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A Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03274206
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
BioLeaders Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Grade 2/3 Biological: BLS-ILB-E710c Drug: Placebo Phase 2

Detailed Description:

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]

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 30, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BLS-ILB-E710c
  • Drug: BLS-ILB-E710c 1,000mg
  • Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8)
Biological: BLS-ILB-E710c
BLS-ILB-E710c 250mg/capsule

Placebo Comparator: BLS-ILB-E710c-placebo
  • Drug: BLS-ILB-E710c-placebo
  • Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8)
Drug: Placebo
BLS-ILB-E710c-placebo




Primary Outcome Measures :
  1. Regression rate [ Time Frame: Baseline through Week 16 ]
    The rate of complete histopathological regression from baseline as compared to placebo


Secondary Outcome Measures :
  1. CIN classification [ Time Frame: Baseline through Week 16 ]
    Change from baseline of CIN classification

  2. Change of Reid's Colposcopic Index (RCI) [ Time Frame: Baseline through Week 16 and Week 32 ]
    Change from baseline of RCI

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

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

  5. The number of CD8 positive cells in the cervix [ Time Frame: Baseline through Week 16 ]
    Change from baseline as compared to placebo in the number of CD8 positive cells in the cervix

  6. HPV 16 clearance rate [ Time Frame: Baseline through Week 16 ]
    Change from baseline as compared to placebo in HPV 16 clearance rate

  7. Change of RCI [ Time Frame: Week 16 and Week 32 ]
    Change of RCI based on the histopathological regression at Week 16



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fertile female aged between 20 and 49
  • Subjects who are infected with HPV 16 type only or with HPV 16 type and any other types listed below

    1) low risk type of HPV, 2) HPV 16-related type

  • Subjects who are diagnosed as Cervical interaepithelial neoplasia 2/3 (CIN2/3) by colposcopic biopsy within 6 weeks before enrollment
  • All lesions must be observable by colposcopy and CIN2 or higher lesion must be less than 1/2 in the transformation zone area
  • Willing to use adequate contraception methods during the study period
  • Eligible based on screening test results
  • Normal electrocardiogram
  • Voluntarily signed informed consent form

Exclusion Criteria:

  • Subjects who are diagnosed with Carcinoma In Situ with microinvasion or suspicious invation
  • Presence of adenocarcinoma or glandular lesion in the cervix
  • Subjects who are infected with HPV type 18-related type
  • Subjects with autoimmune disease
  • Current or prior treatment past 2 months with immunosuppressant therapies
  • Hypersensitive to the investigational drug
  • Subjects who currently have acute diseases that require medical attention
  • Participation in other studies involving investigational drug(s) or investigational device(s) within 3 months
  • Currently having chronic pancreatitis or diagnosed with acute pancreatitis
  • Currently having underlying diseases including inflammatory intestinal diseases and tumors, ulcer, bleeding or puncture in the gastrointestinal tract
  • Pregnant or breastfeeding
  • Subjects with active or inactive hepatitis, or infectious disease
  • History of HIV infection
  • History of therapeutic HPV vaccination
  • Subjects who require continuous use of antibiotics
  • Administration of blood product within 3 months before signing informed consent form
  • History of vaccination within 2 months before signing informed consent form (4 months in case of live vaccine)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274206


Contacts
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Contact: Jae Hyung Lee +82-31-280-9622 jhlee@bioleaders.com

Locations
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Korea, Republic of
Korea University Ansan Hospital Recruiting
Ansan, Geyonggi-do, Korea, Republic of, 15355
Contact: Nak-Woo Lee, MD, PhD    +82-2-2626-3142    jklee38@kumc.or.kr   
CHA Bundang Medical Center, CHA University Recruiting
Seongnam si, Gyeonggi-do, Korea, Republic of, 13496
Contact: Seung Hun Song, MD, PhD         
Contact: Suim Park       suim1227@chamc.co.kr   
Catholic University of Korea, St. Vincent's Hospital Recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 16247
Contact: Sung Jong Lee, MD, PhD    +82-31-249-8301    orlando@catholic.ac.kr   
Catholic University of Korea, Uijeongbu St. Mary's Hospital Recruiting
Uijeongbu, Gyeonggi-do, Korea, Republic of, 11765
Contact: Jin Hui Kim, MD, PhD       kjh@catholic.ac.kr   
The Dongsan Medical Center of Keimyung Hospital Recruiting
Daegu, Korea, Republic of, 700-712
Contact: Chi-Heum Cho, MD, PhD    +82-53-250-7518    c0035@dsmc.or.kr   
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 21565
Contact: Jin Woo Shin, MD, PhD    +82-32-460-3823    jwshin@gilhospital.com   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Jae-Weon Kim, MD, PhD    +82-2-2072-3511      
Contact: Yeon-Jae Han         
Yonsei Unversity Health System Recruiting
Seoul, Korea, Republic of, 03722
Contact: Young Tae Kim, MD, PhD    +82-2-2228-2230    ytkchoi@yuhs.ac   
Contact: So Yeon Joo    +82-2-2228-5735    70000ddal@yuhs.ac   
University of Ulsan College of Medicine, Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Yong-Man Kim, MD, Ph.D    +82-2-3010-3640      
Contact: Geum-hee Nah    +82-2-3010-3627      
Catholic University of Korea, Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Contact: Soo Young Hur, MD, Ph.D       hursy@catholic.ac.kr   
Contact: Hee Sook Bae       prigia83@naver.com   
Hallym University Medical Center Recruiting
Seoul, Korea, Republic of, 07441
Contact: Sung Taek Park, MD, PhD    +82-2-829-5151    parkst96@naver.com   
Kwandong University College of Medicine Cheil Hospital Recruiting
Seoul, Korea, Republic of, 100-380
Contact: Tae Jin Kim, MD, PhD    +82-2-2000-7177    kimonc@hotmail.com   
CHA Gangnam Hospital Recruiting
Seoul, Korea, Republic of, 135-913
Contact: Seok Ju Seong, MD, PhD         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 152-703
Contact: Jae-Kwan Lee, MD, PhD    +82-2626-3142    jklee38@korea.ac.kr   
Principal Investigator: Jae-Kwan Lee, MD, PhD         
Sponsors and Collaborators
BioLeaders Corporation
Investigators
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Principal Investigator: Jae-Kwan Lee, MD, PhD Korea University Guro Hospital
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Responsible Party: BioLeaders Corporation
ClinicalTrials.gov Identifier: NCT03274206    
Other Study ID Numbers: BLS-ILB-E710c-202
12591 ( Other Identifier: Ministry of Food and Drug Safety )
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BioLeaders Corporation:
Cervical Intraepithelian Neoplasia Grade 2/3
CIN 2/3
HPV
Additional relevant MeSH terms:
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Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type