RecruitingPhase 2NCT07572396

Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic Abnormalities

A Phase II, Randomized, Double-blind, Placebo-Controlled, Proof of Concept Study to Assess the Safety and Efficacy of Dysplasix™ Intravaginally-Administered Suppositories in Patients With High-Risk Human Papillomavirus (Hr-HPV) as Determined by HPV Testing, and Accompanied by Either (1) Atypical Squamous Cells of Undetermined Significance (ASC-US) or (2) Low-Grade Squamous Intraepithelial Lesions (LSIL), as Determined by Cytology

Sponsor

Amplexd Therapeutics, Inc.

Enrollment

45 participants

Start Date

Apr 30, 2026

Study Type

INTERVENTIONAL

Conditions

HPV Infection ASC-US Uterine Cervical Dysplasia High-risk HPV (Any Strain)LSIL, Low Grade Squamous Intraepithelial Lesion Cervical Abnormalities

Summary

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

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Inclusion Criteria10

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 Criteria12

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
\. Using a vaginal contraceptive ring
\. History of irregular menstrual cycles or routine intermenstrual bleeding
\. Active autoimmune disease
\. Taking prohibited concomitant medications
\. Concurrent malignancy except for non-melanoma skin lesions
\. Active participation in another clinical trial involving therapeutic intervention (unless ending within 30 days of screening date)

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Interventions

DRUGEGCG and Quinine Sulfate Vaginal Suppository

Epigallocatechin gallate 50mg + Quinine Sulfate 50mg - Dysplasix™ Semisolid Intravaginal suppository 15 doses administered over the span of 3 x 5 consecutive nightly administration of investigational therapy, followed by a two day pause between cycles for a total of 15 doses administered over 19 calendar days. If menses occurs during treatment, investigational product use should be suspended until menses seizes and continued thereafter until 15 doses have been administered.

OTHERPlacebo

Semisolid Intravaginal Suppository 15 doses administered over the span of 3 x 5 consecutive nightly administration of investigational therapy, followed by a two day pause between cycles for a total of 15 doses administered over 19 calendar days. If menses occurs during treatment, investigational product use should be suspended until menses seizes and continued thereafter until 15 doses have been administered.