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    Summary
    EudraCT Number:2015-002098-40
    Sponsor's Protocol Code Number:LP0133-1182
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-02
    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 ConcernedGermany - BfArM
    A.2EudraCT number2015-002098-40
    A.3Full title of the trial
    A Phase 2a, Proof of Concept Trial, testing twice daily application of LEO 124249 ointment 30mg/g in the treatment of mild to moderate inverse psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    not applicable
    A.4.1Sponsor's protocol code numberLP0133-1182
    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 pointAnnika Kullberg
    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+4531245908
    B.5.6E-mailannika.kullberg@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 ointment 30 mg/g
    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.3.9.3Other descriptive nameLEO 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
    inverse psoriasis
    E.1.1.1Medical condition in easily understood language
    patients with mild to moderate inverse 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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10063160
    E.1.2Term Inverse psoriasis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of twice daily application of LEO 124249 ointment 30 mg/g and LEO 124249 ointment vehicle for 6 weeks in the treatment of subjects with mild to moderate inverse psoriasis.
    E.2.2Secondary objectives of the trial
    To compare the safety and tolerability of twice daily application of LEO 124249 ointment 30 mg/g and LEO 124249 ointment vehicle for 6 weeks in the treatment of subjects with mild to moderate inverse psoriasis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed and dated informed consent prior to any trial specific procedures.
    2. Male or female subjects between 18 to 75 years.
    3. A diagnosis of stable mild to moderate inverse psoriasis (i.e. axillae, the infra- and intermammary, genital, scrotum, abdominal and retroauricular folds; the intergluteal cleft and perianal skin, in addition to neck or other skin folds). Mild to moderate is defined as having at least score 1 for each individual sign thickness and redness, and total TSS score of at least 5.
    4. The total treatment area can be up to 4% BSA (720 cm2).
    5. Subjects must have a history of psoriasis, or have psoriasis, or present with characteristic psoriasis leasons elsewhere on the body (including the scalp) at Visit 1 (Screening).
    6. Stable inverse psoriasis based on TSS evaluated at Visit 1 (Screening) and at Visit 2 (Start of treatment), which must not differ more than 1 point in any single clinical sign score (redness, scaling and thickness).
    7. Except for inverse psoriasis, overall good health including well controlled diseases (e.g. hypertension, diabetes, and thyroid disease) as determined by medical history, physical examination, electrocardiogram (ECG), vital signs (blood pressure, heart rate and body temperature) and clinical laboratory evaluation.
    8. Subjects willing and able to follow all the trial procedures and complete the whole trial.
    9. Female subjects must be of either:
    o non-childbearing potential, i.e. post-menopausal for at least one year, or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal ligation) or,
    o child-bearing potential (including women less than post menopausal for 1 year) provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy.
    • Female subjects of child-bearing potential (and their male partners) and male subjects (and their female partner of childbearing potential) must be willing to use highly effective methods of contraception (pearl index <1%) from Visits 1 (Screening) and until 1 Week after the last administration of IP. Adequate methods of contraception for female and male are defined as follows:
    • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation for at least one menstrual cycle prior to randomization (Visit 2 (Start of treatment).
    o oral
    o intravaginal
    o transdermal
    • intrauterine device (IUD) for at least one menstrual cycle prior to randomization (Visit 2 Start of treatment).
    • intrauterine hormone-releasing system (IUS) for at least one menstrual cycle prior to randomization (Visit 2 Start of Treatment).
    • bilateral tubal occlusion.
    • vasectomized or vasectomized partner (partner should be sole partner for the subject).
    • sexual abstinence (when this is in line with the preferred lifestyle of the subject).
    E.4Principal exclusion criteria
    1. Female subjects who are breastfeeding or pregnant.
    2. Severe chronic inverse psoriasis, or psoriasis on the body (>30% of BSA).
    3. Current diagnosis of acute guttate, erythrodermic, exfoliative or pustular psoriasis.
    4. Signs of clinically active infection in any of the inverse psoriasis areas, as judged by the investigator.
    5. Disease that has spontaneously and markedly deteriorated or improved between Visit 1 (Screening) and Visit 2 (Start of treatment).
    6. Use of biological therapies (marketed/not marketed) with a possible effect on inverse psoriasis within 4 weeks (etanercept), 8 weeks (adalimumab, alefacept, infliximab), 16 weeks (ustekinumab, secukinumab) or 4 weeks/5 half-lives (whichever is longer) for experimental biological products prior to Visit 2 (Start of treatment).
    7. Use of systemic treatments (marketed/non-marketed), other than biologics, with a potential effect on inverse psoriasis (e.g., corticosteroids, retinoids, dimethylfumarate, cyclosporine, azathioprine methotrexate, immunosuppressants) within 6 weeks prior to Visit 2 (Start of treatment) (inhaled or intranasal steroids corresponding of up to 1 mg prednisone for asthma or rhinitis may be used).
    8. Use of St John’s worth preparations (oral and/or topical) within 2 weeks prior to Visit 2 (Start of treatment).
    9. Use of very potent topical corticosteroids (WHO group IV) for the treatment of psoriasis on the body and/or scalp within 4 weeks prior to Visit 2 (Start of treatment).
