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    Summary
    EudraCT Number:2016-002096-96
    Sponsor's Protocol Code Number:NL57849.068.16
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-09-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-002096-96
    A.3Full title of the trial
    TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia, a multicenter, open-label, non-randomized, controlled study (TOPIC-3 study)
    Imiquimod behandeling van hooggradige CIN-laesies, een multicenter, open-label, niet-gerandomiseerde, gecontroleerde studie (TOPIC-3 studie)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of high-grade Cervical Intraepithelial Neoplasia with imiquimod or surgery.
    Behandeling van hooggradige CIN-laesies met imiquimod of chirurgie.
    A.4.1Sponsor's protocol code numberNL57849.068.16
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMaastricht University Medical Center
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMaastricht University Medical Center
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportMEDA Pharma
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZuyderland MC
    B.5.2Functional name of contact pointDr. M. Weemhoff, MD
    B.5.3 Address:
    B.5.3.1Street AddressHenri Dunantstraat 5
    B.5.3.2Town/ cityHeerlen
    B.5.3.3Post code6419 PC
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031455766515
    B.5.6E-mailm.weemhoff@atriummc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Aldara
    D.2.1.1.2Name of the Marketing Authorisation holderMeda AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameImiquimod
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIMIQUIMOD
    D.3.9.1CAS number 99011-02-6
    D.3.9.4EV Substance CodeSUB12453MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    High-grade Cervical Intraepithelial Neoplasia
    E.1.1.1Medical condition in easily understood language
    Premalignant lesions of the cervix
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objectives:
    - To investigate the efficacy of imiquimod 5% cream for the treatment of CIN2-3 lesions, compared to LLETZ treatment, in selected populations
    - To develop a prediction model for the efficacy of imiquimod treatment in the individual patient, based on biomarkers reflecting host, virus and cellular factors.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    - To assess the incidence and severity of side effects of imiquimod therapy, compared to LLETZ treatment.
    - To assess cytological disease recurrence at 6, 12 and 24 months follow-up, for both treatment groups.
    - To assess Quality of life (QoL) before, during and after treatment for both treatment groups.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - de novo CIN2 or CIN3 lesion, histologically confirmed by diagnostic biopsy
    - age of 18 years or older
    E.4Principal exclusion criteria
    - previous histologically confirmed high-grade CIN (CIN 2–3)
    - concomitant vulvar and/or vaginal intraepithelial neoplasia
    - previous cervical malignancy
    - current malignant disease
    - immunodeficiency (including HIV/AIDS and immunodepressive medication)
    - pregnancy or lactation
    - legal incapability
    E.5 End points
    E.5.1Primary end point(s)
    1. Regression-or-not of CIN2 or CIN 3 lesions after imiquimod therapy defined as regression to CIN 1 or less, at 20 weeks follow-up and adequate treatment of high-grade CIN by LLETZ, defined as no need for additional treatment within 6 months.
    2. A prediction model for treatment efficacy of imiquimod in the individual patient, based on biomarkers reflecting host, virus and cellular factors.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. imiquimod: 20 weeks; LLETZ: 6 months
    2. not applicable
    E.5.2Secondary end point(s)
    1. Side effects of imiquimod therapy and LLETZ therapy as scored by the Common Terminology Criteria for Adverse Events guidelines.
    2. Disease recurrence at 6, 12 and 24 months follow-up, defined as abnormal cervical cytology for all treatment roups.
    3. Quality of life (QoL) before, during and after treatment, assessed by the following QoL questionnaires at 0 and 20 weeks and after 1 year:
    a. Medical Outcomes Study 36-Item Short-Form General Health Survey (RAND 36), to assess generic health-related quality of life
    b. European Organization for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire: QLQ-C30, to assess cancer-specific health-related quality of life
    c. European Organization for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire: QLQ-CX24, to assess cervical cancer specific quality of life, including sexual functioning
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. imiquimod: 20 weeks; LLETZ: 6 weeks
    2. 6, 12 and 24 months
    3. 0, 20 and 52 weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Large Loop Excision of the Transformation Zone
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 140
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state140
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not different from the expected normal treatment of the condition.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-05
    P. End of Trial
    P.End of Trial StatusOngoing
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