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Status unknownNCT03274206Updated Feb 7, 2020

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

A Phase 2 interventional study of BLS-ILB-E710c and Placebo in Cervical Intraepithelial Neoplasia Grade 2/3, sponsored by BioLeaders Corporation. Status unknown at 14 sites in South Korea. Open to female participants aged 20 Years to 49 Years. Per ClinicalTrials.gov, last updated 2020-02-07.

Sponsored by BioLeaders Corporation · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
20 Years to 49 Years
Sex
Female
01

Study 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.

Read the 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]
02

Conditions studied

  • Cervical Intraepithelial Neoplasia Grade 2/3

Keywords

  • Cervical Intraepithelian Neoplasia Grade 2/3
  • CIN 2/3
  • HPV
03

In context

Lead sponsor

BioLeaders Corporation is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
126 participants (estimated)

Study arms

  • 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)

    Biological: BLS-ILB-E710c

  • 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)

    Drug: Placebo

Interventions

  • BiologicalBLS-ILB-E710c

    BLS-ILB-E710c 250mg/capsule

  • DrugPlacebo

    BLS-ILB-E710c-placebo

06

What researchers measure

Primary outcomes

  1. Regression rate

    The rate of complete histopathological regression from baseline as compared to placebo

    Time frame: Baseline through Week 16

Secondary outcomes

  1. CIN classification

    Change from baseline of CIN classification

    Time frame: Baseline through Week 16

  2. Change of Reid's Colposcopic Index (RCI)

    Change from baseline of RCI

    Time frame: Baseline through Week 16 and Week 32

  3. Cytopathological classification

    Change from baseline of cytopathological classification based on bethesda system

    Time frame: Baseline through Week 16 and Week 32

  4. 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

  5. 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

  6. HPV 16 clearance rate

    Change from baseline as compared to placebo in HPV 16 clearance rate

    Time frame: Baseline through Week 16

  7. Change of RCI

    Change of RCI based on the histopathological regression at Week 16

    Time frame: Week 16 and Week 32

07

Study locations

14 of 14 sites recruiting
  • Korea University Ansan Hospital
    Ansan, Geyonggi-do 15355, South Korea
    Recruiting
  • CHA Bundang Medical Center, CHA University
    Seongnam-si, Gyeonggi-do 13496, South Korea
    Recruiting
  • Catholic University of Korea, St. Vincent's Hospital
    Suwon, Gyeonggi-do 16247, South Korea
    Recruiting
  • Catholic University of Korea, Uijeongbu St. Mary's Hospital
    Uijeongbu-si, Gyeonggi-do 11765, South Korea
    Recruiting
  • The Dongsan Medical Center of Keimyung Hospital
    Daegu, 700-712, South Korea
    Recruiting
  • Gachon University Gil Medical Center
    Incheon, 21565, South Korea
    Recruiting
  • Seoul National University Hospital
    Seoul, 03080, South Korea
    Recruiting
    • Jae-Weon Kim, MD, PhD · Contact+82-2-2072-3511
    • Yeon-Jae Han · Contact
  • Yonsei Unversity Health System
    Seoul, 03722, South Korea
    Recruiting
  • University of Ulsan College of Medicine, Asan Medical Center
    Seoul, 05505, South Korea
    Recruiting
    • Yong-Man Kim, MD, Ph.D · Contact+82-2-3010-3640
    • Geum-hee Nah · Contact+82-2-3010-3627
  • Catholic University of Korea, Seoul St. Mary's Hospital
    Seoul, 06591, South Korea
    Recruiting
  • Hallym University Medical Center
    Seoul, 07441, South Korea
    Recruiting
  • Kwandong University College of Medicine Cheil Hospital
    Seoul, 100-380, South Korea
    Recruiting
  • CHA Gangnam Hospital
    Seoul, 135-913, South Korea
    Recruiting
    • Seok Ju Seong, MD, PhD · Contact
  • Korea University Guro Hospital
    Seoul, 152-703, South Korea
    Recruiting
    • Jae-Kwan Lee, MD, PhD · Contactjklee38@korea.ac.kr · +82-2626-3142
    • Jae-Kwan Lee, MD, PhD · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2017 (actual). Primary completion is estimated for Aug 2020, 36 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 5, 2017
First posted
Sep 6, 2017
StartActual
Aug 30, 2017
Primary completionEst.
Aug 2020
CompletionEst.
Aug 2020
Last update
Feb 7, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03274206
Lead sponsor
BioLeaders Corporation
Responsible party
Sponsor
First posted
Sep 6, 2017
Start date
Aug 30, 2017
Primary completion
Aug 2020 (estimated)
Completion
Aug 2020 (estimated)
Last update
Feb 7, 2020

Study contacts

Jae Hyung Lee
Contact
jhlee@bioleaders.com
+82-31-280-9622
Jae-Kwan Lee, MD, PhD
principal investigator · Korea University Guro Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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