Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3) (ART-CIN_IIB)

September 29, 2025 updated by: Frantz Viral Therapeutics, LLC

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Fort Myers, Florida, United States, 33905
        • Recruiting
        • Florida Gynecologic Oncology
        • Principal Investigator:
          • Fadi Abu Shahin, MD
        • Sub-Investigator:
          • Samith Sandadi, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • Diane Harper, MD
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chad Michener, MD
        • Sub-Investigator:
          • Mariam AlHilli, MD
        • Sub-Investigator:
          • Steven Waggonner, MD
        • Sub-Investigator:
          • Robert DeBernardo, MD
        • Sub-Investigator:
          • Roberto Vargas, MD
      • Cleveland, Ohio, United States, 44111
        • Recruiting
        • Cleveland Clinic Fairview Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chad Michener, MD
        • Sub-Investigator:
          • Mariam AlHilli, MD
        • Sub-Investigator:
          • Steven Waggonner, MD
        • Sub-Investigator:
          • Robert DeBernardo, MD
        • Sub-Investigator:
          • Roberto Vargas, MD
      • Mayfield Heights, Ohio, United States, 44124
        • Recruiting
        • Hillcrest Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chad Michener, MD
        • Sub-Investigator:
          • Mariam AlHilli, MD
        • Sub-Investigator:
          • Steven Waggonner, MD
        • Sub-Investigator:
          • Robert DeBernardo, MD
        • Sub-Investigator:
          • Roberto Vargas, MD
        • Sub-Investigator:
          • Lindsey Beffa, MD
    • Texas
      • Houston, Texas, United States, 77026
        • Recruiting
        • The Harris Health System (L.B.J Hospital)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrea Milbourne, MD
        • Sub-Investigator:
          • Kathleen Schmeler, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas, M.D. Anderson
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrea Milbourne, MD
        • Sub-Investigator:
          • Kathleen Schmeler, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Artesunate vaginal insert
Participants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4.
Drug: Artesunate vaginal insert
Artesunate formulated as vaginal inserts, 200mg
Other Names:
  • DHA
  • Artesunic acid
  • artemisinin
Placebo Comparator: Placebo vaginal inserts
Participants will receive three 5-day cycles of placebo vaginal inserts, at week 0, week 2, and week 4.
Drug: Placebo vaginal insert
Placebo for artesunate vaginal inserts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
17 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 17
Time Frame: 17 weeks
Number of participants who had HPV strains detected at study entry which become undetectable by week 17
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
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
40 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Treatment-Emergent Adverse Events (TEAE)
Time Frame: 6 weeks
Number of participants who had adverse events, as defined by CTCAE v5.0, related to the study intervention
6 weeks
Number of participants who withdrew from the study due to TEAEs
Time Frame: 6 weeks
Number of participants who were withdrawn from the study due to adverse events related to the study drug
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Frantz Viral Therapeutics, LLC

Collaborators

M.D. Anderson Cancer Center
University of Michigan
The Cleveland Clinic
Amarex Clinical Research
Harris Health System (L.B.J. Hospital)
Florida Gynecologic Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2020

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 19, 2019

First Submitted That Met QC Criteria

September 19, 2019

First Posted (Actual)

September 23, 2019

Study Record Updates

Last Update Posted (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ART-CIN IIB
  • 2020 0237 (Other Identifier: MD Anderson IRB)
  • 20 1148 (Other Identifier: CCF IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HPV Infection

Clinical Trials on Artesunate vaginal insert

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe