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

Brief Title

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

Official Title

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

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]
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Regression rate

Secondary Outcome

 CIN classification

Condition

Cervical Intraepithelial Neoplasia Grade 2/3

Intervention

BLS-ILB-E710c

Study Arms / Comparison Groups

 BLS-ILB-E710c

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

126

Start Date

August 30, 2017

Completion Date

August 2020

Primary Completion Date

August 2020

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)
      

Gender

Female

Ages

20 Years - 49 Years

Accepts Healthy Volunteers

No

Contacts

Jae-Kwan Lee, MD, PhD, +82-31-280-9622, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

NCT ID

NCT03274206

Organization ID

BLS-ILB-E710c-202

Secondary IDs

12591

Responsible Party

Sponsor

Study Sponsor

BioLeaders Corporation

Study Sponsor

Jae-Kwan Lee, MD, PhD, Principal Investigator, Korea University Guro Hospital

Verification Date

February 2020