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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: Completed Phase 3 study of Cervical Dysplasia and Cervical High Grade Squamous Intraepithelial Lesion, sponsored by Inovio Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL, no evidence of HPV-16 and/or HPV-18 at the Week 36 time frame, and participants in which excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined by histology as negative, squamous atypia, or low-grade intraepithelial lesion (LSIL). Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep®
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2017-06-28 |
| Est. Completion | 2021-04-06 |
| Phase | Phase 3 |
What the finished NCT03185013 record still lists
NCT03185013 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, below the 520-participant average among 7 other Cervical Dysplasia trials with a reported enrollment target (61% lower).
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 names 20 study sites across 12 states, led by 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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