drugset / Trial / NCT03185013

REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)

NCT03185013

Phase 3 Completed 201 enrolled Inovio Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

HPV-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 \[CIN2\] or grade 3 \[CIN3\]) associated with human papillomavirus (HPV) 16 and/or HPV-18.

Timeline

Start
2017-06-28
Primary completion
2020-07-08
Completion
2021-04-06

Drugs

EvaluationDrugModalityDoseRoute
Subject BIZALIMOGENE RALAPLASMID Vaccine 6 mg Intramuscular