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    Summary
    EudraCT Number:2015-005279-25
    Sponsor's Protocol Code Number:LP0058-1072
    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:2016-02-10
    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 number2015-005279-25
    A.3Full title of the trial
    LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris
    A phase 2a proof of concept study comparing an oral tablet formulation of LEO 32731 with a corresponding placebo tablet in patients with moderate to severe psoriasis vulgaris
    A multi-centre, prospective, randomized, double-blind, 2-arm, placebo-controlled, parallel-group study with 16 weeks twice times daily oral treatment

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to evaluate the efficacy of LEO 32731 oral tablet formulation in patients with moderate to severe psoriasis vulgaris.
    A.3.2Name or abbreviated title of the trial where available
    LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris
    A.4.1Sponsor's protocol code numberLP0058-1072
    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 pointGlobal Clinical Operation
    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+45 44945888
    B.5.6E-mailrlfdk@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 32731 tablet 10 mg
    D.3.2Product code LEO 32731
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot applicable
    D.3.9.1CAS number 1353546-86-7
    D.3.9.2Current sponsor codeLEO 32731
    D.3.9.3Other descriptive nameLEO 32731
    D.3.9.4EV Substance CodeSUB122622
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 2
    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 32731 tablet 30 mg
    D.3.2Product code LEO 32731
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot applicable
    D.3.9.1CAS number 1353546-86-7
    D.3.9.2Current sponsor codeLEO 32731
    D.3.9.3Other descriptive nameLEO 32731
    D.3.9.4EV Substance CodeSUB122622
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Psoriasis Vulgaris
    Schuppenflechte
    E.1.1.1Medical condition in easily understood language
    Psoriasis is an immunologic disease causing inflammation, scaling and redness of the skin, located mainly on the scalp, sides of elbows and knees, and the sacral region.
    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 10050576
    E.1.2Term Psoriasis vulgaris
    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 investigate the efficacy of LEO 32731 30 mg as compared to placebo after 16 weeks of oral treatment of psoriasis vulgaris.
    E.2.2Secondary objectives of the trial
    To investigate the effect on psoriasis symptoms during 16 weeks of twice daily treatment with 30 mg of LEO 32731 and LEO 32731 placebo.
    To investigate the effect on itch intensity after 16 weeks of twice daily treatment with 30 mg of LEO 32731 and LEO 32731 placebo.
    To investigate the safety and tolerability during 16 weeks of twice daily treatment with 30 mg of LEO 32731 and LEO 32731 placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Clinical diagnosis of psoriasis vulgaris with or without psoriatic arthritis (max. of 4 joints with active arthritis ) for at least 6 months prior to Screening Visit 2 (SV2).
    • Have moderate to severe psoriasis vulgaris at SV2 and Visit 1 as defined by:
    a. Psoriasis Area and Severity Index (PASI) > 10 and
    b. Covering > 10% of the body surface area (BSA) and
    c. Disease severity of moderate or worse (PGA ≥ 3) according to the Physician´s Global Assessment of disease severity (PGA).
    • Candidates of systemic anti-psoriatic treatment and/or phototherapy.
    • Female subjects must be of non-childbearing potential, i.e. post-menopausal for at least 1 year, or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or have undergone tubal litigation)
    • Male subjects with pregnant partner or with partners of childbearing potential must be willing to use a condom until end of trial, including the 2 weeks follow up period.
    E.4Principal exclusion criteria
    • Subjects with therapy resistant psoriasis defined as: Two or more treatment failures due to inadequate efficacy within the past 5 years of the following treatment classes (systemic therapies) administered in adequate dose and duration according to the label or guidelines (local/national). Subjects who stopped systemic treatment for reasons not related to lack of efficacy should not be excluded
    a. Oral systemic therapies including but not limited to methotrexate, cyclosporine, retinoids, corticosteroids, apremilast and fumaric acid
    b. Biological therapies including but not limited to etanercept, secukinumab, adalimumab, infliximab and ustekinumab
    c. Light therapy (PUVA and UVB).
    • Previously exposed to apremilast.
    • Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to Visit 1:
    a. Etanercept – 4 weeks
    b. Adalimumab, certolizumab and infliximab – 2 months
    c. Ustekinumab and secukinumab – 4 months.
