A Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
A Phase 2b Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
2 other identifiers
interventional
126
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2017
Typical duration for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 30, 2017
CompletedFirst Submitted
Initial submission to the registry
September 5, 2017
CompletedFirst Posted
Study publicly available on registry
September 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedFebruary 7, 2020
February 1, 2020
2.9 years
September 5, 2017
February 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Regression rate
The rate of complete histopathological regression from baseline as compared to placebo
Baseline through Week 16
Secondary Outcomes (7)
CIN classification
Baseline through Week 16
Change of Reid's Colposcopic Index (RCI)
Baseline through Week 16 and Week 32
Cytopathological classification
Baseline through Week 16 and Week 32
Expression rate of P16/Ki-67
Baseline through Week 16
The number of CD8 positive cells in the cervix
Baseline through Week 16
- +2 more secondary outcomes
Study Arms (2)
BLS-ILB-E710c
EXPERIMENTAL* 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 COMPARATOR* Drug: BLS-ILB-E710c-placebo * Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Korea University Ansan Hospital
Ansan, Geyonggi-do, 15355, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, 13496, South Korea
Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247, South Korea
Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, Gyeonggi-do, 11765, South Korea
The Dongsan Medical Center of Keimyung Hospital
Daegu, 700-712, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Yonsei Unversity Health System
Seoul, 03722, South Korea
University of Ulsan College of Medicine, Asan Medical Center
Seoul, 05505, South Korea
Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Hallym University Medical Center
Seoul, 07441, South Korea
Kwandong University College of Medicine Cheil Hospital
Seoul, 100-380, South Korea
CHA Gangnam Hospital
Seoul, 135-913, South Korea
Korea University Guro Hospital
Seoul, 152-703, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Jae-Kwan Lee, MD, PhD
Korea University Guro Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2017
First Posted
September 6, 2017
Study Start
August 30, 2017
Primary Completion
August 1, 2020
Study Completion
August 1, 2020
Last Updated
February 7, 2020
Record last verified: 2020-02