A Phase 2 interventional study of Artesunate ointment and Placebo in Anal High-grade Squamous Intraepithelial Lesion, Anal HSIL and Anal HPV Infection, sponsored by Frantz Viral Therapeutics, LLC. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by Frantz Viral Therapeutics, LLC · Phase 2, Interventional, and Treatment
This is a phase II double blind, placebo-controlled, randomized study of artesunate ointment for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL)
Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo ointment for the treatment of anal HSIL. Both groups receive four 5-day cycles of ointment, at weeks 0, 2, 4, and 6. Participants are followed closely with anoscopy or high resolution anoscopy (HRA) at weeks 8, 18, 30, and 42. After the week 18 HRA visit, participants who have at least partial response will be followed with HRA at week 30.
Participants who are found to be non-responders at week 18 will undergo standard of care ablation.
Participants who are found to have anal HSIL at weeks 30 or 42 will be followed according to standard of care procedures.
Primary Objective: To evaluate the complete and partial histopathologic response to four 5-day cycles of artesunate ointment in adult patients with biopsy-proven HPV-associated intra-anal HSIL (18 weeks).
Secondary Objectives:
Efficacy:
To evaluate the viral clearance after four 5-day cycles of artesunate ointment To evaluate complete and partial intra-anal response To evaluate complete and partial peri-anal response To evaluate persistence of response throughout the study window
Safety:
To evaluate the safety of artesunate ointment for the treatment of intra-anal HSIL.
Laboratory values at Screening of:
Exclusion Criteria:
Drug: Artesunate ointment
Drug: Placebo
Four 5-day cycles of artesunate ointment given at weeks 0, 2, 4, 6
Also known as: Artesunic acid, Dihydroartemisinin (DHA), Artemisinin
Four 5-day cycles of placebo ointment given at weeks 0, 2, 4, 6
Also known as: placebo ointment
Complete and partial response by week 18
Number of participants with complete and partial response after four 5-day cycles of artesunate ointment
Time frame: 18 weeks
HPV clearance
Number of participants who do not have detectable HPV infection
Time frame: 42 weeks
Complete and partial response after week 18
Number of participants with complete and partial response after week 18
Time frame: 30 weeks
Complete and partial peri-anal response after intra-anal ointment application
Number of participants who have complete and partial peri-anal response after 4 5-day cycles of intra-anal ointment
Time frame: 42 weeks
Persistence of response
Number of participants who have complete response and do not have recurrence of anal HSIL
Time frame: 42 weeks
Safety of intra-anal artesunate ointment
Number of participants who do not have any drug-related serious adverse events
Time frame: 42 weeks
Plan to share: No — No protected health information (PHI) will be shared with other researchers.
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Frantz Viral Therapeutics, LLC