    • Systemic treatment with all other therapies (other than biologics) with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants, methotrexate, cyclosporine or fumaric acid) within 4 weeks or 5 half-lives (whichever is longer) prior to Visit 1.
    • Use of anticoagulants/antiplatelets (e.g., warfarin, clopidogrel or ticlopidine) within 4 weeks prior to Visit 1.
    • Use of topical antibiotics within 2 weeks prior to Visit 1 (short term use of systemic antibiotics are allowed).
    • Light therapy (PUVA or UVB) within 4 weeks prior to Visit 1.
    • Any topical treatment (except for emollients/non-steroid medicated shampoo) within 2 weeks prior to Visit 1.
    • Initiation of, or changes of doses to concomitant medication that could affect psoriasis vulgaris (e.g., beta-blockers, ACE inhibitors, anti-malaria drugs, lithium) within 4 weeks prior to Visit 1 and throughout the trial.
    • Concomitant medication that are metabolized via cytochrome P 450 3A4 isozyme (Appendix 5) within 4 weeks prior to Visit 1, during the treatment period and during follow-up.
    • Current diagnosis with guttate, erythrodermic, exfoliative or pustular psoriasis, or other skin conditions that may confound the evaluation of psoriasis vulgaris as judged by the Investigator.
    • Subjects with a positive HBV core antibody, HBsAg, anti-HCV or anti-HIV test at SV2.
    • ALT or AST >2.5 x ULN at SV2.
    • Serum creatinine ≥1.5 mg/dl at SV2. For a subject with a value of ≥1.5 mg/dl, a creatinine clearance of ≥60 mL/min using a Cockroft-Gault formula will be allowed.
    • Overt Proteinuria (defined as ≥ +2 on urine dipstick) as deemed clinically significant at SV2.
    • Two consecutive measurements of supine systemic blood pressure >150/95 mmHg or <90/50 mmHg at SV2 taken 5 minutes apart.
    •A marked baseline prolongation of a QTcF interval > 450 ms for males and > 470 ms for females or PR interval >220 ms or QRS interval > 110 ms or a clinically significant ECG at SV2.
    • Clinically significant cardiac, endocrinologic, pulmonary, neurologic, hepatic, renal, haematologic, or gastrointestinal disease, immunologic insufficiency, or other major diseases or current condition which, in the opinion of the Investigator, makes the subject unable to participate in the trial, or a current or a history of major depressive disorder within the last 5 years, or any depressive disorder within last 12 months, or another significant psychiatric disorder within the last 12 months.
    • A laboratory value obtained at SV2 that is outside the normal range and is deemed to be clinically significant.
    •Planned exposure to the sun during the trial that may affect psoriasis vulgaris (i.e., normal lifestyle outdoor activities are permitted but deliberate exposure to sunlight or artificial ultraviolet light should be avoided).
    • Donation of blood within 3 months before Visit 1 and during the course of the trial.
    • Planned surgery (except dermatological procedure) within 4 weeks before Visit 1 and during the course of the trial.
    • Alcohol consumption of more than 21 units/week for males and 14 units/week for females (1 unit = a small bottle of beer or a small glass of wine) during the course of the trial or subjects with a significant history of alcoholism or drug/chemical abuse.
    • Active Tuberculosis or history of incompletely treated tuberculosis.
    • Known malignancy (other than treated cervical carcinoma in situ and treated localized basal cell or skin squamous cell carcinoma) within the 5 year period prior to Visit 1.
    • Vaccinated with live vaccine within the 4 weeks prior to Visit 1 or during the course of the trial.
    • Known or suspected hypersensivity to component(s) of the investigational product. Known Galactosaemia (deficiency of galactose-1-phosphate uridyltransferase or UDP-galactose-4-epimerase or galactokinase; Fanconi-Bickel syndrome), congenital lactose deficiency, glucose-galactose malabsorption.
    E.5 End points
    E.5.1Primary end point(s)
    PASI
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 16
    E.5.2Secondary end point(s)
    PGA treatment success (defined as “Clear” or “Almost Clear”) according to PGA at week 16
    Itch evaluated by Itch NRS at week 16
    E.5.2.1Timepoint(s) of evaluation of this end point
    PGA treatment success : week 16
    Itch evaluated by Itch NRS: week 16
    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 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 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 concerned8
    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 years
    E.8.9.1In the Member State concerned months16
    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: 36
    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 state36
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-06
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