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

NCT04098744 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: ART-CIN IIB2020 023720 1148
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 7

Brief 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).

Conditions

CIN 2/3; HPV Infection; Pre-Cancerous Dysplasia; Cervical Dysplasia; HPV Related Disease

Keywords

treatment study; cancer prevention; non-surgical; HPV related disease; CIN; topical treatment; vaginal inserts; artesunate; artemisinin; non-invasive; high risk HPV; vaginal suppository

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of participants who have achieved clearance of detectable human papilloma virus (HPV) 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.

  40 weeks

Other Outcomes (2)

• Number of participants with Treatment-Emergent Adverse Events (TEAE)

  6 weeks

• Number of participants who withdrew from the study due to TEAEs

  6 weeks

Study Arms (2)

Artesunate vaginal insert

EXPERIMENTAL

Participants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4.

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.

Drug: Placebo vaginal insert

Interventions

Artesunate vaginal insert DRUG

Artesunate formulated as vaginal inserts, 200mg

Also known as: Artesunic acid, DHA, artemisinin

Artesunate vaginal insert

Placebo vaginal insert DRUG

Placebo for artesunate vaginal inserts

Placebo vaginal inserts

Eligibility Criteria

• Age: 25 Years - 100 Years
• Gender Eligibility Details: This study is for women only as it is a treatment for cervical intraepithelial neoplasia (CIN2/3)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Frantz Viral Therapeutics, LLC: lead
• Amarex Clinical Research: collaborator
• M.D. Anderson Cancer Center: collaborator
• Harris Health System (L.B.J. Hospital): collaborator
• The Cleveland Clinic: collaborator
• University of Michigan: collaborator
• Florida Gynecologic Oncology: collaborator

Study Sites (7)

Florida Gynecologic Oncology

Fort Myers, Florida, 33905, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, 44111, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Hillcrest Hospital

Mayfield Heights, Ohio, 44124, United States

RECRUITING

The Harris Health System (L.B.J Hospital)

Houston, Texas, 77026, United States

RECRUITING

University of Texas, M.D. Anderson

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Dysplasia

Interventions

artesunic acid; artemisinin

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Central Study Contacts

Mihaela Plesa, BA, CCRP

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants, study team, and sponsor are blinded to the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: September 9, 2020
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)