Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants

NCT06206564 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ART-AIN IIB-2
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

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)

Conditions

Anal High-grade Squamous Intraepithelial Lesion; Anal HSIL; Anal HPV Infection; AIN

Keywords

intra-anal; topical; non-surgical

Outcome Measures

Primary Outcomes (1)

• Complete and partial response by week 18

  Number of participants with complete and partial response after four 5-day cycles of artesunate ointment

  18 weeks

Secondary Outcomes (4)

• HPV clearance

  42 weeks

• Complete and partial response after week 18

  30 weeks

• Complete and partial peri-anal response after intra-anal ointment application

  42 weeks

• Persistence of response

  42 weeks

Other Outcomes (1)

• Safety of intra-anal artesunate ointment

  42 weeks

Study Arms (2)

Artesunate

EXPERIMENTAL

Drug: Artesunate ointment

Placebo ointment

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Artesunate ointment DRUG

Four 5-day cycles of artesunate ointment given at weeks 0, 2, 4, 6

Also known as: Artesunic acid, Dihydroartemisinin (DHA), Artemisinin

Artesunate

Placebo DRUG

Four 5-day cycles of placebo ointment given at weeks 0, 2, 4, 6

Also known as: placebo ointment

Placebo ointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult men and women age ≥ 18 years
• Capable of informed consent
• Biopsy-confirmed intra-anal high-grade dysplasia (AIN 2, AIN 3, anal HSIL) by HRA.
• Positive anal human papillomavirus (HPV) test.
• Women of childbearing potential agree to use birth control for the duration of the study.
• 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
• Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator.
• Weight ≥ 50kg

You may not qualify if:

• Pregnant and nursing women
• Diagnosis of low-grade anal dysplasia (AIN 1, LSIL), without the concomitant diagnosis of anal HSIL, by HRA
• Concurrent anal, vulvar, cervical, or penile cancer
• HIV-seropositivity
• Currently receiving systemic chemotherapy or radiation therapy for another cancer.
• Patients who are on medical treatment with systemic immunosuppressants or steroids (e.g., active autoimmune disease). Participants using nasal steroid treatments for allergic conditions may participate in the study.
• Concomitant use of strong UGT (Uridine-diphosphate-glucuronosyltransferase) inhibitors
• Concomitant use of imiquimod or 5-fluorouracil (5-FU) for the duration of the study

Sponsors & Collaborators

• Frantz Viral Therapeutics, LLC: lead
• Laser Surgery Care, LLC: collaborator
• Anal Dysplasia Clinic MidWest: collaborator

Study Sites (2)

Anal Dysplasia Clinic MidWest

Chicago, Illinois, 60614, United States

RECRUITING

Laser Surgery Care

New York, New York, 10011, United States

RECRUITING

MeSH Terms

Interventions

artesunic acid; artenimol; artemisinin

Central Study Contacts

Mihaela Plesa

CONTACT

440-255-1155; fvtinfo@frantzgroup.com

Ahmad Bayat, MD

CONTACT

301-956-2523; ahmadb@amarexcro.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind, placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double blind, placebo-controlled randomized trial

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 16, 2024
• Study Start: January 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)