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    Summary
    EudraCT Number:2012-005685-35
    Sponsor's Protocol Code Number:FP187-301
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-07-26
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-005685-35
    A.3Full title of the trial
    A randomised, double blind, double dummy, active comparator and placebo controlled confirmative non-inferiority trial of FP187 compared to Fumaderm in moderate to severe plaque psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare the efficacy of a new developed product, FP187, to a marketed product, to each other but also to placebo, in patients with moderate to severe plaque psoriasis. The patients will be assigned to one of the three treatment arms by chance,and neither the investigator nor the patient will know the assigned group.
    A.4.1Sponsor's protocol code numberFP187-301
    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 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 supportForward Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationForward Pharma GmbH
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressDeutscher Platz 5A
    B.5.3.2Town/ cityLeipzig
    B.5.3.3Post code04103
    B.5.3.4CountryGermany
    B.5.4Telephone number49341993 9988
    B.5.5Fax number49341998 5658
    B.5.6E-mailFP187.trial@forward-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 nameFP187
    D.3.2Product code FP187
    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.3.9.2Current sponsor codeFP187
    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 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) 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 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 nameFumaric acid monoethyl ester, calcium salt
    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 INNZINC ETHYL FUMARATE
    D.3.9.1CAS number 62008-21-3
    D.3.9.3Other descriptive nameFumaric acid monoethyl ester, zinc salt
    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.3.8 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 nameFumaric acid monoethyl ester, magnesium salt
    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.3.11 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: 3
    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 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 nameFumaric acid monoethyl ester, calcium salt
    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 INNZINC ETHYL FUMARATE
    D.3.9.1CAS number 62008-21-3
    D.3.9.3Other descriptive nameFumaric acid monoethyl ester, zinc salt
    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.3.8 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 nameFumaric acid monoethyl ester, magnesium salt
    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.3.11 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 placeboCoated 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 placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated 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
    Moderate to severe plaque psoriasis
    E.1.1.1Medical condition in easily understood language
    Moderate to severe plaque 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 10071117
    E.1.2Term Plaque psoriasis
    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 show non-inferiority of FP187 to Fumaderm® after 20 weeks of treatment with a 500 mg daily dose of FP187 (250 mg BID) against a 720 mg daily dose of Fumaderm® (240 mg TID) on two co-primary endpoints:
    - The proportion of patients achieving PASI75 with the predefined non-inferiority margin of 15 per cent points difference in PASI75.
    - The proportion of patients achieving a “clear” or “almost clear” score, or a 2 point improvement from baseline on sPGA.
    Both endpoints will be assessed after 20 weeks of treatment, and the non-inferiority margin for the proportions of patients achieving each endpoint will be 15 percentage points.
    E.2.2Secondary objectives of the trial
    • Compare the efficacy of 500mg FP187 (250mg BID) to 720mg Fumaderm (240mg TID) & placebo at weeks 4, 8, 12, 16 & 20 on:
    - proportion of patients achieving sPGA of ‘clear’ or ‘almost clear’, or at least a 2 point improvement from baseline
    -proportion of patients achieving PASI75
    -proportion of patients achieving PASI50 & PASI90
    -the absolute & relative change in PASI and in BSA
    -proportion of responders on the combined PASI50 & Dermatology Life Quality Index (DLQI)≤5
    -the patient achieving DLQI ≤5
    -the patient rated DLQI
    -pruritus measured on a VAS scale
    -at weeks 12 & 20 on Patient Benefit Index
    -at week 20 on improvement on nail disease using the NAPSI score
    •Assess pain relief in patients with psoriasis arthritis
    •Investigate lab safety on haematology and renal function, liver enzymes & standard biochemistry in the 3 treatment arms
    •Assess safety & tolerability of FP187 during the full duration of the trial based on AE and SAE reporting and supportive questionnaires
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Patients of either sex at least 18 years of age
     Patients with a clinical diagnosis of stable moderate to severe plaque psoriasis (PASI value above 10) for at least 6 months prior to trial start will be eligible for randomization for the trial.
     Patients with a clinical diagnosis of plaque psoriasis defined as skin areas with erythema, induration and scaling, with an affected body surface area (BSA)>10% and in total to be scoring > 10 on the PASI scale and on the sPGA score at least as moderate (≥3 at the 6-point scale), defined as:
    -Systemic treatment naive patients who cannot be controlled in their disease symptoms with a topical treatment and are candidates for systemic treatment; or
    - Patients who have failed under treatment with other first or second line systemic treatments.
     Signed and dated informed consent,
     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:
    – Systemic contraceptive (oral, implant, injection),
    – Intrauterine device (IUD) inserted for at least one month prior to trial entrance
     Willingness and ability to comply with the trial procedures.
