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NCT03185013 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Cervical Dysplasia and Cervical High Grade Squamous Intraepithelial Lesion, sponsored by Inovio Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
201
Enrollment target
20
Study locations

NCT03185013 is a Phase 3 study of Cervical Dysplasia and Cervical High Grade Squamous Intraepithelial Lesion that has completed, run by Inovio Pharmaceuticals. The registered enrollment target is 201 participants, below the 520-participant average among 7 other Cervical Dysplasia trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT03185013, a Phase 3 study of Cervical Dysplasia and Cervical High Grade Squamous Intraepithelial Lesion, has completed, sponsored by Inovio Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
201 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Cervical Dysplasia Cervical High Grade Squamous Intraepithelial Lesion HSIL

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL VGX-3100
  • DEVICE Electroporation (EP)

Study Locations (20)

Florida

  • Women's Medical Research Group - Clearwater
  • Altus Research - Lake Worth
  • Salom and Tangir LLC - Miramar
  • Comprehensive Clinical Trials LLC - West Palm Beach

Arizona

  • Mesa Obstetricians and Gynecologist - Mesa
  • Women's Health Research - Scottsdale
  • Visions Clinical Research-Tucson - Tucson

New York

  • Columbia University Medical Center - New York
  • Suffolk Obstetrics and Gynecology - Port Jefferson

South Carolina

  • Greenville Pharmaceutical Research, Inc. - Greenville
  • Magnolia Ob/Gyn Research Center, LLC - Myrtle Beach

Tennessee

  • Chattanooga Medical Research Inc - Chattanooga
  • Women's Physician Group - Memphis

Georgia

  • Augusta University - Augusta

Louisiana

  • Praetorian Pharmaceutical Research, LLC - Marrero

Michigan

  • Saginaw Valley Medical Research Group LLC - Saginaw

Trial Details

FieldValue
Enrollment Target 201 participants
Start Date 2017-06-28
Est. Completion 2021-04-06
Phase Phase 3

Sponsor

Inovio Pharmaceuticals

28 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03185013

The ClinicalTrials.gov registry entry for NCT03185013 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 201 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 520-participant average among 7 other Cervical Dysplasia trials with a reported enrollment target (61% lower). The listed sponsor is Inovio Pharmaceuticals, which has 28 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Cervical Dysplasia appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT03185013 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, Arizona, New York.

Frequently Asked Questions

What is clinical trial NCT03185013 about?

NCT03185013 is a clinical study titled "REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)". 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 confirm...

What is the current status of trial NCT03185013?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 201 participants. The study started on 2017-06-28. Estimated completion is 2021-04-06.

What conditions does trial NCT03185013 study?

This clinical trial studies the following conditions: Cervical Dysplasia, Cervical High Grade Squamous Intraepithelial Lesion, HSIL.

What interventions are being tested in trial NCT03185013?

The interventions under investigation include: Placebo (BIOLOGICAL), VGX-3100 (BIOLOGICAL), Electroporation (EP) (DEVICE).

Who is sponsoring clinical trial NCT03185013?

This trial is sponsored by Inovio Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03185013 being conducted?

This trial has 20 study locations across Arizona, Florida, Georgia, Louisiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.