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

12. maj 2026 opdateret af: Amplexd Therapeutics, Inc.

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

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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

45

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Hong Kong
    • New Territories
      • Shatin, New Territories, Hong Kong
        • Rekruttering
        • Prince of Wales Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Kar Kei Yung, MBBS (HK), MRCOG, FHKCOG, FHKA

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

Participants must meet all the following criteria to be eligible to enroll in the study:

  1. Participants capable of giving informed consent
  2. Females, ages 18 to 65 years old at the time of signature of the informed consent form.
  3. Participants who are able to correctly self-administer the intravaginal suppositories
  4. One or more hr-HPV oncotypes as confirmed by HPV test
  5. Participants with ASCUS or LSIL abnormalities as confirmed by cytology
  6. Immune competent
  7. Participants of childbearing potential must have a negative pregnancy test at screening.
  8. Participants of childbearing potential must agree to use appropriate contraception or abstain from sexual intercourse for the duration of the study
  9. 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:

  1. Presence of HSIL at screening cytology
  2. Evidence of glandular abnormalities (AGC/AIS) at screening cytology
  3. BMI below 16
  4. Pregnant or nursing females
  5. Evidence of vaginal/vulval comorbidities, specifically, common sexually transmitted or vaginal infections, and bloodborne pathogens
  6. Using a vaginal contraceptive ring
  7. History of irregular menstrual cycles or routine intermenstrual bleeding
  8. Active autoimmune disease
  9. Taking prohibited concomitant medications
  10. Concurrent malignancy except for non-melanoma skin lesions
  11. Active participation in another clinical trial involving therapeutic intervention (unless ending within 30 days of screening date)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dysplasix™ Intravaginal Suppositories
Epigallocatechin gallate + Quinine Sulfate - 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.
Medicin: EGCG and Quinine Sulfate Vaginal Suppository

Epigallocatechin gallate + Quinine Sulfate - 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.
Placebo komparator: Placebo Intravaginal Suppositories
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.
Andet: Placebo

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To determine and evaluate the safety and tolerability of Dysplasix™ intravaginal suppository therapy in females with hr-HPV and positive cytology for either ASCUS or LSIL.
Tidsramme: From enrollment until post-end of treatment follow up (Day 50 visit)
Number of participants with serious adverse events (SAEs) or dose-limiting toxicities (DLTs) related to the study intervention assessed using relevant Common Terminology Criteria for Adverse Events (CTCAE).
From enrollment until post-end of treatment follow up (Day 50 visit)
Regression of cervical cytology present at study entry
Tidsramme: From enrollment to post-end of treatment follow-up (Day 50 visit)
Participants whose baseline Atypical Cells of Undetermined Significance (ASCUS) or Low-Grade Squamous Intraepithelial Lesions (LSIL) regress to Normal for Intraepithelial Lesions or Malignancies (NILM), 30 days after completion of 15-day course of Dysplasix™ therapy (3 x 5-day cycles), as assessed by cytology
From enrollment to post-end of treatment follow-up (Day 50 visit)
Clearance of hr-HPV genotype present at study entry
Tidsramme: From enrollment to post-end of treatment follow-up (Day 50 visit)
Participants whose high-risk human papillomavirus (HPV) genotypes present at study entry become undetectable 30 days after completion of 15-day course of Dysplasix™ therapy (3 x 5-day cycles), as assessed by HPV testing
From enrollment to post-end of treatment follow-up (Day 50 visit)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Amplexd Therapeutics, Inc.

Samarbejdspartnere

Chinese University of Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong

Efterforskere

  • Ledende efterforsker: Kar Kei Yung, MBBS (HK), MRCOG, FHKCOG, FHKA, Prince of Wales Hospital, Chinese University of Hong Kong

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. april 2026

Primær færdiggørelse (Anslået)

27. december 2026

Studieafslutning (Anslået)

27. januar 2027

Datoer for studieregistrering

Først indsendt

1. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. maj 2026

Først opslået (Faktiske)

7. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AMP.2025.001
  • 200922 (Anden identifikator: Hong Kong Department of Health (Pharmacy and Poisons Ordinance))
  • 2025.300 (Anden identifikator: Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research and Ethics Committee (CREC))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

The sponsor is in the process of finalizing an IPD sharing policy and governance framework.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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