    10. Use of topical medication for the treatment of inverse psoriasis: WHO group I-III corticosteroids, retinoids, vitamin D analogues, immunomodulators (e.g. macrolides, calcineurin), anthracen derivatives, tar, or salicylic acid within 2 weeks prior to Visit 2 (Start of treatment).
    11. Exposure to phototherapy (PUVA, UVA, UVB, Grenz Ray therapy) within 4 weeks prior to Visit 2 (Start of treatment).
    12. Use of other treatment (drug/non-drug) for inverse psoriasis during the trial, except for the use of IP.
    13. Initiation of, or expected changes to concomitant medication, that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) within 2 weeks prior to Visit 2 (Start of treatment).
    14. Subjects with a positive HBV score antibody, HBsAg, anti-HCV or anti-HIV test at Visit 1 (Screening) .
    15. Subjects with history of an immunocompromising disease (e.g., lymphoma, HIV, Wiskott-Aldrich Syndrome).
    16. A marked abnormal ECG, i.e. PR interval > 220 ms, QRS interval >110 ms or corrected QT interval (Bazett, QTcB) > 470 ms for females and > 450 ms for males at Visit 1 (Screening).
    17. Supine BP that is over 150/95 mmHg or below 90/50 mmHg at Visits 1 (Screening) and 2 (Start of treatment).
    18. Supine heart rate that is over 100 beats per minute (bpm) or below 50 bpm at Visits 1 (Screening) and 2 (Start of treatment).
    19. Body temperature (ear, tympanic) >37.5 ºC or < 35.5 ºC at Visits 1 (Screening) and 2 (Start of treatment).
    20. Known hepatic dysfunction or hepatic dysfunction tested at Visit 1 (Screening) (e.g. alanine aminotransferase [ALT], aspartate aminotransferase [AST], and gamma glutamyl transpeptidase [GGT] > 2 times the upper limit of normal) .
    21. History of concurrent diseases that could interfere with study evaluations or pose a safety concern.
    22. Any current dermatological disorder (e.g. serborrhic dermatitis, contact dermatitis, cutaneous mycosos) which may confound the evaluation of inverse psoriasis.
    23. Known malignancy (other than cervical carcinoma in situ, basal cell or squamous cell carcinoma) within 5 years before Visit 1 (Screening).
    24. Current participation in any other interventional clinical trial, based on interview of the subject.
    25. Known or suspected hypersensitivity to LEO 124249 or any of the excipients of the investigational products.
    26. Planning of an intensive solar exposure during the trial (vacation, use of solarium/sun lamps) or having been intensely exposed within 2 weeks preceding Visit 1 (Screening).
    27. In the opinion of the investigator, subjects who are, for any reason, unlikely to comply with the Clinical Trial Protocol requirement (e.g. alcoholism, drug dependency or psychological state).
    28. Previous enrolment or randomization into this trial.
    29. Subjects that are under guardianship, hospitalized in a public or private institution for a reason other than research or subject deprived of freedom.
    30. Close affiliation with the investigator (e.g. a close relative) or person working at the trial site, or subject is an en employee of sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    The total sign score (TSS = sum of scores for redness, thickness, and scaliness of inverse psoriasis, each scored from 0 to 4, total sum from 0 to 12) at Week 6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at end of treatment (V6)
    E.5.2Secondary end point(s)
    1. Score for clinical sign redness for inverse psoriasis: (score 0 to 4) at Visit t6 (Week 6).
    2. Score for clinical sign thickness for inverse psoriasis (score 0 to 4) at Visit 6 (Week 6).
    3. Score for clinical sign scaliness for inverse psoriasis: (score 0 to 4) at Visit 6 (Week 6).
    4. Size of treatment area of inverse psoriasis at Visit 6 (Week 6).
    5. Physicians Global Assessment of disease severity (PGA) at Visit 6 (Week 6).
    6. Patients Global Assessment of disease severity (PaGA) Visit 6 (Week 6).
    7. Dermatology Life Quality Index (DLQI) questionnaire at Visit 6 (Week 6).
    8. Treatment satisfaction questionnaire for medication (TSQM II) at Visit 6 (Week 6).
    9. For PGA, the number of subjects reaching controlled disease at Visit 6 (Week 6) (Subjects classified as having at least ‘moderate’ disease at baseline who achieve ‘clear’ or ‘almost clear’ disease severity will be considered to have ‘controlled disease. Subjects classified at baseline as having ‘mild’ disease must achieve ‘clear’ to be considered to have ‘controlled disease’).
    10. For PaGA, the number of subjects reaching controlled disease at Visit 6 (Week 6) (Subjects classified as having at least ‘moderate’ disease at baseline who achieve ‘clear’ or ‘almost clear’ disease severity will be considered to have ‘controlled disease. Subjects classified at baseline as having ‘mild’ disease must achieve ‘clear’ to be considered to have ‘controlled disease’).
    E.5.2.1Timepoint(s) of evaluation of this end point
    at end of treatment (V6)
    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 Yes
    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 concerned11
    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 years0
    E.8.9.1In the Member State concerned months6
    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: 56
    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 state66
    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 Decision2016-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-19
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