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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)

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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

Tracking Information
First Submitted Date  ICMJE September 5, 2017
First Posted Date  ICMJE September 6, 2017
Last Update Posted Date February 7, 2020
Actual Study Start Date  ICMJE August 30, 2017
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
Regression rate [ Time Frame: Baseline through Week 16 ]
The rate of complete histopathological regression from baseline as compared to placebo
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
  • CIN classification [ Time Frame: Baseline through Week 16 ]
    Change from baseline of CIN classification
  • Change of Reid's Colposcopic Index (RCI) [ Time Frame: Baseline through Week 16 and Week 32 ]
    Change from baseline of RCI
  • Cytopathological classification [ Time Frame: Baseline through Week 16 and Week 32 ]
    Change from baseline of cytopathological classification based on bethesda system
  • 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
  • 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
  • HPV 16 clearance rate [ Time Frame: Baseline through Week 16 ]
    Change from baseline as compared to placebo in HPV 16 clearance rate
  • Change of RCI [ Time Frame: Week 16 and Week 32 ]
    Change of RCI based on the histopathological regression at Week 16
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
Official Title  ICMJE A Phase 2b Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
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.
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]
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cervical Intraepithelial Neoplasia Grade 2/3
Intervention  ICMJE
  • Biological: BLS-ILB-E710c
    BLS-ILB-E710c 250mg/capsule
  • Drug: Placebo
    BLS-ILB-E710c-placebo
Study Arms  ICMJE
  • 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)
    Intervention: Biological: BLS-ILB-E710c
  • 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)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2017)
126
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jae Hyung Lee +82-31-280-9622 jhlee@bioleaders.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03274206
Other Study ID Numbers  ICMJE BLS-ILB-E710c-202
12591 ( Other Identifier: Ministry of Food and Drug Safety )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BioLeaders Corporation
Study Sponsor  ICMJE BioLeaders Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jae-Kwan Lee, MD, PhD Korea University Guro Hospital
PRS Account BioLeaders Corporation
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP