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    Summary
    EudraCT Number:2018-004010-18
    Sponsor's Protocol Code Number:M-41008-47
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-03-29
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2018-004010-18
    A.3Full title of the trial
    An Open Label, Multi-Center, 24 Week, Exploratory Study to Assess the
    Efficacy and Safety of Skilarence® (Dimethyl Fumarate) in Patients with
    Moderate Plaque Psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Use Of Skilarence® To Treat Patients With Moderate Plaque Psoriasis
    A.4.1Sponsor's protocol code numberM-41008-47
    A.5.4Other Identifiers
    Name:CRONumber:SMR-3612
    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 SponsorAlmirall Ltd.
    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 supportAlmirall Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSmerud Medical Research UK, Ltd
    B.5.2Functional name of contact pointDr. Amanda Knock
    B.5.3 Address:
    B.5.3.1Street AddressSuite 1S-B Trafford House, Chester road
    B.5.3.2Town/ cityManchester
    B.5.3.3Post codeM32 0RS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44016187708129
    B.5.6E-mailregulatory.uk@smerud.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 Skilarence
    D.2.1.1.2Name of the Marketing Authorisation holderAlmirall, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Gastro-resistant 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 INNDIMETHYL FUMARATE
    D.3.9.1CAS number 624-49-7
    D.3.9.3Other descriptive nameDIMETHYL FUMARATE
    D.3.9.4EV Substance CodeSUB13608MIG
    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.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 Yes
    D.2.1.1.1Trade name Skilarence
    D.2.1.1.2Name of the Marketing Authorisation holderAlmirall S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Gastro-resistant 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 INNDIMETHYL FUMARATE
    D.3.9.1CAS number 624-49-7
    D.3.9.3Other descriptive nameDIMETHYL FUMARATE
    D.3.9.4EV Substance CodeSUB13608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    Moderate Plaque Psoriasis
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to assess the efficacy of Skilarence® (Dimethyl Fumarate) at Week 24 of treatment
    as measured by static Physician’s Global Assessment score (sPGA) multiplied by percentage Body Surface Area
    (BSA).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to assess impact onÍž
    (1)
    o Dermatology Life Quality Index (DLQI)
    o Psoriasis Area and Severity Index (PASI)
    o Static Physician´s Global Assessment (sPGA)
    o Body Surface Area (BSA)
    o Patient satisfaction with Skilarence® treatment efficacy on psoriasis
    in patients treated with Skilarence® (Dimethyl Fumarate) for 24 weeks and week 72, compared to Baseline.

    (2) To describe the safety profile in moderate patients treated with Skilarence® (Dimethyl Fumarate) over 24 weeks.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A research sub-study is appended to the final version of the main study protocol.
    The aim of this research sub-study is to determine the molecular and cellular phenotype of moderate psoriasis
    patients in response to treatment with Skilarence®.

    The research sub-study is not approved in Denmark.
    E.3Principal inclusion criteria
    In order to participate in this study patients must meet all of the following inclusion criteria:
    • Signed and dated informed consent
    • Males and females ≥ 18 years
    • Diagnosis of plaque psoriasis at least 6 months prior to screening visit
    • BSA ≥ 5% at screening and baseline
    • PASI score between 5 and 10 at screening and baseline
    • Static Physician´s Global Assessment (sPGA) of 3 (moderate) based on a 6 point scale at screening and baseline
    • DLQI ≥ 5 at screening and baseline
    • Wash-out period for topical treatments (≥ 2 weeks) and for phototherapy and other non-biologic systemic therapies
    (≥4weeks) prior to baseline (Visit 2).
    • A candidate to receive systemic treatment for psoriasis based on physician clinical judgement
    • Women of child-bearing potential must have a negative serum pregnancy test at Visit 1 (Screening) and a negative
    urine pregnancy test at Visit 2 (Baseline).
    • Females of child-bearing potential must be willing to use highly effective methods of birth control during the study
    period. Additionally they must agree to have pregnancy tests while on Skilarence®.
    • No previous use of biologic treatments for psoriasis or psoriatic arthropathy.
    E.4Principal exclusion criteria
    In order to participate in the study patients must not meet any of the following exclusion criteria:
    • Females who are pregnant, breast feeding, refuse to use birth control methods or who wish to become pregnant during the study period
    • Diagnosis of other psoriasis clinical subtypes such as guttate, erythrodermic or pustular psoriasis
    • Diagnosis of active psoriatic arthropathy
    • Diagnosis of Fanconi syndrome
    • Baseline white blood cell count <3.0x109/L or lymphocyte count <1.0x109/L
    • Previous malignancies (except for non-melanoma skin cancer)
    • Severe impaired renal function: Severe renal impairment (creatinine clearance < 30 mL/min, estimated GFR using Modification of Diet in Renal Disease (MDRD) formula)
    • Severe hepatic impairment (Child Pugh class C)
    • Abnormal liver enzymes defined by:
    • AST (SGOT), ALT (SGPT) and alkaline phosphatase (ALP) >3x the upper limit of the normal range (ULN) should be excluded. If bilirubin is >2x ULN, then an AST, ALT or ALP of >2x ULN is exclusionary. Elevated gamma-GT (GGT) values exceeding >3x ULN are allowed but these GGT cases will be carefully assessed alongside other clinical and laboratory data by the investigator
    • History of severe gastrointestinal problems
    • History of active infectious disease
    • Known human immunodeficiency virus (HIV)-positive status or suffering from any other immunosuppressive disease
    • Known to be hypersensitive to any of the ingredients of Skilarence®
    • Previously enrolled in any study or participating in any other drug investigational trial within the 30 days (or five half-lives of the investigational product studied, whichever is longer) prior to enrolment
    • History of major psychiatric illness
    • Unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure for this study is defined asÍž
    The mean percentage change from Baseline in the product of sPGA (Static Physician’s Global Assessment) and BSA
    % (Body Surface Area), or sPGA*BSA at Week 24 of treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24 of treatment with Skilarence.
    E.5.2Secondary end point(s)
    (1) Percentage of patients with PASI 75 (≥75% reduction from baseline) at weeks 12, 16 and 24
    (2) Percentage of patients with PASI 50 (≥50% reduction from baseline) at weeks 12, 16, 24 and 72
    (3) Percentage change from baseline in PASI score at weeks 12, 16,24 and 72
    (4) Percentage of patients that achieve PASI score of <1, <3 and <5 at week 24 and week 72
    (5) Absolute PASI scores at weeks 12, 16, 24 and 72
    (6) Percentage change from baseline in BSA at weeks 12, 16, 24 and 72
    (7) Percentage change from baseline in DLQI at weeks 12, 16,24 and 72
    (8) Percentage change from baseline in sPGA*BSA at weeks 12 and 16
    (9) Percentage of patients achieving a score of “clear” or ” almost clear” in sPGA at weeks 12, 16, 24 and 72.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 12, 16,24 and 72.
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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.1.2.1Number of subjects for this age range: 140
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    The patients in the study may be evaluated for further treatment with Skilarence after the study, since this is a product with marketing approval in Norway. Otherwise, alternativ treatment will be evaluated.
    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 Decision2019-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-13
    P. End of Trial
    P.End of Trial StatusOngoing
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