16-related type&#xD;
&#xD;
          -  Subjects who are diagnosed as Cervical interaepithelial neoplasia 2/3 (CIN2/3) by&#xD;
             colposcopic biopsy within 6 weeks before enrollment&#xD;
&#xD;
          -  All lesions must be observable by colposcopy and CIN2 or higher lesion must be less&#xD;
             than 1/2 in the transformation zone area&#xD;
&#xD;
          -  Willing to use adequate contraception methods during the study period&#xD;
&#xD;
          -  Eligible based on screening test results&#xD;
&#xD;
          -  Normal electrocardiogram&#xD;
&#xD;
          -  Voluntarily signed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who are diagnosed with Carcinoma In Situ with microinvasion or suspicious&#xD;
             invation&#xD;
&#xD;
          -  Presence of adenocarcinoma or glandular lesion in the cervix&#xD;
&#xD;
          -  Subjects who are infected with HPV type 18-related type&#xD;
&#xD;
          -  Subjects with autoimmune disease&#xD;
&#xD;
          -  Current or prior treatment past 2 months with immunosuppressant therapies&#xD;
&#xD;
          -  Hypersensitive to the investigational drug&#xD;
&#xD;
          -  Subjects who currently have acute diseases that require medical attention&#xD;
&#xD;
          -  Participation in other studies involving investigational drug(s) or investigational&#xD;
             device(s) within 3 months&#xD;
&#xD;
          -  Currently having chronic pancreatitis or diagnosed with acute pancreatitis&#xD;
&#xD;
          -  Currently having underlying diseases including inflammatory intestinal diseases and&#xD;
             tumors, ulcer, bleeding or puncture in the gastrointestinal tract&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Subjects with active or inactive hepatitis, or infectious disease&#xD;
&#xD;
          -  History of HIV infection&#xD;
&#xD;
          -  History of therapeutic HPV vaccination&#xD;
&#xD;
          -  Subjects who require continuous use of antibiotics&#xD;
&#xD;
          -  Administration of blood product within 3 months before signing informed consent form&#xD;
&#xD;
          -  History of vaccination within 2 months before signing informed consent form (4 months&#xD;
             in case of live vaccine)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jae-Kwan Lee, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korea University Guro Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jae Hyung Lee</last_name>
    <phone>+82-31-280-9622</phone>
    <email>jhlee@bioleaders.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Korea University Ansan Hospital</name>
      <address>
        <city>Ansan</city>
        <state>Geyonggi-do</state>
        <zip>15355</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nak-Woo Lee, MD, PhD</last_name>
      <phone>+82-2-2626-3142</phone>
      <email>jklee38@kumc.or.kr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHA Bundang Medical Center, CHA University</name>
      <address>
        <city>Seongnam si</city>
        <state>Gyeonggi-do</state>
        <zip>13496</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Seung Hun Song, MD, PhD</last_name>
    </contact>
    <contact_backup>
      <last_name>Suim Park</last_name>
      <email>suim1227@chamc.co.kr</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Catholic University of Korea, St. Vincent's Hospital</name>
      <address>
        <city>Suwon</city>
        <state>Gyeonggi-do</state>
        <zip>16247</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sung Jong Lee, MD, PhD</last_name>
      <phone>+82-31-249-8301</phone>
      <email>orlando@catholic.ac.kr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Catholic University of Korea, Uijeongbu St. Mary's Hospital</name>
      <address>
        <city>Uijeongbu</city>
        <state>Gyeonggi-do</state>
        <zip>11765</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin Hui Kim, MD, PhD</last_name>
      <email>kjh@catholic.ac.kr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Dongsan Medical Center of Keimyung Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>700-712</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chi-Heum Cho, MD, PhD</last_name>
      <phone>+82-53-250-7518</phone>
      <email>c0035@dsmc.or.kr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <zip>21565</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin Woo Shin, MD, PhD</last_name>
      <phone>+82-32-460-3823</phone>
      <email>jwshin@gilhospital.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jae-Weon Kim, MD, PhD</last_name>
      <phone>+82-2-2072-3511</phone>
    </contact>
    <contact_backup>
      <last_name>Yeon-Jae Han</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Yonsei Unversity Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Young Tae Kim, MD, PhD</last_name>
      <phone>+82-2-2228-2230</phone>
      <email>ytkchoi@yuhs.ac</email>
    </contact>
    <contact_backup>
      <last_name>So Yeon Joo</last_name>
      <phone>+82-2-2228-5735</phone>
      <email>70000ddal@yuhs.ac</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>University of Ulsan College of Medicine, Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yong-Man Kim, MD, Ph.D</last_name>
      <phone>+82-2-3010-3640</phone>
    </contact>
    <contact_backup>
      <last_name>Geum-hee Nah</last_name>
      <phone>+82-2-3010-3627</phone>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Catholic University of Korea, Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Soo Young Hur, MD, Ph.D</last_name>
      <email>hursy@catholic.ac.kr</email>
    </contact>
    <contact_backup>
      <last_name>Hee Sook Bae</last_name>
      <email>prigia83@naver.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hallym University Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>07441</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sung Taek Park, MD, PhD</last_name>
      <phone>+82-2-829-5151</phone>
      <email>parkst96@naver.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kwandong University College of Medicine Cheil Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>100-380</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tae Jin Kim, MD, PhD</last_name>
      <phone>+82-2-2000-7177</phone>
      <email>kimonc@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHA Gangnam Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>135-913</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Seok Ju Seong, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Korea University Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>152-703</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jae-Kwan Lee, MD, PhD</last_name>
      <phone>+82-2626-3142</phone>
      <email>jklee38@korea.ac.kr</email>
    </contact>
    <investigator>
      <last_name>Jae-Kwan Lee, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>February 6, 2020</last_update_submitted>
  <last_update_submitted_qc>February 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cervical Intraepithelian Neoplasia Grade 2/3</keyword>
  <keyword>CIN 2/3</keyword>
  <keyword>HPV</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
    <mesh_term>Uterine Cervical Dysplasia</mesh_term>
  </condition_browse>
  <!-- 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/NCT03274206
org study id: BLS-ILB-E710c-202
secondary id: 12591
nct id: NCT03274206
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the efficacy and safety of the experimental drug, BLS-ILB-E710c, in
      patients with Cervical Intraepithelial Neoplasia 2/3 (CIN2/3). 2/3 of participants will
      receive the experimental drug, while 1/3 of participants will receive placebo.
Primary Outcome Measure:

