CIN 2/3Phase 2ART-CIN_IIBNCT04098744
Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
A Phase 2 study testing Artesunate vaginal insert in people with CIN 2/3 and HPV Infection, run by Frantz Viral Therapeutics, LLC at 7 sites in United States.
Trial summary
This is a phase II double blind, placebo-controlled, randomized study of Artesunate vaginal inserts for the treatment of women who have cervical high grade intraepithelial neoplasia (CIN2/3). Read more about this study
- Who is it for?
- Ages 25 to 100 years, women only
- Conditions the study is for
- CIN 2/3, HPV Infection, Pre-Cancerous Dysplasia
- What is being tested?
- Artesunate vaginal insert
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 7 sitesUnited States
- Study dates
- 9 Sep 2020to 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 25 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult females age ≥ 25 years
- Capable of informed consent
- Any HPV genotype detectable by DNA test/HPV genotyping
- Colposcopically-directed, histologically confirmed tissue diagnosis of cervical high grade squamous intraepithelial lesions (CIN2, CIN3, or CIN2/3)
- Women of childbearing potential agree to use birth control through week17 of the study.
- Weight ≥ 50kg
Who cannot join
- Pregnant and nursing women
- Active autoimmune disease
- Taking immunosuppressive medication
- HIV seropositivity
- Immunocompromised subjects
- Evidence of concurrent cervical adenocarcinoma in situ
- Concurrent malignancy except for nonmelanoma skin lesions, because treatment for other cancers have systemic effects
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Mubeenah Syedah, 734-998-6349, symubeen@med.umich.edu
Diane Harper, MD
- Recruiting
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, 44111
Donna White, 216-445-8090, whited11@ccf.org
Megan Park, 216-445-8090, parkm2@ccf.org
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Donna White, 216-445-8090, whited11@ccf.org
Megan Park, 216-445-8090, parkm2@ccf.org
- Recruiting
Florida Gynecologic Oncology
Fort Myers, Florida, 33905
Cami Hansen, 239-334-6626, cami.hansen25@gmail.com
Fadi Abu Shahin, MD
- Recruiting
The Harris Health System (L.B.J Hospital)
Houston, Texas, 77026
Jessica Gallegos, 713-563-4580, jrgalleg@mdanderson.org
Cindy Melendez, 713-563-4582, cvmelend@mdanderson.org
- Recruiting
University of Texas, M.D. Anderson
Houston, Texas, 77030
Jessica Gallegos, 713-563-4580, jrgalleg@mdanderson.org
Cindy Melendez, 713-563-4582, cvmelend@mdanderson.org
- Recruiting
Hillcrest Hospital
Mayfield Heights, Ohio, 44124
Donna White, 216-445-8090, whited11@ccf.org
Megan Park, 216-445-8090, parkm2@ccf.org
About this study
Official title: A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)
This is a phase II double blind, placebo-controlled, randomized study of Artesunate vaginal inserts for the treatment of women who have cervical high grade intraepithelial neoplasia (CIN2/3).
Read the detailed description
Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo vaginal inserts for the treatment of CIN2/3. Both groups receive three 5-day cycles of the respective drug, at weeks 0, 2, and 4. Dosing visits can be done as telehealth visits (medication is mailed to the patient's home). Participants are followed after receiving artesunate at weeks 6, 17, and 40. All participants undergo a LEEP procedure at week 17.
Primary Objective: To evaluate the histopathologic response to three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3.
Secondary Objectives:
- To evaluate the safety of artesunate vaginal inserts for the treatment of CIN2/3
- To evaluate the viral clearance after three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3.
- To evaluate viral clearance after three 5-day cycles of artesunate and the LEEP procedure
- Being tested
- Artesunate vaginal insert, Placebo vaginal insert
- Keywords
- treatment study, cancer prevention, non-surgical, HPV related disease, CIN, topical treatment, vaginal inserts, artesunate, artemisinin, non-invasive, high risk HPV, vaginal suppository
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate vaginal insertDrug
Also called Artesunic acid, DHA, artemisinin
Artesunate formulated as vaginal inserts, 200mg
Placebo vaginal insertDrug
Placebo for artesunate vaginal inserts
| Study group | Role | What they receive |
|---|---|---|
| Artesunate vaginal insert | Experimental | Participants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4. Receives: Drug: Artesunate vaginal insert |
| Placebo vaginal inserts | Placebo comparator | Participants will receive three 5-day cycles of placebo vaginal inserts, at week 0, week 2, and week 4. Receives: Drug: Placebo vaginal insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with histologic regression by week 17
Number of participants who undergo histologic regression to cervical intraepithelial neoplasia (CIN) 1 or less by week 17, following three 5-day cycles of artesunate vaginal inserts, as determined by the LEEP histopathologic analysis
Measured: 17 weeks
Secondary outcomes (2)
Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 17
Number of participants who had HPV strains detected at study entry which become undetectable by week 17
Measured: 17 weeks
Number of participants who have achieved clearance of detectable human papilloma virus (HPV) after three 5-day cycles of artesunate and the LEEP procedure.
