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    Summary
    EudraCT Number:2014-003688-39
    Sponsor's Protocol Code Number:CLS003-CO-PR-002
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-11-26
    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 number2014-003688-39
    A.3Full title of the trial
    A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Efficacy and Safety of Topical Ionic Contra-viral Therapy (ICVT) Comprised of Digoxin and Furosemide in Cutaneous Warts
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in volunteers with cutaneous warts to assess safety and efficacy of topical ionic contra-viral therapy (ICVT) comprised of digoxin and furosemide.
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and safety of ICVT in healthy volunteers with warts
    A.4.1Sponsor's protocol code numberCLS003-CO-PR-002
    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 Sciences
    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 number0031715246400
    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
    Patients with at least two warts who are otherwise healthy subjects
    E.1.1.1Medical condition in easily understood language
    Patients with at least two warts who are otherwise healthy subjects
    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 17.1
    E.1.2Level LLT
    E.1.2Classification code 10010115
    E.1.2Term Common warts
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10035158
    E.1.2Term Plantar warts
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To assess efficacy of CLS003 in reduction of wart area after six weeks of treatment when applied to cutaneous warts (common or plantar)
    •To evaluate the activity of the ionic contra-viral therapy CLS003, in a HPV biomarker after six weeks of treatment, and after four and eight weeks of post-treatment follow-up, when applied to cutaneous warts (common or plantar), as assessed by cahnges in wart area, wart morphology and HPV quantitative viral load.
    •To evaluate the changes in wart dimensions and morphology relative to the specific HPV genotypes, and HPV viral load at pre-treatment (baseline)

    E.2.2Secondary objectives of the trial
    •To evaluate the safety and tolerability of CLS003 when applied to cutaneous warts for up to six weeks
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive. (Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs,12-lead ECG, haematology, blood chemistry, and urinalysis.);
    2.Body mass index (BMI) between 18 and 30 kg/m2, inclusive;
    3.Fitzpatrick skin type I-II-III-IV;
    4.Capable of tolerating treatment;
    5.Free of clinical significant systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of Adverse Events
    6. Have at least 2 (non-subungual) common warts or at least 2 (non-subungual) plantar warts on non-genital, non-facial skin of which at least 2 are 3mm in diameter in their longest dimensions on the plane of the skin
    7.If female of childbearing potential, have a negative urine pregnancy test at Screening/Day 1, and is willing to use effective contraception during the study (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);
    8.Able to participate and willing to give written informed consent and to comply with the study restrictions;
    9.Ability to communicate well with the investigator in the Dutch language;
    10.Free of any clinical significant systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of Adverse Events;
    11.Willing to refrain from using cosmetics or other topical products in the treatment area, or prohibited medications for the duration of the study;
    12.Agree not to use any wart-removing product (prescription or over-the-counter) other than the study product during the course of the study
    E.4Principal exclusion criteria
    Eligible subjects must meet none of the following exclusion criteria:
    1.Any clinically significant abnormality as determined by medical history taking and physical examinations obtained during the screening visit that in the opinion of the investigator would interfere with the study objectives or compromise subject safety;
    2.For women: a positive pregnancy test and/or nursing at screening or women who plan to become pregnant or are breastfeeding.
    3.A positive test for drugs of abuse at screening;
    4.History of alcohol or illicit drug abuse (alcohol abuse defined as alcohol consumption > 28 units/week);
    5.Positive test results for Hepatitis B, Hepatitis C or HIV;
    6.Have used salicylic acid or any other over-the-counter wart-removing product in the treatment area within 30 days prior to enrolment;
    7.Have received cryotherapy in the treatment area within 60 days prior to enrolment;
    8.Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) within 30 days prior to enrolment or during the course of the study. Routine use of inhaled or intranasal corticosteroids during the study is allowed;
    9.Have any current and / or recurrent pathologically relevant skin infections in the treatment area other than common warts (with the exception of herpes simplex virus labialis);
    10.Have a known sensitivity to any of the investigational product ingredients, including digoxin and furosemide;
    11.Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings at screening that in the opinion of the investigator would interfere with the study objectives or compromise subject safety;
    12.Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year;
    13.Any psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol;
    14.Not having a general practitioner;
    15.Not willing to accept information transfer which concerns participation in the study, or information regarding health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner;
    16.Not willing to give permission to have the general practitioner to be notified upon participation in this study;
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacodynamic effects of CLS003 will be assessed by:
    •Morphological wart assessment on-site;
    •Wart size and morphology assessment by standardized clinical photography;
    •HPV viral load assessment of target lesions by quantitative PCR including HPV genotyping in swabs and biopsies.
    •Percent reduction in wart area at Week 6 to baseline
    •Percent reduction in wart area at follow-up Weeks 10 and 14 to baseline
    •Change in the HPV viral load (nominal, natural log transformed, and natural log of viral load per DNA copies) as determined by qPCR at Weeks 0, 2,4,6, 10 and 14 to baseline
    •Mean HPV viral load (nominal, natural log transformed, and natural log of viral load per DNA copies)at treatment weeks and overall
    •Percent clearance of warts
    E.5.1.1Timepoint(s) of evaluation of this end point
    - PD assessments (wart size, morphology, swabs and photography) will be performed on day 0, 14, 28, 42, 70 and 98.
    - biopsy will be performed at day 98
    - the subjects will keep a treatment diary form day 1 to 42.

    E.5.2Secondary end point(s)
    Adverse events (AE) will be collected throughout the study, at every study visit. Vital signs will be collected at baseline and weeks 2, 4, 6, 10 and 14. Plasma digoxin levels will be determined by therapeutic drug monitoring (TDM) at week 2, week 4 and week 6. ECGs will be performed at screening and week 14 (EOS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    - AEs: continuous from screening until final study evaluation (day 98).
    - Blood samples for clinical laboratory tests will be obtained at
    screening, on day 14, 28 and 42
    - Vital signs will be measured at screening and each visit (multiple
    measurements on day 0, 14, 28, 42, 70 and 98)
    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 No
    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 Yes
    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 trial4
    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 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 years
    E.8.9.1In the Member State concerned months10
    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: 80
    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 state80
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
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