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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41191   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2012-000035-82
    Sponsor's Protocol Code Number:027-008
    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:2012-09-04
    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 number2012-000035-82
    A.3Full title of the trial
    A 2:1 randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of Fumaderm® in young patients aged 10 to 17 years with moderate to severe psoriasis vulgaris (KIFUderm study).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate the efficacy and safety of Fumaderm® in young patients aged 10 to 17 years with moderate to severe psoriasis vulgaris (KIFUderm study).
    A.3.2Name or abbreviated title of the trial where available
    KIFUderm study
    A.4.1Sponsor's protocol code number027-008
    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 SponsorBiogen GmbH
    B.1.3.4CountryGermany
    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 supportBiogen GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSCIderm GmbH
    B.5.2Functional name of contact pointFurther information on the trial
    B.5.3 Address:
    B.5.3.1Street AddressDrehbahn 1-3
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code20354
    B.5.3.4CountryGermany
    B.5.4Telephone number+4940554401115
    B.5.5Fax number+4940554401291
    B.5.6E-mailNorbert.berenzen@SCIderm.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 Fumaderm® Initial
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Idec
    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.3.4Pharmaceutical 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCalcium ethyl fumarate
    D.3.9.1CAS number 62008-22-4
    D.3.9.3Other descriptive nameEthyl hydrogen fumarate Calcium salt (2:1)
    D.3.9.4EV Substance CodeSUB13742MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number67
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMagnesium ethyl fumarate
    D.3.9.1CAS number 83918-60-9
    D.3.9.3Other descriptive nameEthyl hydrogen fumarate Magnesium salt (2:1)
    D.3.9.4EV Substance CodeSUB13743MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZinc ethyl fumarate
    D.3.9.1CAS number 62008-21-3
    D.3.9.3Other descriptive nameEthyl hydrogen fumarate Zinc salt (2:1)
    D.3.9.4EV Substance CodeSUB13744MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 Fumaderm®
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Idec
    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.3.4Pharmaceutical 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCalcium ethyl fumarate
    D.3.9.1CAS number 62008-22-4
    D.3.9.3Other descriptive nameEthyl hydrogen fumarate Calcium salt (2:1)
    D.3.9.4EV Substance CodeSUB13742MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number87
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMagnesium ethyl fumarate
    D.3.9.1CAS number 83918-60-9
    D.3.9.3Other descriptive nameEthyl hydrogen fumarate Magnesium salt (2:1)
    D.3.9.4EV Substance CodeSUB13743MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZinc ethyl fumarate
    D.3.9.1CAS number 8000050-78-4
    D.3.9.3Other descriptive nameEthyl hydrogen fumarate Zinc salt (2:1)
    D.3.9.4EV Substance CodeSUB13744MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 placeboGastro-resistant tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGastro-resistant tablet
    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
    E.1.1.1Medical condition in easily understood language
    Psora
    Schuppenflechte
    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 18.1
    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 primary objective is to evaluate the efficacy and safety of Fumaderm® in patients with moderate to severe psoriasis compared to placebo as assessed by the primary endpoints PASI 75 and/ or PGA 0 or 1 (clear or almost clear) during a 20 week treatment phase.
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the efficacy and tolerability as assessed by:

