Clinical trial NCT03274206: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cervical Intraepithelial Neoplasia Grade 2/3
Keywords: Cervical Intraepithelian Neoplasia Grade 2/3
CIN 2/3
HPV
Lead sponsor: BioLeaders Corporation
Sponsor class: INDUSTRY
First posted: 2017-09-06
Enrollment: 126
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[Time Frame: Week 16 through Week 32\]

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)

Primary outcomes:
measure: Regression rate
timeFrame: Baseline through Week 16
Secondary outcomes:
measure: CIN classification
timeFrame: Baseline through Week 16
measure: Change of Reid's Colposcopic Index (RCI)
timeFrame: Baseline through Week 16 and Week 32
measure: Cytopathological classification
timeFrame: Baseline through Week 16 and Week 32
measure: Expression rate of P16/Ki-67
timeFrame: Baseline through Week 16
measure: The number of CD8 positive cells in the cervix
timeFrame: Baseline through Week 16
measure: HPV 16 clearance rate
timeFrame: Baseline through Week 16
measure: Change of RCI
timeFrame: Week 16 and Week 32
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Geyonggi-do
city: Seongnam si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggi-do
city: Uijeongbu
country: Korea, Republic of
facility: Catholic University of Korea, Uijeongbu St. Mary's Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: The Dongsan Medical Center of Keimyung Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei Unversity Health System
city: Seoul
country: Korea, Republic of
facility: University of Ulsan College of Medicine, Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Medical Center
city: Seoul
country: Korea, Republic of
facility: Kwandong University College of Medicine Cheil Hospital
city: Seoul
country: Korea, Republic of
facility: CHA Gangnam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Jae-Kwan Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: