Clinical Trials Directory

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UnknownNCT03274206

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

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

Status
Unknown
Phase
Phase 2
Study type
Interventional
Enrollment
126 (estimated)
Sponsor
BioLeaders Corporation · Industry
Sex
Female
Age
20 Years – 49 Years
Healthy volunteers
Not accepted

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 \[Time Frame: Week 16 through Week 32\]

Conditions

Interventions

TypeNameDescription
BIOLOGICALBLS-ILB-E710cBLS-ILB-E710c 250mg/capsule
DRUGPlaceboBLS-ILB-E710c-placebo

Timeline

Start date
2017-08-30
Primary completion
2020-08-01
Completion
2020-08-01
First posted
2017-09-06
Last updated
2020-02-07

Locations

14 sites across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03274206. Inclusion in this directory is not an endorsement.