Cervical Intraepithelial Neoplasia Grade 2/3
Conditions
Keywords
Cervical Intraepithelian Neoplasia Grade 2/3, CIN 2/3, HPV
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 \[Time Frame: Week 16 through Week 32\]
Interventions
BIOLOGICALBLS-ILB-E710c
BLS-ILB-E710c 250mg/capsule
DRUGPlacebo
BLS-ILB-E710c-placebo
Sponsors
BioLeaders Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 49 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regression rate | Baseline through Week 16 | The rate of complete histopathological regression from baseline as compared to placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Reid's Colposcopic Index (RCI) | Baseline through Week 16 and Week 32 | Change from baseline of RCI |
| Cytopathological classification | Baseline through Week 16 and Week 32 | Change from baseline of cytopathological classification based on bethesda system |
| Expression rate of P16/Ki-67 | Baseline through Week 16 | Change from baseline as compared to placebo of the expression rate of P16/Ki-67 |
| CIN classification | Baseline through Week 16 | Change from baseline of CIN classification |
| HPV 16 clearance rate | Baseline through Week 16 | Change from baseline as compared to placebo in HPV 16 clearance rate |
| Change of RCI | Week 16 and Week 32 | Change of RCI based on the histopathological regression at Week 16 |
| The number of CD8 positive cells in the cervix | Baseline through Week 16 | Change from baseline as compared to placebo in the number of CD8 positive cells in the cervix |
Countries
South Korea
Contacts
Primary ContactJae Hyung Lee
Outcome results
None listed