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    Summary
    EudraCT Number:2013-001632-21
    Sponsor's Protocol Code Number:M518101-EU04
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-11-18
    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 ConcernedAustria - BASG
    A.2EudraCT number2013-001632-21
    A.3Full title of the trial
    A randomized, double-blind, parallel group phase III multi-center trial to compare twice daily topical application of M518101, Daivonex® and vehicle in patients with plaque psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi-center clinical trial with parallel groups of psoriatic patients receiving different treatments for comparison of a new topical vitamin D3 formulation with the placebo and the marketed comparator Daivonex®
    A.4.1Sponsor's protocol code numberM518101-EU04
    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 SponsorMaruho Europe Limited
    B.1.3.4CountryUnited Kingdom
    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 supportMaruho Europe Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationbioskin GmbH
    B.5.2Functional name of contact pointElisabeth Rowold
    B.5.3 Address:
    B.5.3.1Street AddressBurchardstrasse 17
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code20095
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 406068970
    B.5.5Fax number+49 4060689730
    B.5.6E-mailinfo@bioskin.de
    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 nameM518101 Ointment (pefcalcitol)
    D.3.2Product code M518101
    D.3.4Pharmaceutical form Ointment
    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 INNPefcalcitol
    D.3.9.1CAS number 381212-03-9
    D.3.9.2Current sponsor codeM5181
    D.3.9.4EV Substance CodeSUB06046MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50 µg/g
    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 RoleComparator
    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 Daivonex Ointment
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameDaivonex
    D.3.4Pharmaceutical form Ointment
    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 INNCALCIPOTRIOL
    D.3.9.1CAS number 112828-00-9
    D.3.9.4EV Substance CodeSUB06046MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50 µg/g
    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 placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Plaque psoriasis
    E.1.1.1Medical condition in easily understood language
    Patch type 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 16.1
    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
    The trial is designed with two sequentially assessed primary objectives as described in the EMA guideline (Points to consider on switching between superiority and non-inferiority. EMA, July 2000). For the first stage, the primary objective is to demonstrate that M518101 is non-inferior to Daivonex® in % reduction in mPASI and success rate based on IGA.
    If non-inferiority is demonstrated, the analysis will proceed to the second stage, which is to demonstrate that M518101 is more effective than Daivonex® in the same endpoints. In addition, superiority to Vehicle for both M518101 and Daivonex® will be tested for the same endpoints.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All of the following criteria have to be met for inclusion of a patient in this trial:
    1.Male or female patients aged 18 years or older on the day of signing the ICF;
    2.Signed and dated ICF obtained prior to any trial related activities;
    3.Clinical diagnosis of stable plaque psoriasis of at least 6 months duration (involving the trunk, limbs, palms and/or feet);
    4.Patients who have up to 20% BSA affected with plaques at V1 (screening) and V2 (Wk0-D1) (BSA calculation should not include face/scalp but should include palms of hands and soles of feet);
    5.Patients who are assessed as moderate or severe in IGA at V1 (screening) and V2 (Wk0-D1) and who are suitable for topical therapy;
    6.Women of childbearing potential (less than post-menopausal for two years) should have a negative pregnancy test (serum) at V1 (screening);
    7.Sexually active female patients of childbearing potential (less than post-menopausal for two years), must agree to use documented means of effective birth control (such as oral, transdermal, injectable or implanted hormonal contraceptives; intrauterine device, diaphragm with spermicide, use of a condom by the sexual partner or sterile sexual partner) during the course of the treatment phase; local requirements on contraception are to be followed;
    8.Patients who have at least one psoriatic plaque (minimum size: 10 cm2 in area) of which PSI total score >= 12 (on trunk, arms or legs) at V1 (screening) and V2 (Wk0-D1);
    9.Patients who are capable of understanding and willing to give signed informed consent prior to any protocol specific procedure and are able to complete the trial and comply with protocol instructions.