Number of participants who had HPV strains detected at study entry which become undetectable after three 5-day cycles of artesunate and the LEEP procedure
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start9 Sep 2020
- Primary completion31 Jul 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 CIN 2/3Studies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frantz Viral Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research, M.D. Anderson Cancer Center, Harris Health System (L.B.J. Hospital), The Cleveland Clinic, University of Michigan, Florida Gynecologic Oncology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098744
- Sponsor's protocol ID
- ART-CIN IIB
- Other IDs
- 2020 0237, 20 1148
- Acronym
- ART-CIN_IIB
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2019
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 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 Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)
- ClinicalTrials.gov ID
- NCT04098744
- Acronym / sponsor ID
- ART-CIN_IIB / ART-CIN IIB
- Keywords
- treatment study, cancer prevention, non-surgical, HPV related disease, CIN, topical treatment, vaginal inserts, artesunate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Frantz Viral Therapeutics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research, M.D. Anderson Cancer Center, Harris Health System (L.B.J. Hospital), The Cleveland Clinic, University of Michigan, Florida Gynecologic Oncology
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Sep 2019 (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 vaginal inserts for the treatment of women who have cervical high grade intraepithelial neoplasia (CIN2/3).
Detailed description
Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo vaginal inserts for the treatment of CIN2/3. Both groups receive three 5-day cycles of the respective drug, at weeks 0, 2, and 4. Dosing visits can be done as telehealth visits (medication is mailed to the patient's home). Participants are followed after receiving artesunate at weeks 6, 17, and 40. All participants undergo a LEEP procedure at week 17.
Primary Objective: To evaluate the histopathologic response to three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3.
Secondary Objectives:
- To evaluate the safety of artesunate vaginal inserts for the treatment of CIN2/3
- To evaluate the viral clearance after three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3.
- To evaluate viral clearance after three 5-day cycles of artesunate and the LEEP procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artesunate vaginal insert | Experimental | Drug: Artesunate vaginal insertParticipants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4. |
| Placebo vaginal inserts | Placebo comparator | Drug: Placebo vaginal insertParticipants will receive three 5-day cycles of placebo vaginal inserts, at week 0, week 2, and week 4. |
Who may qualify
- Ages
- 25 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult females age ≥ 25 years
- Capable of informed consent
- Any HPV genotype detectable by DNA test/HPV genotyping
- Colposcopically-directed, histologically confirmed tissue diagnosis of cervical high grade squamous intraepithelial lesions (CIN2, CIN3, or CIN2/3)
- Women of childbearing potential agree to use birth control through week17 of the study.
Key exclusion criteria (7 listed)
- Pregnant and nursing women
- Active autoimmune disease
- Taking immunosuppressive medication
- HIV seropositivity
- Immunocompromised subjects
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 vaginal insertAlso: Artesunic acid, DHA, artemisininArtesunate formulated as vaginal inserts, 200mg | Drug | Artesunate vaginal insert |
| Placebo vaginal insertPlacebo for artesunate vaginal inserts | Drug | Placebo vaginal inserts |
Primary outcome
Proportion of participants with histologic regression by week 17
Time frame: 17 weeks
Number of participants who undergo histologic regression to cervical intraepithelial neoplasia (CIN) 1 or less by week 17, following three 5-day cycles of artesunate vaginal inserts, as determined by the LEEP histopathologic analysis
2 secondary outcomes
Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 17
Time frame: 17 weeks
Number of participants who have achieved clearance of detectable human papilloma virus (HPV) after three 5-day cycles of artesunate and the LEEP procedure.
Time frame: 40 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 2 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for CIN 2/3
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PVX4 for the Treatment of Human Papilloma Virus (HPV)16+ Cervical Dysplasia
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A Study to Assess the Reduction of Human Papillomavirus (HPV) Viral Infectivity and Transmission in HPV-Positive Women After Vaccination With 9vHPV (RIFT-HPV)
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CIN 2/3
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.
7 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 vaginal insert in people with CIN 2/3 and HPV Infection, run by Frantz Viral Therapeutics, LLC at 7 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 6 inclusion and 7 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 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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, BA, CCRP (440-255-1155 ext. 100, FVTinfo@frantzgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with histologic regression by week 17 (time frame: 17 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 2 Oct 2025.