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: * 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
126
BLS-ILB-E710c 250mg/capsule
BLS-ILB-E710c-placebo
Korea University Ansan Hospital
Ansan, Geyonggi-do, South Korea
RECRUITINGCHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea
Regression rate
The rate of complete histopathological regression from baseline as compared to placebo
Time frame: Baseline through Week 16
CIN classification
Change from baseline of CIN classification
Time frame: Baseline through Week 16
Change of Reid's Colposcopic Index (RCI)
Change from baseline of RCI
Time frame: Baseline through Week 16 and Week 32
Cytopathological classification
Change from baseline of cytopathological classification based on bethesda system
Time frame: 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
Time frame: 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
Time frame: Baseline through Week 16
HPV 16 clearance rate
Change from baseline as compared to placebo in HPV 16 clearance rate
Time frame: Baseline through Week 16
Change of RCI
Change of RCI based on the histopathological regression at Week 16
Time frame: Week 16 and Week 32
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RECRUITING...and 4 more locations