A Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
- Conditions
- Cervical Intraepithelial Neoplasia Grade 2/3
- Interventions
- Biological: BLS-ILB-E710cDrug: Placebo
- Registration Number
- NCT03274206
- Lead Sponsor
- 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.
- 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 \[Time Frame: Week 16 through Week 32\]
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 126
-
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
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BLS-ILB-E710c 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) BLS-ILB-E710c-placebo Placebo * Drug: BLS-ILB-E710c-placebo * Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8)
- Primary Outcome Measures
Name Time Method Regression rate Baseline through Week 16 The rate of complete histopathological regression from baseline as compared to placebo
- Secondary Outcome Measures
Name Time Method Change of Reid's Colposcopic Index (RCI) Baseline through Week 16 and Week 32 Change from baseline of RCI
Cytopathological classification Baseline through Week 16 and Week 32 Change from baseline of cytopathological classification based on bethesda system
Expression rate of P16/Ki-67 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 Baseline through Week 16 Change from baseline as compared to placebo in the number of CD8 positive cells in the cervix
CIN classification Baseline through Week 16 Change from baseline of CIN classification
HPV 16 clearance rate Baseline through Week 16 Change from baseline as compared to placebo in HPV 16 clearance rate
Change of RCI Week 16 and Week 32 Change of RCI based on the histopathological regression at Week 16
Trial Locations
- Locations (14)
The Dongsan Medical Center of Keimyung Hospital
🇰🇷Daegu, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Catholic University of Korea, Uijeongbu St. Mary's Hospital
🇰🇷Uijeongbu, Gyeonggi-do, Korea, Republic of
University of Ulsan College of Medicine, Asan Medical Center
🇰🇷Seoul, Korea, Republic of
CHA Gangnam Hospital
🇰🇷Seoul, Korea, Republic of
Catholic University of Korea, St. Vincent's Hospital
🇰🇷Suwon, Gyeonggi-do, Korea, Republic of
Yonsei Unversity Health System
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
CHA Bundang Medical Center, CHA University
🇰🇷Seongnam si, Gyeonggi-do, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan, Geyonggi-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Hallym University Medical Center
🇰🇷Seoul, Korea, Republic of
Kwandong University College of Medicine Cheil Hospital
🇰🇷Seoul, Korea, Republic of