    • PASI means
    • PASI 50, 75 and 90
    • PGA
    • CDLQI/DLQI
    • NS AE/SAE and Lab values
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed informed consent (by patient and parents)
    • Male and female patients aged 10 to 17 years, using highly effective methods of birth control if they are sexually active or may become sexually active during the study. Highly effective methods of birth control result alone or in combination in a low failure rate (less than 1% per year); e.g. intrauterine devices or hormonal contraceptives, double barrier method.
    • Moderate to severe psoriasis vulgaris according rule of ten (PASI ≥10 or BSA ≥ 10 or CDLQI/DLQI ≥ 10) and the European consensus of treatment goals for moderate to severe psoriasis (i.e. special clinical situations may change mild psoriasis to moderate or to severe including involvement of e.g. visible areas of the head, genital areas or severe nail involvement) and history of psoriasis vulgaris for at least 6 months where previous, externally applied, stand-alone treatments have failed.
    • Need for systemic treatment: moderate to severe forms of psoriasis vulgaris in cases where previous, externally applied, stand-alone treatments have failed.
    • Weight > 30 kg
    E.4Principal exclusion criteria
    • Mild cases of psoriasis vulgaris, e.g. circumscribed plaque psoriasis or chronic stationary plaque psoriasis covering less than 10% of total body surface
    • Psoriasis pustulosa
    • Psoriasis arthritis
    • Values of lymphocytes and leukocytes below the normal range
    • Remaining differential blood count outside the normal range if judged as clinically significant
    • Platelet count outside the normal range if judged as clinically significant
    • Serum creatinine > upper limit of normal (ULN), reduced creatinine-clearance (calculated) (if the calculated creatinine-clearance is reduced with a normal serum creatinine, undertake a 12 h urine collection and re-test the creatinine clearance in this sample)
    • gamma-GT or GOT or GPT > 2-fold ULN
    • Proteinuria (+,++,+++)
    • Systemic therapy with Fumaderm® or Fumaderm® initial prior to the study
    • Systemic biologic therapy with:
    o Etanercept within 3 months prior to study start (defined as date of signed ICF) or during the study
    o Adalimumab, infliximab, or ustekinumab within 6 months prior to study start or during the study.
    o Any prior therapy with efalizumab (Raptiva®)
    • Systemic corticosteroid therapy within 1 month prior to study start or during the study
    • Systemic therapy with methotrexate, ciclosporin or cytostatics within 1 month prior to study start or during the study
    • Phototherapy within 1 month prior to study start or during the study
    • Psoralens within 3 months prior to study start or during the study
    • Systemic therapy with acitretin or other retinoids within 3 months prior to study start or during the study
    • Drugs known to impair renal function 1 month prior to study start or during the study
    • Other Immunosuppressive medication (e.g. azathioprine) within 1 month prior to study start or during the study
    • Topical therapy with Vit. D3 analogues, dithranol, corticosteroids or any other topical treatment of psoriasis within 1 months prior to study start or during the study
    • Significant medical condition in particular gastrointestinal diseases (e.g. ulcus ventriculi and ulcus duodeni) which may affect patient safety and/or drug efficacy and/or study evaluation in the opinion of the investigator, particularly any immunosuppressive state.
    • Significant renal or liver disease
    • Any neoplasm in the patient’s history
    • Acute infections within the past 2 weeks prior to study start
    • Hypersensitivity to Fumaderm®, Fumaderm® initial, any of its ingredients used in Fumaderm® and Fumaderm® initial.
    • Hypersensitivity to Mannitol (replacement of active ingredients in placebo tablets)
    • Hypersensitivity to acrylates, adhesives, plasters, sulfones or desiccants.
    • Pregnant and/or breast-feeding female patients
    • Female patients of childbearing potential who are sexually active or who may become sexually active during the study and who do not agree to use one of the following effective methods of birth control for the duration of the study: Intrauterine devices or hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release), practicing abstinence, double barrier method
    • Male patients who are sexually active or who may become sexually active during the study and who do not agree to use one of the following effective methods of birth control for the duration of the study: double barrier method, which means that the male patients use a condom and the female sexual partners use an effective method of birth control as listed above.
    • Patient or patient’s parents are relatives, partner or employees of any member of the clinical research site personnel
    E.5 End points
    E.5.1Primary end point(s)
    PASI-75 and/or PGA 0 or 1 (clear or almost clear)
    at week 20 Fumaderm® group compared to placebo group
    E.5.1.1Timepoint(s) of evaluation of this end point
    V1 (baseline), V9 (20 weeks)
    E.5.2Secondary end point(s)
    For the treatment period:
    • PASI means
    • PASI 50, 75 and 90
    • PGA
    • CDLQI/DLQI
    • NS AE/SAE and Lab values

    For the follow up period:
    • PASI means
    • PASI 50, 75 and 90
    • PGA
    • CDLQI/DLQI
    • NS AE/SAE and Lab values
    E.5.2.1Timepoint(s) of evaluation of this end point
    For the treatment period:
    • PASI means at V1-V13*/V17**
    • PASI 50, 75 and 90 at V1- V13*/V17**
    • PGA at V1- V13*/V17**
    • CDLQI/DLQI at V1- V13*/V17**
    • NS AE/SAE and Lab values at V1- V13*/V17** will serve as endpoints for clinical safety in this study

    For the follow up period:
    • PASI means at V14-V16*/V18-V20**
    • PASI 50, 75 and 90 at V14-V16*/V18-V20**
    • PGA at V14-V16*/V18-V20**
    • CDLQI/DLQI at V14-V16*/V18-V20**
    • NS AE/SAE and Lab values at V14-V16*/V18-V20**

    * for the Fumaderm®-Fumaderm® group
    ** for the Placebo-Fumaderm® group

    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 Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    After W24 and interim DB-lock, the trial will be open. Pat. from placebo-group will receive Verum
    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 concerned21
    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 Yes
    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
    last visit of last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months10
    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 Yes
    F.1.1Number of subjects for this age range: 133
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 123
    F.1.2Adults (18-64 years) No
    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 state133
    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)
    normal treatment of the condition
    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 Decision2012-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-20
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