Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 12591 | Other Identifier | Ministry of Food and Drug Safety |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLS-ILB-E710c | Experimental |
|
|
| BLS-ILB-E710c-placebo | Placebo Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLS-ILB-E710c | Biological | BLS-ILB-E710c 250mg/capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Regression rate | The rate of complete histopathological regression from baseline as compared to placebo | Baseline through Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| CIN classification | Change from baseline of CIN classification | Baseline through Week 16 |
| Change of Reid's Colposcopic Index (RCI) | Change from baseline of RCI |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jae Hyung Lee | Contact | +82-31-280-9622 | jhlee@bioleaders.com |
| Name | Affiliation | Role |
|---|---|---|
| Jae-Kwan Lee, MD, PhD | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Recruiting | Ansan | Geyonggi-do | 15355 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
BLS-ILB-E710c-placebo |
|
| Baseline through Week 16 and Week 32 |
| Cytopathological classification | Change from baseline of cytopathological classification based on bethesda system | Baseline through Week 16 and Week 32 |
| Expression rate of P16/Ki-67 | 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 | 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 | Change from baseline as compared to placebo in HPV 16 clearance rate | Baseline through Week 16 |
| Change of RCI | Change of RCI based on the histopathological regression at Week 16 | Week 16 and Week 32 |
| CHA Bundang Medical Center, CHA University | Recruiting | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
|
| Catholic University of Korea, St. Vincent's Hospital | Recruiting | Suwon | Gyeonggi-do | 16247 | South Korea |
|
| Catholic University of Korea, Uijeongbu St. Mary's Hospital | Recruiting | Uijeongbu-si | Gyeonggi-do | 11765 | South Korea |
|
| The Dongsan Medical Center of Keimyung Hospital | Recruiting | Daegu | 700-712 | South Korea |
|
| Gachon University Gil Medical Center | Recruiting | Incheon | 21565 | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
|
| Yonsei Unversity Health System | Recruiting | Seoul | 03722 | South Korea |
|
| University of Ulsan College of Medicine, Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
|
| Catholic University of Korea, Seoul St. Mary's Hospital | Recruiting | Seoul | 06591 | South Korea |
|
| Hallym University Medical Center | Recruiting | Seoul | 07441 | South Korea |
|
| Kwandong University College of Medicine Cheil Hospital | Recruiting | Seoul | 100-380 | South Korea |
|
| CHA Gangnam Hospital | Recruiting | Seoul | 135-913 | South Korea |
|
| Korea University Guro Hospital | Recruiting | Seoul | 152-703 | South Korea |
|