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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Trial Manager
- 電話番号：713-933-9640
- メール：p2trialhk@amplexd.com
研究場所
-
-
New Territories
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Shatin、New Territories、香港
- 募集
- Prince of Wales Hospital
-
コンタクト：
- Bell (Hei Yi) Yung
- 電話番号：+852 5165 6846
- メール：p2trialhk@amplexd.com
-
主任研究者：
- Kar Kei Yung, MBBS (HK), MRCOG, FHKCOG, FHKA
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
プラセボコンパレーター：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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.
時間枠：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
時間枠：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)
|
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Clearance of hr-HPV genotype present at study entry
時間枠：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)
|
協力者と研究者
捜査官
- 主任研究者：Kar Kei Yung, MBBS (HK), MRCOG, FHKCOG, FHKA、Prince of Wales Hospital, Chinese University of Hong Kong
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- AMP.2025.001
- 200922 (その他の識別子：Hong Kong Department of Health (Pharmacy and Poisons Ordinance))
- 2025.300 (その他の識別子：Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research and Ethics Committee (CREC))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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