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

Frantz Viral Therapeutics

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: Artesunate vaginal insert; Drug: Placebo vaginal insert

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04098744

2020 0237 (Other Identifier)

20 1148 (Other Identifier)

ART-CIN IIB

Details and patient eligibility

About

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).

Full 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

Enrollment: 78 estimated patients

Sex: Female

Ages: 25 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 2 patient groups, including a placebo group

Artesunate vaginal insert

Experimental group

Description:

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

Treatment:

Drug: Artesunate vaginal insert

Placebo vaginal inserts

Placebo Comparator group

Description:

Participants will receive three 5-day cycles of placebo vaginal inserts, at week 0, week 2, and week 4.

Treatment:

Drug: Placebo vaginal insert