A Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)

Study Overview
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Brief Summary
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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
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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]

Official Title
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A Phase 2b Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)

Conditions
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Cervical Intraepithelial Neoplasia Grade 2/3

Intervention / Treatment
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* Biological: BLS-ILB-E710c
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLS-ILB-E710c<br>Drug: BLS-ILB-E710c 1,000mg Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8) | Biological: BLS-ILB-E710c<br>* BLS-ILB-E710c 250mg/capsule<br>|
| Placebo Comparator: BLS-ILB-E710c-placebo<br>Drug: BLS-ILB-E710c-placebo Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8) | Drug: Placebo<br>* BLS-ILB-E710c-placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regression rate | The rate of complete histopathological regression from baseline as compared to placebo | Baseline through Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CIN classification | Change from baseline of CIN classification | Baseline through Week 16 | 
| Change of Reid's Colposcopic Index (RCI) | Change from baseline of RCI | Baseline through Week 16 and Week 32 | 
| Cytopathological classification | Change from baseline of cytopathological classification based on bethesda system | 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 | 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 | Baseline through Week 16 | 
| HPV 16 clearance rate | Change from baseline as compared to placebo in HPV 16 clearance rate | Baseline through Week 16 | 
| Change of RCI | Change of RCI based on the histopathological regression at Week 16 | Week 16 and Week 32 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Intraepithelian Neoplasia Grade 2/3, CIN 2/3, HPV