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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2020

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

  • Biological: BLS-ILB-E710c
    • BLS-ILB-E710c 250mg/capsule
  • Drug: Placebo
    • BLS-ILB-E710c-placebo

Arms, Groups and Cohorts

  • Experimental: BLS-ILB-E710c
    • Drug: BLS-ILB-E710c 1,000mg Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8)
  • Placebo Comparator: BLS-ILB-E710c-placebo
    • Drug: BLS-ILB-E710c-placebo Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8)

Clinical Trial Outcome Measures

Primary Measures

  • Regression rate
    • Time Frame: Baseline through Week 16
    • The rate of complete histopathological regression from baseline as compared to placebo

Secondary Measures

  • CIN classification
    • Time Frame: Baseline through Week 16
    • Change from baseline of CIN classification
  • Change of Reid’s Colposcopic Index (RCI)
    • Time Frame: Baseline through Week 16 and Week 32
    • Change from baseline of RCI
  • Cytopathological classification
    • Time Frame: Baseline through Week 16 and Week 32
    • Change from baseline of cytopathological classification based on bethesda system
  • Expression rate of P16/Ki-67
    • Time Frame: Baseline through Week 16
    • Change from baseline as compared to placebo of the expression rate of P16/Ki-67
  • The number of CD8 positive cells in the cervix
    • Time Frame: Baseline through Week 16
    • Change from baseline as compared to placebo in the number of CD8 positive cells in the cervix
  • HPV 16 clearance rate
    • Time Frame: Baseline through Week 16
    • Change from baseline as compared to placebo in HPV 16 clearance rate
  • Change of RCI
    • Time Frame: Week 16 and Week 32
    • Change of RCI based on the histopathological regression at Week 16

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 49 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • BioLeaders Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jae-Kwan Lee, MD, PhD, Principal Investigator, Korea University Guro Hospital
  • Overall Contact(s)
    • Jae Hyung Lee, +82-31-280-9622, jhlee@bioleaders.com

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