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)
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Regression rate
Secondary Outcome
CIN classification
Condition
Cervical Intraepithelial Neoplasia Grade 2/3
Intervention
BLS-ILB-E710c
Study Arms / Comparison Groups
BLS-ILB-E710c
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)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
126
Start Date
August 30, 2017
Completion Date
August 2020
Primary Completion Date
August 2020
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)
Gender
Female
Ages
20 Years - 49 Years
Accepts Healthy Volunteers
No
Contacts
Jae-Kwan Lee, MD, PhD, +82-31-280-9622, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT03274206
Organization ID
BLS-ILB-E710c-202
Secondary IDs
12591
Responsible Party
Sponsor
Study Sponsor
BioLeaders Corporation
Study Sponsor
Jae-Kwan Lee, MD, PhD, Principal Investigator, Korea University Guro Hospital
Verification Date
February 2020