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    Summary
    EudraCT Number:2017-004508-23
    Sponsor's Protocol Code Number:EXP-1372
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-12-20
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-004508-23
    A.3Full title of the trial
    Capture of LEO 90100 medication usage with digital tracker and evaluation of efficacy in patients with psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Capture of LEO 90100 medication usage with digital tracker and evaluation of efficacy in patients with psoriasis
    A.4.1Sponsor's protocol code numberEXP-1372
    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 SponsorLEO Pharma A/S
    B.1.3.4CountryDenmark
    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 supportLEO Pharma A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLEO Pharma A/S
    B.5.2Functional name of contact pointHanne Børgesen
    B.5.3 Address:
    B.5.3.1Street AddressIndustriparken 55
    B.5.3.2Town/ cityBallerup
    B.5.3.3Post code2750
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4531506821
    B.5.6E-mailHGNDK@leo-pharma.com
    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 Enstilar®
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameEnstilar / LEO 90100 aerosol foam
    D.3.2Product code LEO 90100
    D.3.4Pharmaceutical form Cutaneous foam
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCalcipotriol
    D.3.9.1CAS number 147657-22-5
    D.3.9.3Other descriptive nameCALCIPOTRIOL MONOHYDRATE
    D.3.9.4EV Substance CodeSUB26081
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBetamethasone diproprionate
    D.3.9.1CAS number 5593-20-4
    D.3.9.3Other descriptive nameBETAMETHASONE DIPROPIONATE
    D.3.9.4EV Substance CodeSUB00783MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    Psoriasis vulgaris
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    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 SOC
    E.1.2Classification code 10040785
    E.1.2Term Skin and subcutaneous tissue disorders
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10050576
    E.1.2Term Psoriasis vulgaris
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To generate adherence and treatment data with LEO 90100 once daily using a tracker.
    E.2.2Secondary objectives of the trial
    To evaluate efficacy of LEO 90100 once daily.

    To evaluate safety and tolerability of LEO 90100 once daily
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For an eligible subject, all inclusion criteria must be answered “yes”.
    1. Signed and dated informed consent has been obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
    2. Age 18 years or above at screening
    3. A clinical diagnosis of psoriasis vulgaris for at least 6 months involving the trunk and/or limbs at screening
    4. Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-15 % of the body surface area (BSA) at screening and enrolment (Day 1)
    5. An Investigator's Global Assessment of disease severity (IGA) of at least ‘mild’ on trunk and limbs at screening and enrolment (Day 1)
    6. A m-PASI score of at least 2 at screening and enrolment (Day 1)
    7. A least one target lesion/target location of at least 3 cm at its longest axis located on the trunk or limbs (i.e., not on the scalp, face or intertriginous areas), scoring at least 1 (‘mild’) for each of redness, thickness and scaliness, and at least 4 in total by the target lesion TSS
    E.4Principal exclusion criteria
    For an eligible subject, all exclusion criteria must be answered “no”.
    1. Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to screening:
    • etanercept – within 4 weeks prior to screening
    • adalimumab, infliximab – within 8 weeks prior to screening
    • ustekinumab – within 16 weeks prior to screening
    • secukinumab – within 12 weeks prior to screening
    • other products – within 4 weeks/5 half-lives prior to screening (whichever is longer)
    2. Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, methotrexate, cyclosporine and other immunosuppressant drugs) within 4 weeks prior to screening
    3. Systemic treatment with apremilast within 4 weeks prior to screening
    4. Subjects who have received treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to screening
    5. Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to screening
    6. Ultraviolet B (UVB) therapy within 2 weeks prior to screening
    7. Topical anti-psoriatic treatment on the trunk and/or limbs (except for emollients) within 2 weeks prior to screening
    8. Topical treatment on the face, scalp and skin folds with corticosteroids (except for emollients, non-steroid medicated shampoos and low potency corticosteroids on sensitive areas), or vitamin D supplements > 400 IU/day within 2 weeks prior to Screening
    a. Stable dose of Vitamin D supplements ≤ 400 IU/Day is permitted
    9. Severe and/or extensive scalp psoriasis which, in the opinion of the investigator, requires treatment with potent or super-potent corticosteroids which will be prohibited during the trial
    10. Pre-existing overt atrophy or telangiectasia in treatment areas
    11. Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors) during the trial
    12. Diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis at screening
    13. Subjects with any of the following conditions present on the treatment area at screening: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, acne vulgaris, atrophic skin, atrophic striae, fragility of skin veins, ichthyosis, acne rosacea, rosacea, ulcers and wounds
    14. Other skin disorders (e.g. seborrheic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis
    15. Planned excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps etc.) of area(s) to be treated with trial medication during the trial
    16. Known or suspected disorders of calcium metabolism associated with hypercalcemia
    17. Known or suspected hypersensitivity to component(s) of medicinal products
    18. Current participation in any other interventional clinical trial
    19. Active substance abuse or a history of substance abuse within 6 months of screening
    20. Language barrier, mental incapacity, unwillingness or inability to adequately understand or comply with trial procedures. (e.g. due to alcoholism, drug addiction or psychotic state).
    21. Subjects who are institutionalized by court order or by local authority.
    22. Subjects in close affiliation with the trial personnel (e.g. immediate family member or subordinate), subjects being a member of the clinical trial personnel, or being an employee of the sponsor or a CRO involved in the trial.
    23. Female subjects who are pregnant, breast feeding or intends to become pregnant or is of childbearing potential* and not using highly effective contraceptive methods** at trial entry and until end of treatment.
    *Female subjects are considered of child-bearing potential unless they have undergone
    hysterectomy, bilateral salpingectomy or bilateral oophorectomy or have been post-menopausal
    for at least one year prior to screening.
    ** Highly effective contraception is defined as follows:
    • Sexual abstinence (when this is in line with the preferred and usual life style of the subject)
    • Vasectomized partner (given that the subject is monogamous)
    • Bilateral tubal occlusion
    • An intrauterine device (IUD)
    • Intrauterine hormone-releasing system (IUS)
    • Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
    • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
    • Surgical sterilised (vasectomy/bilateral tubectomy, hysterectomy and bilateral ovariectomy)
    • Postmenopausal defined as 12 months or more with no menses or alternative medical cause prior to screening.
    E.5 End points
    E.5.1Primary end point(s)
    Patient adherence based on tracker measurements
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to day 29
    E.5.2Secondary end point(s)
    Change from baseline to Day 29 in overall TSS score.
    Subjects achieving ‘treatment success’ (‘clear’ or ‘almost clear’ with at least a 2-grade improvement) according to the IGA at Day 29.
    Treatment emergent AEs (including AEs relating to local tolerability).
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to day 29
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Capture medication usage with a digital tracker
    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 No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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 state60
    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)
    After completion of the trial, the subject will be treated at the investigator's discretion or referred to other physician(s) according to standard practice
    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 Decision2018-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-06-11
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