A Phase 2 interventional study of Artesunate and Placebo in Anal High Grade Squamous Intraepithelial Lesion, Anal Precancerous Condition and AIN 2/3, sponsored by Frantz Viral Therapeutics, LLC. Active, not 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 suppositories 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 suppositories for the treatment of anal HSIL. Both groups receive four 5-day cycles of suppositories, at weeks 0, 2, 4, and 6. At least two of the dosing visits are done in person. The remaining dosing visits may be done as telehealth visits (suppositories are mailed to the patient's home). 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 suppositories in adult patients with biopsy-proven HPV-associated intra-anal HSIL (18 weeks).
Secondary Objectives:
Efficacy:
Safety:
To evaluate the safety of artesunate suppositories for the treatment of intra-anal HSIL.
Laboratory values at Screening of:
Exclusion Criteria:
Four 5-day cycles of artesunate suppositories
Drug: Artesunate
Four 5-day cycles of placebo suppositories
Drug: Placebo
artesunate formulated as intra-anal suppositories
Also known as: Artesunic acid, dihydroartemisinin (DHA), artemisinin
placebo intra-anal suppository
Number of subjects with complete and partial response by week 18
Number of participants who achieve complete or partial response after 4 5-day cycles of artesunate as determined by HRA-directed biopsy(ies)
Time frame: 18 weeks
Number of participants who have achieved clearance of detectable human papilloma virus (HPV) over the study window
Number of participants who had HPV strains detected at study entry which become undetectable within the study window
Time frame: 42 weeks
Number of participants with complete and partial response after week 18 but over the study window
Number of participants who achieve complete or partial response after week 18, as documented by HRA-directed biopsy(ies)
Time frame: 30 weeks
Number of participants who achieve complete and partial response of peri-anal HSIL, following 4 cycles of intra-anal artesunate suppositories, as determined by HRA-directed biopsy
Number of participants who had both peri-anal and intra-anal HSIL, whose peri-anal HSIL achieves complete or partial response following 4 cycles of intra-anal artesunate suppositories
Time frame: 42 weeks
Number of participants who undergo complete response who maintain their response over the study window
Number of participants who complete or partial response who maintain this response over the study window
Time frame: 42 weeks
Number of participants with Treatment-Emergent Adverse Events (TEAE)
Number of participants who had adverse events, as defined by CTCAE v5.0, related to the study intervention
Time frame: 12 weeks
Number of participants who withdrew from the study due to TEAEs
Number of participants who were withdrawn from the study due to adverse events related to the study drug
Time frame: 12 weeks
Changes in vital signs over the study window
Number of participants who had clinically significant changes in vital signs
Time frame: 42 weeks
Changes in physical examination abnormalities
Number of participants who had clinically significant changes in physical examination abnormalities
Time frame: 42 weeks
Clinically significant changes in ECG between baseline and post dosing
Number of participants who had clinical significant changes in ECG between pre-dosing and post dosing
Time frame: 8 weeks
Plan to share: No — No protected health information (PHI) will be shared with other researchers.
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This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Frantz Viral Therapeutics, LLC