Last updated on April 2018

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


Brief description of study

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 Study 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]

Clinical Study Identifier: NCT03274206

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