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    Summary
    EudraCT Number:2017-002720-24
    Sponsor's Protocol Code Number:EXP-1377
    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:2017-08-22
    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 number2017-002720-24
    A.3Full title of the trial
    Efficacy of twice daily application of LEO 124249 ointment 30 mg/g for 12
    weeks on eyebrow alopecia areata. Exploratory Phase 2a

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of twice daily application of LEO 124249 ointment 30 mg/g for 12
    weeks on eyebrow alopecia areata. Exploratory Phase 2a

    A.3.2Name or abbreviated title of the trial where available
    Efficacy of twice daily application of LEO 124249 ointment 30 mg/g for 12 weeks on eyebrow alopecia
    A.4.1Sponsor's protocol code numberEXP-1377
    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 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 nameLEO 124249
    D.3.2Product code LEO 124249
    D.3.4Pharmaceutical form Ointment
    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 INNNA
    D.3.9.1CAS number 1263774-59-9
    D.3.9.2Current sponsor codeLEO 124249
    D.3.9.4EV Substance CodeSUB176863
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOintment
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alopecia Areata
    E.1.1.1Medical condition in easily understood language
    Alopecia areata, also known as spot baldness, is a condition in which hair is lost from some or all areas of the body.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of twice daily topical LEO 124249 ointment 30 mg/g compared with LEO 124249 ointment vehicle on hair growth in subjects with Alopecia Areata on eyebrows.
    E.2.2Secondary objectives of the trial
    1. To evaluate safety and tolerability of the treatment with topical LEO 124249 ointment 30 mg/g.
    2. To evaluate the degree of response to treatment (i.e. complete, partial, minimal, none) with twice daily topical LEO 124249 ointment 30 mg/g compared to LEO 124249 ointment vehicle.
    3. To evaluate cosmetic outcome of treatment with twice daily topical LEO 124249 ointment 30 mg/g compared to LEO 124249 ointment vehicle.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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. Clinical unequivocal diagnosis of Alopecia Areata (patchy, univeralis and totalis, on both scalp and eyebrows as assessed by the investigator.
    3. Maximal disease duration of current episode of Alopecia Areata on the eyebrows of 3 years at screening.
    4. Maximal Alopecia Areata disease duration - defined as years of active disease - in other locations than eyebrows of 10 years at screening.
    5. Male or female, age between 18 and 65 years at screening.
    E.4Principal exclusion criteria
    1. Clinical diagnosis of diffuse type alopecia areata as assessed by the investigator.
    2. Any topical, intralesional therapy or procedure applied within 2 cm of the treatment area, within 4 weeks of randomisation, which in the opinion of the investigator, could interfere with the trial assessments. This includes, but is not limited to: corticosteroids, calcineurin inhibitors, calcipotriol, minoxidil, antimicrobials, prostaglandin analogs (e.g. bimatoprost), herbal extracts, topical immunotherapy with allergens or irritants and any laser or phototherapy, and eyebrow tattoo.
    3. The following topical treatments are permitted elsewhere on the body: up to 25g per week of mild to moderate corticosteroids (WHO groups I-III), calcipotriol or calcineurin inhibitors for inflammatory skin conditions (e.g. atopic dermatitis or psoriasis).
    4. Any systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), chloroquin derivatives, corticosteroids (including intralesional treatment outside the trial treatment area), or any other systemic therapy that in the opinion of the investigator could affect hair regrowth, within 4 weeks prior to randomisation.
    5. The following inhaled medications are permitted: the equivalent to 1mg prednisolone used intranasaly or inhaled for rhinitis or asthma.
    6. Systemic JAK inhibitor Ruxolitinib (Jakafi®/Jakavi®), Tofacitinib (Xeljanz®) at any time prior to randomisation.
    7. Ongoing skin infection requiring systemic antimicrobials at randomisation.
    8. Any skin condition, that in the opinion of the investigator, would interfere with the trial specified assessments.
    9. Debute of thyroid disease or change in thyroid medication and/or dose within 6 months of screening.
    10. 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 follow-up visit.
    *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 (estrogen 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)
    E.5 End points
    E.5.1Primary end point(s)
    Investigator evaluated overall area score (AS overall L+R) of eyebrow hair growth
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 12 weeks
    E.5.2Secondary end point(s)
    1. Treatment emergent AEs (including AEs relating to local tolerability)
    2. Degree of response from baseline to treatment at Week 12
    3. Investigator evaluation of cosmetic outcome at Week 12 as assessed by Cosmetic outcome Score
    E.5.2.1Timepoint(s) of evaluation of this end point
    Ad 1. Treatment emergent AE's - at end of study
    Ad 2+3. Other two endpoints - at 12 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 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 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 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 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 months11
    E.8.9.1In the Member State concerned days18
    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: 24
    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 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 state24
    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 Decision2017-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-05-16
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