Back to resultsA Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
Primary Purpose
Cervical Intraepithelial Neoplasia Grade 2/3
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BLS-ILB-E710c
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Intraepithelial Neoplasia Grade 2/3 focused on measuring Cervical Intraepithelian Neoplasia Grade 2/3, CIN 2/3, HPV
Eligibility 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)
Sites / Locations
- Korea University Ansan HospitalRecruiting
- CHA Bundang Medical Center, CHA UniversityRecruiting
- Catholic University of Korea, St. Vincent's HospitalRecruiting
- Catholic University of Korea, Uijeongbu St. Mary's HospitalRecruiting
- The Dongsan Medical Center of Keimyung HospitalRecruiting
- Gachon University Gil Medical CenterRecruiting
- Seoul National University HospitalRecruiting
- Yonsei Unversity Health SystemRecruiting
- University of Ulsan College of Medicine, Asan Medical CenterRecruiting
- Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
- Hallym University Medical CenterRecruiting
- Kwandong University College of Medicine Cheil HospitalRecruiting
- CHA Gangnam HospitalRecruiting
- Korea University Guro HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BLS-ILB-E710c
BLS-ILB-E710c-placebo
Arm 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)
Drug: BLS-ILB-E710c-placebo Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8)
Outcomes
Primary Outcome Measures
Regression rate
The rate of complete histopathological regression from baseline as compared to placebo
Secondary Outcome Measures
CIN classification
Change from baseline of CIN classification
Change of Reid's Colposcopic Index (RCI)
Change from baseline of RCI
Cytopathological classification
Change from baseline of cytopathological classification based on bethesda system
Expression rate of P16/Ki-67
Change from baseline as compared to placebo of the expression rate of P16/Ki-67
The number of CD8 positive cells in the cervix
Change from baseline as compared to placebo in the number of CD8 positive cells in the cervix
HPV 16 clearance rate
Change from baseline as compared to placebo in HPV 16 clearance rate
Change of RCI
Change of RCI based on the histopathological regression at Week 16
Full Information
NCT ID
NCT03274206
First Posted
September 5, 2017
Last Updated
February 6, 2020
Sponsor
BioLeaders Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03274206
Brief Title
A Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioLeaders Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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]
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia Grade 2/3
Keywords
Cervical Intraepithelian Neoplasia Grade 2/3, CIN 2/3, HPV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BLS-ILB-E710c
Arm Type
Experimental
Arm 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 Title
BLS-ILB-E710c-placebo
Arm Type
Placebo Comparator
Arm 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(s)
BLS-ILB-E710c
Intervention Description
BLS-ILB-E710c 250mg/capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
BLS-ILB-E710c-placebo
Primary Outcome Measure Information:
Title
Regression rate
Description
The rate of complete histopathological regression from baseline as compared to placebo
Time Frame
Baseline through Week 16
Secondary Outcome Measure Information:
Title
CIN classification
Description
Change from baseline of CIN classification
Time Frame
Baseline through Week 16
Title
Change of Reid's Colposcopic Index (RCI)
Description
Change from baseline of RCI
Time Frame
Baseline through Week 16 and Week 32
Title
Cytopathological classification
Description
Change from baseline of cytopathological classification based on bethesda system
Time Frame
Baseline through Week 16 and Week 32
Title
Expression rate of P16/Ki-67
Description
Change from baseline as compared to placebo of the expression rate of P16/Ki-67
Time Frame
Baseline through Week 16
Title
The number of CD8 positive cells in the cervix
Description
Change from baseline as compared to placebo in the number of CD8 positive cells in the cervix
Time Frame
Baseline through Week 16
Title
HPV 16 clearance rate
Description
Change from baseline as compared to placebo in HPV 16 clearance rate
Time Frame
Baseline through Week 16
Title
Change of RCI
Description
Change of RCI based on the histopathological regression at Week 16
Time Frame
Week 16 and Week 32
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Hyung Lee
Phone
+82-31-280-9622
Email
jhlee@bioleaders.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Kwan Lee, MD, PhD
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Ansan
State/Province
Geyonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nak-Woo Lee, MD, PhD
Phone
+82-2-2626-3142
Email
jklee38@kumc.or.kr
Facility Name
CHA Bundang Medical Center, CHA University
City
Seongnam si
State/Province
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Hun Song, MD, PhD
First Name & Middle Initial & Last Name & Degree
Suim Park
Email
suim1227@chamc.co.kr
Facility Name
Catholic University of Korea, St. Vincent's Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Jong Lee, MD, PhD
Phone
+82-31-249-8301
Email
orlando@catholic.ac.kr
Facility Name
Catholic University of Korea, Uijeongbu St. Mary's Hospital
City
Uijeongbu
State/Province
Gyeonggi-do
ZIP/Postal Code
11765
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Hui Kim, MD, PhD
Email
kjh@catholic.ac.kr
Facility Name
The Dongsan Medical Center of Keimyung Hospital
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi-Heum Cho, MD, PhD
Phone
+82-53-250-7518
Email
c0035@dsmc.or.kr
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Woo Shin, MD, PhD
Phone
+82-32-460-3823
Email
jwshin@gilhospital.com
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Weon Kim, MD, PhD
Phone
+82-2-2072-3511
First Name & Middle Initial & Last Name & Degree
Yeon-Jae Han
Facility Name
Yonsei Unversity Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Tae Kim, MD, PhD
Phone
+82-2-2228-2230
Email
ytkchoi@yuhs.ac
First Name & Middle Initial & Last Name & Degree
So Yeon Joo
Phone
+82-2-2228-5735
Email
70000ddal@yuhs.ac
Facility Name
University of Ulsan College of Medicine, Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong-Man Kim, MD, Ph.D
Phone
+82-2-3010-3640
First Name & Middle Initial & Last Name & Degree
Geum-hee Nah
Phone
+82-2-3010-3627
Facility Name
Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Young Hur, MD, Ph.D
Email
hursy@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Hee Sook Bae
Email
prigia83@naver.com
Facility Name
Hallym University Medical Center
City
Seoul
ZIP/Postal Code
07441
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Taek Park, MD, PhD
Phone
+82-2-829-5151
Email
parkst96@naver.com
Facility Name
Kwandong University College of Medicine Cheil Hospital
City
Seoul
ZIP/Postal Code
100-380
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Jin Kim, MD, PhD
Phone
+82-2-2000-7177
Email
kimonc@hotmail.com
Facility Name
CHA Gangnam Hospital
City
Seoul
ZIP/Postal Code
135-913
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seok Ju Seong, MD, PhD
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Kwan Lee, MD, PhD
Phone
+82-2626-3142
Email
jklee38@korea.ac.kr
First Name & Middle Initial & Last Name & Degree
Jae-Kwan Lee, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
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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