      Complete histopathological regression from baseline [Time Frame: Baseline through Week 16]

      Secondary Outcome Measures:

        -  Change from baseline of CIN classification [Time Frame: Baseline through Week 16]

        -  Change from baseline of RCI [Time Frame: Baseline through Week 16 and Week 32]

        -  Change from baseline of cytopathological classification based on bethesda system [Time
           Frame: Baseline through Week 16 and Week 32]

        -  Change from baseline as compared to placebo in the expression rate of P16/Ki-67 [Time
           Frame: Baseline through Week 16]

        -  Change from baseline as compared to placebo of the number of CD8 positive cells in the
           cervical tissue [Time Frame: Baseline through Week 16]

        -  Change from baseline as compared to placebo in HPV 16 clearance rate

        -  Change of RCI based on the histopathological regression at Week 16 [Time Frame: Week 16
           through Week 32]
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Regression rate
time frame: Baseline through Week 16
description: The rate of complete histopathological regression from baseline as compared to placebo
measure: CIN classification
time frame: Baseline through Week 16
description: Change from baseline of CIN classification
measure: Change of Reid's Colposcopic Index (RCI)
time frame: Baseline through Week 16 and Week 32
description: Change from baseline of RCI
measure: Cytopathological classification
time frame: Baseline through Week 16 and Week 32
description: Change from baseline of cytopathological classification based on bethesda system
measure: Expression rate of P16/Ki-67
time frame: Baseline through Week 16
description: Change from baseline as compared to placebo of the expression rate of P16/Ki-67
measure: The number of CD8 positive cells in the cervix
time frame: Baseline through Week 16
description: Change from baseline as compared to placebo in the number of CD8 positive cells in the cervix
measure: HPV 16 clearance rate
time frame: Baseline through Week 16
description: Change from baseline as compared to placebo in HPV 16 clearance rate
measure: Change of RCI
time frame: Week 16 and Week 32
description: Change of RCI based on the histopathological regression at Week 16
arm group label: BLS-ILB-E710c
arm group type: Experimental
description: Drug: BLS-ILB-E710c 1,000mg
Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8)
arm group label: BLS-ILB-E710c-placebo
arm group type: Placebo Comparator
description: Drug: BLS-ILB-E710c-placebo
Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8)
intervention type: Biological
intervention name: BLS-ILB-E710c
description: BLS-ILB-E710c 250mg/capsule
arm group label: BLS-ILB-E710c
intervention type: Drug
intervention name: Placebo
description: BLS-ILB-E710c-placebo
arm group label: BLS-ILB-E710c-placebo
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 49 Years
healthy volunteers: No
last name: Jae-Kwan Lee, MD, PhD
role: Principal Investigator
affiliation: Korea University Guro Hospital
last name: Jae Hyung Lee
phone: +82-31-280-9622
email: jhlee@bioleaders.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Carcinoma in Situ
mesh term: Uterine Cervical Dysplasia