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

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.

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)

Keywords: cervical intraepithelian neoplasia grade 2/3 cin 2/3 hpv