    E.4Principal exclusion criteria
    Patients are to be excluded from the trial, when one or more of the following conditions are met:
    1.Patients with known allergic reactions, irritations or sensitivity to the active ingredients (history or presence of allergy to vitamin D3 derivatives or presence of relevant drug hypersensitivity) or other components of the investigational products;
    2.Patients who test positive for HIV Ag/Ab, HBs-Ag or HCV-Ab at V1 (screening);
    3.Patients 65 years old or older with serum creatinine levels exceeding the upper limit of reference range at V1 (screening);
    4.Patients who have any renal (serum creatinine level > 1.5 times above the upper limit of reference range) or liver insufficiency (alkaline phosphatase, aspartate aminotransferase, or alanine aminotransferase level > 2.5 fold above upper limit of reference range), or clinically significant cardiac, renal or hepatic disease at V1 (screening);
    5.Patients, who in the opinion of the investigator, have clinically relevant history or presence of any disease, any other skin disorder, any chronic medical condition which is not well controlled or surgical history which may interfere with the conduct of the trial;
    6.Patients who, in the opinion of the investigator, are not deemed eligible as determined by medical history, physical examination (including vital signs), ECG, or clinical laboratory safety tests;
    7.Patients whose calcium test at V1 (screening) exceed the upper limit of reference range (including serum calcium, albumin, phosphate, parathyroid hormone);
    8.Subjects who have at least one of the three QTcF measurements at screening of > 450 msec as shown on the ECG;
    9.Patients who have used M5181 (active ingredient of M518101);
    10.Patients who have used any study drug (including experimental biologics) and/or participated in any clinical trial within the last 60 days before the day of randomization V2 (Wk0-D1);
    11.Patients who have been treated with any biologics for their psoriasis within 30 days or 5 half-lives (whichever is longer) of the biologic before the day of randomization (V2), the longest documented half-life of the biologic should be used to calculate the 5 half-lives;
    12.Patients who have been treated with phototherapy (e.g. PUVA, ultraviolet A [UVA], ultraviolet B [UVB]), laser, oral steroids, oral retinoid, oral immunosuppressive/immunomodulative drugs, cytostatics, cyclosporine or methotrexate within 30 days of randomization V2 (Wk0-D1);
    13.Patients who have been treated with topical steroids, topical immunosuppressive/ immunomodulative drugs, topical vitamin D3 derivative, topical retinoids, anthralin, coal tar (except when used as shampoo, see section 5.4.7) or salicylic acid within 14 days of randomization V2 (Wk0-D1);
    14.Patients treated with medicines which are known to worsen psoriasis (lithium, beta-blockers and chloroquine), except when the patient is on stable dosing with stable psoriatic condition for more than 12 weeks before the day of randomization and remains on stable dose throughout the trial;
    15.Patients who are taking oral vitamin D supplement, except when the patients have been on a stable dose (up to 2,000 IU per day allowed) for at least 56 days (8 weeks) before the day of randomization and plan to continue the dose for the duration of the trial;
    16.Patients taking medicines that affect calcium metabolism (e.g. any oral prescription Vitamin D derivatives, calcium preparations, bisphosphonate, thiazide diuretics or hormone preparation except for oral contraceptives or hormone replacement therapy), except for patients who have been on a stable dose for a period of 84 days (12 weeks) prior to the day of randomization and plan to continue the dose for the duration of the trial;
    17.Patients who are pregnant, breast-feeding or of childbearing potential and who plan to become pregnant during the trial;
    18.Contraindications according to summary of product characteristics of the active comparator (Daivonex® ointment) (see section 3.2.2);
    19.Patient is institutionalized because of legal or regulatory order.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoints (Co-Primary)
    -% reduction in mPASI at V7 (Wk8-D57) compared to baseline
    -Success rate based on IGA at V7(Wk8-D57)
    E.5.1.1Timepoint(s) of evaluation of this end point
    - V7(Wk8-D57) compared to baseline (Visit 2 / Week 0 / Day 1)
    - V7(Wk8-D57)
    E.5.2Secondary end point(s)
    Secondary endpoints
    -mPASI50 rate at V7 (Wk8-D57)
    -mPASI75 rate at V7 (Wk8-D57)
    -Change in psoriasis severity index (PSI) total score at V7 (Wk8-D57) compared to baseline
    -% reduction in mPASI at V2 (Wk1-D8) compared to baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Visit 7 (Week 8 / Day 57)
    - Visit 7 (Week 8 / Day 57) compared to baseline (Visit 2 / Week 0 / Day 1)
    - Visit 2 (Week 1 / Day 8) compared to baseline (Visit 2 / Week 0 / Day 1)
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Bulgaria
    Germany
    Hungary
    Lithuania
    Poland
    Romania
    Ukraine
    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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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.1.3Elderly (>=65 years) Yes
    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 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 555
    F.4.2.2In the whole clinical trial 725
    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)
    Patients will be treated as per usual standard of care following completion of the study



    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 Decision2014-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-07
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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