Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
GX-188E with GX-I7 or Imiquimod in CIN3
NCT03206138Phase 2
Key facts
- Status
- Unknown
- Start
- May 2017
- Primary completion
- Oct 2018
- Countries
- 1
- Sponsor
- Seoul St. Mary's Hospital
- Modality
- Prophylactic Vaccines, Cytokines & Interferons, DNA Vaccines
- Conditions
- cervical intraepithelial neoplasia (CIN)
01
Overview
Phase 2, randomised, open-label trial in cervical intraepithelial neoplasia (CIN) comparing GX-188E + GX-I7 with GX-188E + Imiquimod (2 arms). Primary endpoint: Ratio of subjects who have histopathological regression of cervical lesions to CIN 1 or less at 20 weeks. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
GX-188E + GX-I7
GX-188E IM (3 times) + GX-I7 intravaginal (4 times)
GX-188E + Imiquimod
GX-188E IM (3 times) + Imiquimod topical (8 times)
03
Who it enrols
Female patients aged 19-50 with histopathologically diagnosed CIN 3 and HPV 16/18 positivity. Excludes pregnant/breastfeeding women and those with HIV, HBV, or HCV.
04
Endpoints
Primary
Ratio of subjects who have histopathological regression of cervical lesions to CIN 1 or less
Secondary
Ratio of subjects with clearance of HPV 16 or 18 and histopathological regression of cervical lesions to CIN 1 or less
The change of cytology of uterine cervix compared to baseline
Flt-3L concentrations in blood samples
Beyond the preview
Go deeper on NCT03206138.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT03206138.