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

HPV Infection Clinical Trial

— ART-CIN_IIB  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04098744
• Other study ID #: ART-CIN IIB
• Secondary ID: 2020 023720 1148
• Status: Recruiting
• Phase: Phase 2
• Start date: September 9, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Frantz Viral Therapeutics, LLC
• Contact: Mihaela Plesa, BA, CCRP
• Phone: 440-255-1155
• Email: mplesa[@]frantzgroup.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dysplasia
• CIN 2/3
• HPV Infection
• HPV Related Disease
• Papillomavirus Infections
• Pre-Cancerous Dysplasia
• Uterine Cervical Dysplasia

Intervention

Drug:
• Artesunate vaginal insert
Artesunate formulated as vaginal inserts, 200mg
• Placebo vaginal insert
Placebo for artesunate vaginal inserts

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Cleveland Clinic Fairview Hospital	Cleveland	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Florida Gynecologic Oncology	Fort Myers	Florida
United States	The Harris Health System (L.B.J Hospital)	Houston	Texas
United States	University of Texas, M.D. Anderson	Houston	Texas
United States	Hillcrest Hospital	Mayfield Heights	Ohio

Sponsors (7)

Lead Sponsor	Collaborator
Frantz Viral Therapeutics, LLC	Amarex Clinical Research, Harris Health System (L.B.J. Hospital), M.D. Anderson Cancer Center, Morehouse School of Medicine, The Cleveland Clinic, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	6 weeks
Other	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	6 weeks
Primary	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	17 weeks
Secondary	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	17 weeks
Secondary	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	40 weeks