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    Summary
    EudraCT Number:2016-000870-39
    Sponsor's Protocol Code Number:CHDR1607
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-08-09
    Trial results View 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 number2016-000870-39
    A.3Full title of the trial
    A phase 2, randomized, vehicle-controlled, double-blind study to explore the efficacy, pharmacodynamics and safety of topical ionic contra-viral therapy (ICVT) comprised of digoxin and furosemide in HPV-induced genital lesions of immunocompromised and immunocompetent patients.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Digoxin / Furosemide topical therapy for genital warts and VIN lesions of immunocompromised and immunocompetent patients
    A.4.1Sponsor's protocol code numberCHDR1607
    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 SponsorCutanea Life Sciences
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCutanea Life Science
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre for Human Drug Research
    B.5.2Functional name of contact pointJ. Burggraaf
    B.5.3 Address:
    B.5.3.1Street AddressZernikedreef 8
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CL
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715246400
    B.5.5Fax number+31715246499
    B.5.6E-mailkb@chdr.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 No
    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 nameIonic Contra-Viral Therapy (ICVT) comprised of digoxin and furosemide
    D.3.2Product code CLS003
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDIGOXIN
    D.3.9.1CAS number 20830-75-5
    D.3.9.4EV Substance CodeSUB07135MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.125
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFUROSEMIDE
    D.3.9.1CAS number 54-31-9
    D.3.9.4EV Substance CodeSUB07849MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.125
    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) Yes
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGel
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HPV-induced genital lesions of immunocompromised and immunocompetent patients
    E.1.1.1Medical condition in easily understood language
    Genital warts or Vulval HSIL
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10018182
    E.1.2Term Genital warts
    E.1.2System Organ Class 100000016515
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10064455
    E.1.2Term HSIL
    E.1.2System Organ Class 100000024086
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To explore the pharmacodynamics of the ionic contra-viral therapy CLS003 in immunocompromised and immunocompetent patients with benign and premalignant HPV-induced genital lesions.
    • To evaluate clinical efficacy of CLS003 compared to vehicle in immunocompromised and immunocompetent patients with benign and premalignant HPV-induced genital lesions
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of CLS003 in immunocompromised and immunocompetent patients with benign and premalignant HPV-induced genital lesions
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For enrollment of subjects the following criteria must be met:
    1. Vulvar HSIL or AGW patients, ≥ 18 years of age, in general, stable good health (with the exception of the immunocompromised disorder) as per judgment of the investigator based upon the results of a medical history, physical examination, ECG, chemistry, hematology.
    2. In case of the immunocompromised patient group(s): having an immunosuppressive disease or receiving immunosuppressive therapy for any reason including but not limited to; patients with auto-immune disease, HIV patients, transplantation patients
    3. In case of the genital warts patient group(s): have at least 3 genital warts (only applicable for study part 1).
    4. In case of vulvar HSIL patient group: at least one lesion that can be accurately measured (using RECIST criteria) in at least one dimension with longest diameter ≥20 mm OR in 2 perpendicular dimensions that when multiplied together give a surface area ≥120 mm² (only applicable for study part 1).
    5. If female of childbearing potential, have a negative urine pregnancy test at Screening and Day 0, and is willing to use effective contraception during the study and 3 months afterwards (i.e. oral, implanted, injectable, IUD, diaphragm, condom, tubal ligation, abstinence, or are in a monogamous relationship with a partner who has had a vasectomy)
    6. Able to participate and willing to give written informed consent and to comply with the study restrictions
    7. Ability to communicate well with the investigator in the Dutch language
    8. Willing to refrain from using other topical products in the treatment area, or prohibited medications for the duration of the study
    E.4Principal exclusion criteria
    Eligible subjects must meet none of the following exclusion criteria:
    1. Significant, uncontrolled or unstable disease in any organ system as per judgment of the investigator (regardless of association with the immunosuppressing disorder/therapy), including but not limited to: psychiatric, neurologic, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, endocrine, hematologic or respiratory disease
    2. Have used or received any topical genital wart treatment, cryotherapy, electrocoagulation, surgery in the treatment area within 28 days prior to enrolment
    3. Have used or received any topical vulvar HSIL treatment, laser therapy or surgery in the treatment area within 28 days prior to enrolment
    4. Have any current pathologically relevant skin infections in the treatment area other than genital warts (such as atopic dermatitis, lichen sclerosis, lichen planus or psoriasis)
    5. Have a known sensitivity to any of the investigational product ingredients, including digoxin and furosemide
    6. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year
    7. Loss or donation of blood over 500 mL within three months prior to screening.
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacodynamic / efficacy endpoints
    - For both cohorts:
    • Lesion (vulvar HSIL or wart) size reduction as absolute and percent reduction in lesion diameter as measured by caliper and 3D photography
    • Change in patient-reported outcomes (QoL and patient-reported clearance)
    • HPV viral load assessment (quantitative PCR including HPV genotyping in swabs and biopsies)
    • Change in the HPV viral load (nominal, natural log transformed, and natural log of viral load per DNA copies) as determined by qPCR in swabs and biopsies
    • Mean HPV viral load (nominal, natural log transformed, and natural log of viral load per DNA copies) in swabs and biopsies
    • Histology (regression of vulvar HSIL or AGWs to no dysplasia, HPV genotyping)
    • Local immunity status (Histological changes in immune cells in the mucosa/submucosa)

    - For vulvar HSIL cohort
    • HSIL, size and reduction in lesion size (clinical assessment of lesions by RECIST, absolute reduction in lesion size, lesion size reduction (percentage) as measured by caliper and 3D photograpy
    • Percentage clearance of vulvar HSIL lesions
    • Proportion of subjects will all vulvar HSIL lesions cleared
    • Histology (regression of vulvar HSIL to no dysplasia)
    • Histological recurrence in the Part 1 follow-up period

    - For genital wart cohort:
    • Wart size and reduction in wart size of the target wart (absolute reduction in lesion size, lesion size reduction (percentage)) as measured by caliper and 3D photography
    • Percentage clearance of genital warts
    • Proportion of subjects with all genital warts cleared
    • Clinical recurrence in the Part 1 follow-up period

    Safety and tolerability endpoints
    - Treatment-emergent (serious) adverse events ((S)AEs).
    - Concomitant medication
    - E-diary (Numeric Rating Scale)
    - Clinical laboratory tests
    o Haematology
    o Chemistry
    o Urinalysis
    - Laboratory therapeutic drug monitoring (TDM)
    o Digoxin
    - Vital signs
    o Pulse Rate (bpm)
    o Systolic blood presuure (mmHg)
    o Diastolic blood pressure (mmHg)
    o Temperature
    - Electrocardiogram (ECG)
    o Heart Rate (HR) (bpm), PR, QRS, QT, QTcB, QTcF
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0 - Day 266
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    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: 48
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state48
    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)
    Possible part 2 with extended use of the IMP up to 8 weeks.
    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 Decision2017-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-10-30
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