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

Sponsor: Frantz Viral Therapeutics, LLC

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04098744

Patient View

This phase II study evaluates artesunate vaginal inserts for treating CIN2/3. Participants are randomized 2:1 to receive artesunate or placebo over three 5-day cycles. Eligibility includes adult females ≥25 years with confirmed CIN2/3. Exclusions include pregnancy, autoimmune disease, and immunosuppression. The primary goal is to assess histopathologic response, with safety and viral clearance as secondary objectives.

Patient Parameters

Program Overview

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

Eligibility Criteria

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

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