Overview
The goal of this clinical trial is to learn if an investigational vaginal suppository therapy works to treat low-grade cervical lesions (ASC-US and LSIL) associated with high-risk human papillomavirus (hr-HPV) infection in women. It will also learn about the safety and tolerability of this investigational therapy. The main questions it aims to answer are:
- Does the investigational therapy lead to regression of cervical lesions?
- Does the investigational therapy help clear hr-HPV infection?
- Do any adverse effects occur from using this medical product?
Researchers will compare the investigational therapy to a placebo (a look-alike substance that contains no active drug) to see if the investigational therapy works.
Participants will:
- Be screened for hr-HPV, cervical abnormalities, and other conditions to be assessed for eligibility
- Self-administer 15 doses of the investigational therapy or placebo as a vaginal suppository over 19 calendar days
- Attend scheduled clinic visits for examinations, testing, and monitoring for a period of two months
- Undergo assessments to evaluate cervical lesion status, hr-HPV infection, and safety outcomes
- Keep a daily diary of investigational therapy use and associated information
Description
AMP.2025.001 is a Phase II, Double-Blind, randomized, Placebo-Controlled, Proof-of-Concept study to assess the safety and efficacy of Dysplasix™ Intravaginal Suppositories in females with hr-HPV and one of the following: cytologically confirmed (1) Atypical Squamous Cells of Undetermined Significance (ASC-US) or (2) Low-Grade Squamous Intraepithelial Lesions (LSIL)
Participants must undergo both (1) HPV testing and (2) a liquid-based exfoliative cytology test.
If, at laboratory screening, high-risk HPV and either (1) ASC-US or (2) LSIL cytologic abnormalities are detected, participants will be eligible for inclusion. If high-grade SIL (HSIL) or glandular abnormalities (AGC-NOS, AGC-N, AIS) are detected, participants will be excluded.
Eligible participants with high-risk HPV and either (1) ASC-US or (2) LSIL cytology will be randomized in a 1:1 ratio to Dysplasix™ or a matching Placebo until participants who meet eligibility are enrolled. Suppositories (Dysplasix™) or placebo will be intravaginally self-administered once nightly for a fifteen (15) day course of therapy (3 cycles of 5 days followed by two days off between cycles) applied at night immediately before sleep, beginning shortly after the end of menses. Tolerability of the drug will be recorded in daily participant diaries and assessed at regularly scheduled clinical assessment visits.
Participants will undergo complete cervical screening, including hr-HPV testing and cytology 30 (+/- 14) days after completion of treatment in addition to adverse events assessments.
Adverse events are evaluated using Common Terminology Criteria for Adverse Events v5.0.
Eligibility
Inclusion Criteria:
Participants must meet all the following criteria to be eligible to enroll in the study:
- Participants capable of giving informed consent
- Females, ages 18 to 65 years old at the time of signature of the informed consent form.
- Participants who are able to correctly self-administer the intravaginal suppositories
- One or more hr-HPV oncotypes as confirmed by HPV test
- Participants with ASCUS or LSIL abnormalities as confirmed by cytology
- Immune competent
- Participants of childbearing potential must have a negative pregnancy test at screening.
- Participants of childbearing potential must agree to use appropriate contraception or abstain from sexual intercourse for the duration of the study
- Participants must not have received a recent HPV vaccination and must abstain from HPV vaccination until the end of study
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded from the study:
- Presence of HSIL at screening cytology
- Evidence of glandular abnormalities (AGC/AIS) at screening cytology
- BMI below 16
- Pregnant or nursing females
- Evidence of vaginal/vulval comorbidities, specifically, common sexually transmitted or vaginal infections, and bloodborne pathogens
7\. Using a vaginal contraceptive ring
8\. History of irregular menstrual cycles or routine intermenstrual bleeding
9\. Active autoimmune disease
10\. Taking prohibited concomitant medications
11\. Concurrent malignancy except for non-melanoma skin lesions
12\. Active participation in another clinical trial involving therapeutic intervention (unless ending within 30 days of screening date)
