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    Summary
    EudraCT Number:2010-020168-39
    Sponsor's Protocol Code Number:FP187-201
    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:2010-06-09
    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 number2010-020168-39
    A.3Full title of the trial
    A randomised, double blind, placebo controlled efficacy and safety trial of different doses/dose regimens of FP187 compared to placebo in moderate to severe plaque psoriasis.
    A.4.1Sponsor's protocol code numberFP187-201
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorForward Pharma 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameFP 187
    D.3.2Product code FP 187
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.2Current sponsor codeFP 187
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typedimethyl fumarate
    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
    stable moderate to severe plaque psoriasis (PASI above 10) for at least 6 months prior to study
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10050576
    E.1.2Term Psoriasis vulgaris
    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 two different BID doses and one TID dose of FP187 to placebo after 20 weeks of treatment on proportion of patients achieving PASI 75.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare and describe the efficacy and safety of different dose levels/regimens of FP187 compared to placebo with regards to:
    At V6 (week 4), V7 (w 8), V8 (w12), V9 (w16), V12 (w26), V13 (w32), V14 (w40) and V15 (w48):
    – Proportion of responders achieving PASI 75,
    At V6 (w4), V7 (w8), V8 (w12), V9 (w16), V10 (w20), V12 (w26), V13 (w32), V14 (w 40) and V15 (w48):
    – Proportion of responders achieving PASI 50 and PASI 90
    – Proportion of responders on the static Physician's Global Assessment score (sPGA) and the actual scores
    – Patient global assessment score,
    – Patient QoL score (DLQI),
    – Patient assessed pruritus,
    – Exploratory analysis of a possible effect of FP187 on cholesterol and triglycerides
    – Overall safety and tolerability
    – To perform a full exploratory analysis as above on the data generated in the subset of patients who has continued with the extended treatment for up to 48 w. and the post treatment follow up.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be entered into this trial only if they meet all of the following criteria:
    • Patients of either sex at least 18 years of age
    • A clinical diagnosis of plaque psoriasis defined as skin areas with erythema, induration and scaling, with a body surface area score of no less than 10% and in total to be scoring at least 10 on the PASI scale.
    • The psoriasis disease have been stable for at least 6 months at randomisation
    • Signed and dated informed consent,
    • Sexually active females of childbearing potential must be either surgically sterile (hysterectomy or tubal ligation) or use a highly effective (failure rate <1%) medically accepted contraceptive method during the trial as well as one month after trial is finished such as:
    o Systemic contraceptive (oral, implant, injection),
    o Intrauterine device (IUD) inserted for at least one month prior to study entrance.
    • Willingness and ability to comply with the trial procedures.
    • Patient is beside the psoriasis disease in good general health in the opinion of the Investigator, as determined by medical history, physical examination, vital signs (systolic and diastolic blood pressure [upper limit 145/90] pulse rate [between 50 and 100]), electrocardiogram (ECG), and clinical laboratory parameters (hematology, biochemistry and urinalysis). Minor deviations of laboratory values from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.
    E.4Principal exclusion criteria
    Patients will not be enrolled if they meet any of the following criteria:
    • Female patients who are pregnant or breast-feeding or planning to become pregnant up to 7 months from treatment start as well as male patients planning pregnancy with their partner up to 7 months from treatment start or practise unprotected sexual relationship up to 7 months from treatment start.
    • Known allergy to any of the constituents of the product being tested,
    • Pustular forms of psoriasis, erythrodermic or guttate psoriasis
    • Known immunosuppressive diseases (e.g., AIDS/HIV)
    • Presence of another serious or progressive disease which, according to the Investigator may interfere with treatment outcome,
    • Active skin disease such as atopic dermatitis, rosacea, lupus erythematosus, or other inflammatory or infectious skin disease which, according to the Investigator may interfere with treatment outcome,
    • Use of topical medical treatment or UVB treatment during the 2 weeks preceding the baseline visit (Day -5),
    • Use of systemic anti-psoriatic treatment preceding the baseline visit (Day -5):
    .1 Methotrexate, cyclosporine, steroids or PUVA treatment within 4 weeks,
    .2 Biological treatment (efalizumab, adalimumab, infliximab, etanercept) within 12 weeks
    .3 Acitretin within 6 months
    • Treatment with Fumaderm® or other DMF containing products during past 24 weeks prior to baseline visit (Day -5)
    • Discontinuation of previous treatment with Fumaderm® or other DMF containing products due to lack of efficacy or side effects
    • Has within the past 4 weeks prior to baseline visit been treated with drugs influencing the course of the psoriasis such as antimalarial drugs or lithium
    • Has a relevant clinical history of stomach or intestinal problems (eg gastritis or peptic ulcer within the last 10 years )
    • Has liver enzyme measures (AST, ALT,gamma-GT) higher than 2 x UNL
    • Has an estimated Creatinine Clearance (Cockcroft-Gault): < 60 ml/min
    • Has leucopenia (leukocyte count < 3500/mm3) or eosinophilia (count > 750/µl) or lymphopenia (count < 1.02/nl).
    • Has protein in the urine test at screening or baseline visit
    • Participation in another clinical trial during the last month preceding the baseline visit (Day -5) or participation in a trial with treatment of biologicals within 6 months prior to baseline visit.
    • Patients who are involved in the organization of the clinical investigation or are in any way dependant on the investigator or sponsor
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of responders, defined as patients achieving PASI 75 (reduction in PASI of at least 75% from baseline) at Visit 10 (Week 20).
    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) 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.8.3 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 concerned18
    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 Information not present in EudraCT
    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
    trial will be closed when all patients have completed Visit 11 or Visit 16 respectively for all patients willing to participate in the extension period and all data queries have been resolved.
    section 9.10 in the protocol defines the Premature Termination of the Trial
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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 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 state180
    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 Decision2010-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-09
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