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

BioLeaders

Status and phase: Unknown; Phase 2

Conditions: Cervical Intraepithelial Neoplasia Grade 2/3

Treatments: Drug: Placebo; Biological: BLS-ILB-E710c

Study type: Interventional

Funder types: Industry

Identifiers

NCT03274206

12591 (Other Identifier)

BLS-ILB-E710c-202

Details and patient eligibility

About

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 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]

Enrollment: 126 estimated patients

Sex: Female

Ages: 20 to 49 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 2 patient groups, including a placebo group

BLS-ILB-E710c

Experimental group

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)

Treatment:

Biological: BLS-ILB-E710c

BLS-ILB-E710c-placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo