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

Cervical Intraepithelial Neoplasia Grade 2/3 Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03274206
• Other study ID #: BLS-ILB-E710c-202
• Secondary ID: 12591
• Status: Recruiting
• Phase: Phase 2
• Start date: August 30, 2017
• Est. completion date: August 2020

Study information

• Verified date: February 2020
• Source: BioLeaders Corporation
• Contact: Jae Hyung Lee
• Phone: +82-31-280-9622
• Email: jhlee[@]bioleaders.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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]

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 49 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Cervical Intraepithelial Neoplasia Grade 2/3
• Neoplasms

Intervention

Biological:
• BLS-ILB-E710c
BLS-ILB-E710c 250mg/capsule

Drug:
• Placebo
BLS-ILB-E710c-placebo

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan	Geyonggi-do
Korea, Republic of	The Dongsan Medical Center of Keimyung Hospital	Daegu
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam si	Gyeonggi-do
Korea, Republic of	Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	CHA Gangnam Hospital	Seoul
Korea, Republic of	Hallym University Medical Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kwandong University College of Medicine Cheil Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	University of Ulsan College of Medicine, Asan Medical Center	Seoul
Korea, Republic of	Yonsei Unversity Health System	Seoul
Korea, Republic of	Catholic University of Korea, St. Vincent's Hospital	Suwon	Gyeonggi-do
Korea, Republic of	Catholic University of Korea, Uijeongbu St. Mary's Hospital	Uijeongbu	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
BioLeaders Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regression rate	The rate of complete histopathological regression from baseline as compared to placebo	Baseline through Week 16
Secondary	CIN classification	Change from baseline of CIN classification	Baseline through Week 16
Secondary	Change of Reid's Colposcopic Index (RCI)	Change from baseline of RCI	Baseline through Week 16 and Week 32
Secondary	Cytopathological classification	Change from baseline of cytopathological classification based on bethesda system	Baseline through Week 16 and Week 32
Secondary	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
Secondary	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
Secondary	HPV 16 clearance rate	Change from baseline as compared to placebo in HPV 16 clearance rate	Baseline through Week 16
Secondary	Change of RCI	Change of RCI based on the histopathological regression at Week 16	Week 16 and Week 32