Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)

HPV Infection Clinical Trial

— ART-VIN IIB  

Official title:

A Phase II Double-blind, Placebo-controlled, Randomized Trial of Topical Artesunate Ointment for the Treatment of Patients With Vulvar High-grade Squamous Intraepithelial Lesions (Vulvar HSIL)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06075264
• Other study ID #: ART-VIN IIB
• Secondary ID: 23-889
• Status: Recruiting
• Phase: Phase 2
• Start date: December 6, 2023
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Frantz Viral Therapeutics, LLC
• Contact: Mihaela Plesa
• Phone: 440-255-1155
• Email: fvtinfo[@]frantzgroup.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase II double-blind, placebo-controlled study of artesunate ointment for the treatment of HPV-associated vulvar HSIL (usual type vulvar intraepithelial neoplasia 2/3).

Description:

Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo ointment for the treatment of vulvar HSIL. Both groups receive four 5-day cycles of topical ointment, at weeks 0, 2, 4, and 6. Dosing visits may be done in person or as telehealth (ointment may be shipped directly to the patient). Participants are followed closely with vulvar examinations or colposcopies at weeks 8, 18, 6-months and 12-months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult women age = 18 years

• Capable of informed consent

• Able to collaborate with planned follow-up (transportation, compliance history, etc)

• Biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2/3, HSIL), including both new and recurrent disease. A biopsy diagnosis of vulvar high-grade squamous intraepithelial lesion within the previous 3 months which was not excised or otherwise treated may be accepted for study entry.

• Positive HPV test at study entry (any genotype).

• Women of childbearing potential agree to use birth control during the dosing phase (through week 8).

• Laboratory values at Screening of:

• Serum alanine transaminase (SGPT/ALT) < 5 x upper limit of normal (ULN)

• Serum aspartate transaminase (SGOT/AST) < 5 x ULN

• Serum Bilirubin (total) < 2.5 x ULN

• Serum Creatinine = 1.5 x ULN

• Weight = 50kg

Exclusion Criteria:

• Pregnant and nursing women

• Concurrent anal, vulvar, or cervical cancer

• HIV-positive participants with a CD4 count < 200

• Participants infected with HIV-1 if not on a stable, suppressive antiretroviral therapy (ART) regimen.

• Unwillingness to undergo an excisional procedure at week 18 to either remove HSIL lesions, or to document histologic regression at a site where HSIL was present at study entry.

• Currently receiving systemic chemotherapy or radiation therapy for another cancer.

• Concomitant use of Efavirenz for HIV antiretroviral treatment

• Concomitant use of strong UGT inhibitors

• Concomitant use of imiquimod, cidofovir, or 5-fluorouracil (5-FU) for the duration of the study

• Concurrent dermatological conditions affecting the vulva (e.g., herpetic lesion, Crohn's disease, hidradenitis suppurativa) or vulvar dermatoses (e.g., lichen sclerosis or planus, atopic dermatitis, genital atrophy).

• Concurrent treatment with systemic corticosteroids

Related Conditions & MeSH terms

• High Grade Intraepithelial Neoplasia
• HPV Disease
• HPV Infection
• Papillomavirus Infections
• Pre-Cancerous Dysplasia
• Vin III
• Vulvar Diseases
• Vulvar HSIL

Intervention

Drug:
• Artesunate ointment
topical ointment, as a non-surgical treatment
• Placebo ointment
topical placebo ointment

Locations

Country	Name	City	State
United States	Cleveland Clinic Fairview Hospital	Cleveland	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Florida Gynecologic Oncology	Fort Myers	Florida
United States	Hillcrest Hospital	Mayfield Heights	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Frantz Viral Therapeutics, LLC	The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with complete histologic response	Number of participants who have complete histologic response following topical artesunate ointment	18 weeks
Secondary	Number of participants who have achieved viral clearance	Number of participants who achieve clearance of HPV genotypes present at screening. These genotypes become undetectable over the study window.	Week 18
Secondary	Number of participants who show partial response	Number of participants with documented partial response following topical artesunate	Week 18
Secondary	Number of participants who have durable response	Number of participants with documented complete response who do not have recurrence of their vulvar HSIL over the study window	Week 18
Secondary	Incidence of Treatment-Emergent Adverse Events (TEAE)	Number of participants who report artesunate-related serious adverse events	8 weeks