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NCT03721978 · ClinicalTrials.gov registry record · Phase 3

REVEAL 2 Trial (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
203
Enrollment target
20
Study locations

NCT03721978 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 203 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 14 states.

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The verdict

NCT03721978, 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
203 participants
Enrollment target
20
Study locations

Study Summary

HPV-303 is a prospective, randomized, double-blind, placebo-controlled study of VGX-3100 delivered intramuscularly (IM) followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed high-grade squamous intraepithelial lesions (HSIL) (cervical intraepithelial neoplasia grade 2 \[CIN2\] or grade 3 \[CIN3\]) of the cervix, associated with human papillomavirus (HPV-16) and/or HPV-18.

Conditions Studied

Cervical Dysplasia Cervical High Grade Squamous Intraepithelial Lesion HSIL

Interventions

  • BIOLOGICAL VGX-3100
  • BIOLOGICAL Matched Placebo
  • DEVICE CELLECTRA™-5PSP

Study Locations (20)

Florida

  • Altus Research - Lake Worth
  • Salom and Tangir LLC - Miramar
  • Precision Clinical Research, LLC - Sunrise

New York

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

North Carolina

  • Unified Women's Clinical Research - Greensboro - Greensboro
  • Unified Women's Clinical Research - Morehead City - Morehead City
  • Lyndhurst Clinical Research - Winston-Salem

Arizona

  • Visions Clinical Research- Tucson - Tucson

Connecticut

  • Nuvance Health - Danbury

Delaware

  • Christiana Care Health System - Newark

Georgia

  • Augusta University - Augusta

Illinois

  • Affinity Clinical Research Institute - Oak Brook

Trial Details

FieldValue
Enrollment Target 203 participants
Start Date 2019-02-28
Est. Completion 2022-09-15
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 NCT03721978

The ClinicalTrials.gov registry entry for NCT03721978 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 203 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 VGX-3100 is the first listed.

NCT03721978 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Florida, New York, North Carolina.

Frequently Asked Questions

What is clinical trial NCT03721978 about?

NCT03721978 is a clinical study titled "REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)". HPV-303 is a prospective, randomized, double-blind, placebo-controlled study of VGX-3100 delivered intramuscularly (IM) followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed high-grade squamous intraepithelial lesions (HSIL) (cervical intraepith...

What is the current status of trial NCT03721978?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 203 participants. The study started on 2019-02-28. Estimated completion is 2022-09-15.

What conditions does trial NCT03721978 study?

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

What interventions are being tested in trial NCT03721978?

The interventions under investigation include: VGX-3100 (BIOLOGICAL), Matched Placebo (BIOLOGICAL), CELLECTRA™-5PSP (DEVICE).

Who is sponsoring clinical trial NCT03721978?

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

Where is trial NCT03721978 being conducted?

This trial has 20 study locations across Arizona, Connecticut, Delaware, Florida, Georgia. 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.