Anal High-grade Squamous Intraepithelial LesionPhase 2ART-AIN IIB-2NCT06206564
Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants
A Phase 2 study testing Artesunate ointment in people with Anal High-grade Squamous Intraepithelial Lesion and Anal HSIL, run by Frantz Viral Therapeutics, LLC at 2 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal High-grade Squamous Intraepithelial Lesion, Anal HSIL, Anal HPV Infection
- What is being tested?
- Artesunate ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Jan 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Anal Dysplasia Clinic MidWest
Chicago, Illinois, 60614
Gary Bucher, MD, 312-623-2625, garybuchermd@adcmidwest.com
Emily Miller, 3126232625
- Recruiting
Laser Surgery Care
New York, New York, 10011
Taylor Ridley, 212-242-6500, tridley@lasersurgerycare.com
Joseph Terlizzi, MD
About this study
Official title: A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Ointment for the Treatment of HIV-negative Patients With Anal High-grade Squamous Intraepithelial Lesions (Anal HSIL)
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)
Read the detailed description
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.
- Being tested
- Artesunate ointment, Placebo
- Keywords
- intra-anal, topical, non-surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate ointmentDrug
Also called Artesunic acid, Dihydroartemisinin (DHA), Artemisinin
Four 5-day cycles of artesunate ointment given at weeks 0, 2, 4, 6
PlaceboDrug
Also called placebo ointment
Four 5-day cycles of placebo ointment given at weeks 0, 2, 4, 6
| Study group | Role | What they receive |
|---|---|---|
| Artesunate | Experimental | Not described Receives: Drug: Artesunate ointment |
| Placebo ointment | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete and partial response by week 18
Number of participants with complete and partial response after four 5-day cycles of artesunate ointment
Measured: 18 weeks
Secondary outcomes (4)
HPV clearance
Number of participants who do not have detectable HPV infection
Measured: 42 weeks
Complete and partial response after week 18
Number of participants with complete and partial response after week 18
Measured: 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
Measured: 42 weeks
Persistence of response
Number of participants who have complete response and do not have recurrence of anal HSIL
Measured: 42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start12 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal High-grade Squamous Intraepithelial LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, placebo-controlled randomized trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frantz Viral Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laser Surgery Care, LLC, Anal Dysplasia Clinic MidWest
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206564
- Sponsor's protocol ID
- ART-AIN IIB-2
- Acronym
- ART-AIN IIB-2
- Status last verified
- May 2025
- First submitted
- 3 Jan 2024
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No protected health information (PHI) will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Ointment for the Treatment of HIV-negative Patients With Anal High-grade Squamous Intraepithelial Lesions (Anal HSIL)
- ClinicalTrials.gov ID
- NCT06206564
- Acronym / sponsor ID
- ART-AIN IIB-2 / ART-AIN IIB-2
- Keywords
- intra-anal, topical, non-surgical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Frantz Viral Therapeutics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Laser Surgery Care, LLC, Anal Dysplasia Clinic MidWest
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double blind, placebo-controlled randomized trial
| Arm | Type | Receives |
|---|---|---|
| Artesunate | Experimental | Drug: Artesunate ointment |
| Placebo ointment | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artesunate ointmentAlso: Artesunic acid, Dihydroartemisinin (DHA), ArtemisininFour 5-day cycles of artesunate ointment given at weeks 0, 2, 4, 6 | Drug | Artesunate |
| PlaceboAlso: placebo ointmentFour 5-day cycles of placebo ointment given at weeks 0, 2, 4, 6 | Drug | Placebo ointment |
Primary outcome
Complete and partial response by week 18
Time frame: 18 weeks
Number of participants with complete and partial response after four 5-day cycles of artesunate ointment
4 secondary outcomes
HPV clearance
Time frame: 42 weeks
Complete and partial response after week 18
Time frame: 30 weeks
Complete and partial peri-anal response after intra-anal ointment application
Time frame: 42 weeks
Persistence of response
Time frame: 42 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No. No protected health information (PHI) will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Artesunate ointment in people with Anal High-grade Squamous Intraepithelial Lesion and Anal HSIL, run by Frantz Viral Therapeutics, LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mihaela Plesa (440-255-1155, fvtinfo@frantzgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete and partial response by week 18 (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.