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

12. mai 2026 oppdatert av: 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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

45

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Hong Kong
    • New Territories
      • Shatin, New Territories, Hong Kong
        • Rekruttering
        • Prince of Wales Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kar Kei Yung, MBBS (HK), MRCOG, FHKCOG, FHKA

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Amplexd Therapeutics, Inc.

Samarbeidspartnere

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

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. april 2026

Primær fullføring (Antatt)

27. desember 2026

Studiet fullført (Antatt)

27. januar 2027

Datoer for studieregistrering

Først innsendt

1. mai 2026

Først innsendt som oppfylte QC-kriteriene

1. mai 2026

Først lagt ut (Faktiske)

7. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

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