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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: Completed Phase 3 study of Cervical Dysplasia and Cervical High Grade Squamous Intraepithelial Lesion, sponsored by Inovio Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Baseline biomarker-positive participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL, no evidence of HPV-16 and/or HPV-18 at Week 36, and participants who did not have unscheduled excision or biopsy sample 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 coll
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2019-02-28 |
| Est. Completion | 2022-09-15 |
| Phase | Phase 3 |
What the finished NCT03721978 record still lists
NCT03721978 is an interventional study that assigns participants to a tested intervention. The registered 203 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 VGX-3100 is the first listed.
NCT03721978 names 20 study sites across 14 states, led by 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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