Artesunate Vaginal Inserts for Cervical Dysplasia (ART-CIN_IIB Trial)

Phase 2

Recruiting

Research Sponsored by Frantz Viral Therapeutics, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women of childbearing potential agree to use birth control through week 28 of the study.

Are you at least 110 pounds?

Must not have

Are you immune compromised in any way?

Are you pregnant or breastfeeding?

Timeline

Screening 6 weeks

Treatment 5 weeks

Follow Up 6 months

Summary

This trial is testing a vaginal insert containing Artesunate for the treatment of CIN2/3 in women. The insert will be compared to a placebo insert to see if it is effective.

Who is the study for?

This trial is for adult women aged 25 or older with a biopsy-confirmed diagnosis of high-grade cervical lesions (CIN2/3), weighing at least 50kg, and not pregnant or breastfeeding. Participants must be able to consent and agree to use birth control until week 28 of the study. Women who are immunocompromised, have concurrent cancer (except nonmelanoma skin lesions), HIV-seropositive, or have active autoimmune diseases cannot join.

What is being tested?

The study is testing Artesunate vaginal inserts versus placebo inserts in treating high-grade cervical pre-cancerous lesions caused by HPV. It's a phase II trial where participants are randomly assigned to receive either the treatment or placebo without knowing which one they're getting.

What are the potential side effects?

While specific side effects for Artesunate vaginal inserts aren't listed here, similar treatments may cause local irritation, discomfort, mild allergic reactions, or systemic effects if absorbed at higher levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to use birth control until week 28 of the study.

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I weigh at least 110 pounds.

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I am a woman aged 25 or older.

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I have been diagnosed with high grade cervical lesions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 6 weeks1 visit

Treatment ~ 5 weeks4 visits

Follow Up ~ 6 months1 visit

Screening ~ 6 weeks

Treatment ~ 5 weeks

Follow Up ~6 months

This trial's timeline: 6 weeks for screening, 5 weeks for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants with histologic regression by week 17

Secondary study objectives

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 have achieved clearance of detectable human papilloma virus (HPV) by week 17

Other study objectives

Number of participants who withdrew from the study due to TEAEs

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