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

February 6, 2020 updated by: BioLeaders Corporation

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

126

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-712
        • Recruiting
        • The Dongsan Medical Center of Keimyung Hospital
        • Contact:
      • Incheon, Korea, Republic of, 21565
        • Recruiting
        • Gachon University Gil Medical Center
        • Contact:
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Jae-Weon Kim, MD, PhD
          • Phone Number: +82-2-2072-3511
        • Contact:
          • Yeon-Jae Han
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Yonsei Unversity Health System
        • Contact:
          • Young Tae Kim, MD, PhD
          • Phone Number: +82-2-2228-2230
          • Email: ytkchoi@yuhs.ac
        • Contact:
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • University of Ulsan College of Medicine, Asan Medical Center
        • Contact:
          • Yong-Man Kim, MD, Ph.D
          • Phone Number: +82-2-3010-3640
        • Contact:
          • Geum-hee Nah
          • Phone Number: +82-2-3010-3627
      • Seoul, Korea, Republic of, 06591
      • Seoul, Korea, Republic of, 07441
        • Recruiting
        • Hallym University Medical Center
        • Contact:
      • Seoul, Korea, Republic of, 100-380
        • Recruiting
        • Kwandong University College of Medicine Cheil Hospital
        • Contact:
      • Seoul, Korea, Republic of, 135-913
        • Recruiting
        • CHA Gangnam Hospital
        • Contact:
          • Seok Ju Seong, MD, PhD
      • Seoul, Korea, Republic of, 152-703
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
        • Principal Investigator:
          • Jae-Kwan Lee, MD, PhD
    • Geyonggi-do
      • Ansan, Geyonggi-do, Korea, Republic of, 15355
        • Recruiting
        • Korea University Ansan Hospital
        • Contact:
    • Gyeonggi-do
      • Seongnam si, Gyeonggi-do, Korea, Republic of, 13496
        • Recruiting
        • CHA Bundang Medical Center, CHA University
        • Contact:
          • Seung Hun Song, MD, PhD
        • Contact:
      • Suwon, Gyeonggi-do, Korea, Republic of, 16247
        • Recruiting
        • Catholic University of Korea, St. Vincent's Hospital
        • Contact:
      • Uijeongbu, Gyeonggi-do, Korea, Republic of, 11765
        • Recruiting
        • Catholic University of Korea, Uijeongbu St. Mary's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regression rate
Time Frame: Baseline through Week 16
The rate of complete histopathological regression from baseline as compared to placebo
Baseline through Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CIN classification
Time Frame: Baseline through Week 16
Change from baseline of CIN classification
Baseline through Week 16
Change of Reid's Colposcopic Index (RCI)
Time Frame: Baseline through Week 16 and Week 32
Change from baseline of RCI
Baseline through Week 16 and Week 32
Cytopathological classification
Time Frame: Baseline through Week 16 and Week 32
Change from baseline of cytopathological classification based on bethesda system
Baseline through Week 16 and Week 32
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
Baseline through Week 16
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
Baseline through Week 16
HPV 16 clearance rate
Time Frame: Baseline through Week 16
Change from baseline as compared to placebo in HPV 16 clearance rate
Baseline through Week 16
Change of RCI
Time Frame: Week 16 and Week 32
Change of RCI based on the histopathological regression at Week 16
Week 16 and Week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioLeaders Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2017

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

September 5, 2017

First Submitted That Met QC Criteria

September 5, 2017

First Posted (Actual)

September 6, 2017

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 6, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BLS-ILB-E710c-202
  • 12591 (Other Identifier: Ministry of Food and Drug Safety)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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