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

ConditionsCIN 2/3HPV InfectionPre-Cancerous DysplasiaCervical DysplasiaHPV Related Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age25-100
SponsorFrantz Viral Therapeutics, LLC

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Pregnant and nursing women

Active autoimmune disease

Taking immunosuppressive medication

HIV seropositivity

Trial design

Design model

Parallel

Treatments tested in this trial

  • Artesunate vaginal insert

    Drug

    Artesunate formulated as vaginal inserts, 200mg

  • Placebo vaginal insert

    Drug

    Placebo for artesunate vaginal inserts

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: Artesunate vaginal insertExperimental treatment 1 intervention
Group B: Placebo vaginal insertsPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
17 weeks

Secondary outcomes

1

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

Time frame
17 weeks
2

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

Time frame
40 weeks

Other outcomes

1

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

Time frame
6 weeks
2

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

Time frame
6 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Frantz Viral Therapeutics, LLC

Lead sponsor

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

Source ClinicalTrials.gov
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