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
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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Trial Manager
- 전화번호: 713-933-9640
- 이메일: p2trialhk@amplexd.com
연구 장소
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New Territories
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Shatin, New Territories, 홍콩
- 모병
- Prince of Wales Hospital
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연락하다:
- Bell (Hei Yi) Yung
- 전화번호: +852 5165 6846
- 이메일: p2trialhk@amplexd.com
-
수석 연구원:
- Kar Kei Yung, MBBS (HK), MRCOG, FHKCOG, FHKA
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
- 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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
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. |
|
위약 비교기: 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.
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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.
기간: From enrollment until post-end of treatment follow up (Day 50 visit)
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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).
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From enrollment until post-end of treatment follow up (Day 50 visit)
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Regression of cervical cytology present at study entry
기간: From enrollment to post-end of treatment follow-up (Day 50 visit)
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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
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From enrollment to post-end of treatment follow-up (Day 50 visit)
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Clearance of hr-HPV genotype present at study entry
기간: From enrollment to post-end of treatment follow-up (Day 50 visit)
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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
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From enrollment to post-end of treatment follow-up (Day 50 visit)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Kar Kei Yung, MBBS (HK), MRCOG, FHKCOG, FHKA, Prince of Wales Hospital, Chinese University of Hong Kong
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- AMP.2025.001
- 200922 (기타 식별자: Hong Kong Department of Health (Pharmacy and Poisons Ordinance))
- 2025.300 (기타 식별자: Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research and Ethics Committee (CREC))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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