     Besides psoriasis, patient is 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 160/95] pulse rate [between 50 and 100]), electrocardiogram (ECG), and clinical laboratory parameters (haematology, 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.
     Patients have to have a DLQI>10
    E.4Principal exclusion criteria
     Female patients who are pregnant or breast-feeding or planning to become pregnant during the entire trial period as well as male patients planning pregnancy with their partner during the entire trial period or practice unprotected sexual relationship during the entire trial period.
     Male patients planning pregnancy with their partner during the entire trial period, or practicing unprotected sexual relationship during the entire trial period.
     Known allergy to any of the constituents of the products being tested,
     Pustular forms of psoriasis, erythrodermic or guttate psoriasis,
     Known immunosuppressive diseases (e.g., AIDS/HIV),
     Presence of another serious or progressive disease including skin malignancies, which, according to the Investigator may interfere with treatment outcome,
     Active skin disease such as atopic dermatitis, rosacea, lupus erythematous, 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 Visit 3
     Use of systemic anti-psoriatic treatment preceding Visit 3:
    – Methotrexate, cyclosporine, steroids or PUVA treatment within 4 weeks,
    – Biological treatment (efalizumab, adalimumab, infliximab, etanercept) within 12 weeks, or Stelara within 20 weeks
    – Acitretin within 6 months,
    -– Not named drugs should have a wash-out of 5 times their half-life
     Treatment with Fumaderm® or other DMF containing products during the past 12 weeks prior to Visit 3,
     Has within the past 4 weeks prior to Visit 3 been treated with drugs influencing the course of the psoriasis such as antimalarial drugs, or lithium,
     Treatment with retinoids, other immunosuppressive treatment, cytostatics or drugs with known harmful effects on the kidneys within the last 3 month, also if currently kidney functions are normal.
     Has on-going stomach or intestinal problems (e.g. gastritis or peptic ulcer),
     Has liver enzyme results (AST, ALT,) > 2 x upper normal limit (ULN) or gamma-GT results > 2.5 x ULN
     Has an estimated Creatinine Clearance (Cockcroft-Gault): < 60 ml/min,
     Has leucopenia (leukocyte count < 3.5x109/l) or eosinophilia (count > 750/μl) or lymphocytopenia (count < 1.02 x109/l),
     Has protein in the urine stick test at Visit 1 and at Visit 2, and confirmed in a subsequent complete urine analysis
     Participation in another clinical trial during the last two months preceding Visit 3 or participation in a trial with treatment with biologicals within 6 months prior to Visit 3,
     Patients who are involved in the organisation of the clinical investigation or are in any way dependent on the Investigator or sponsor
     Patients in whom Fumaderm® is contraindicated.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients achieving PASI75 (from baseline) and the responder rate of sPGA as co-primary endpoint (achieving a score of “clear” or “almost clear”, or a 2 point improvement on a 6-point scale) both measured after 20 weeks of treatment for Placebo, FP187 and Fumaderm® patients.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint measured after 20 weeks of treatment for Placebo, FP187 and Fumaderm® patients.
    E.5.2Secondary end point(s)
    -Proportion of patients with “clear” or “almost clear”, or a 2 point improvement on the 6-point sPGA scale at weeks 4, 8, 12, 16 and 20;
    -The proportion of patients achieving PASI75 at weeks 4, 8, 12, 16 and 20;
    -The proportion of patients achieving PASI50 and PASI90 at weeks 4, 8, 12, 16 and 20;
    -The absolute and relative reduction in PASI at weeks 4, 8, 12, 16 and 20;
    -The absolute and relative reduction in BSA at weeks 4, 8, 12, 16 and 20
    -The proportion of responders on the combined PASI50 AND DLQI≤5 at weeks 4, 8, 12, 16 and 20;
    -The proportion of patients achieving DLQI≤5 at weeks 4, 8, 12, 16 and 20 on the patient rated DLQI;
    -The absolute and relative change from baseline on DLQI at weeks 4, 8, 12, 16 and 20
    -The change from baseline to weeks 12 and 20 in PBI;
    -The change from baseline to weeks 4, 8, 12, 16 and 20 on pruritus measured on a VAS scale;
    -The change from baseline of pain reported in patients with psoriasis arthritis measured on a VAS scale
    -The change from baseline to week 20 in nail disease using the NAPSI score.
    Safety endpoints:
    -The incidence of change in laboratory data, in particular haematology (WBC, eosinophils, lymphocytes), biochemistry (liver enzymes, renal parameters including creatinine, calculated creatinine clearance and proteinuria);
    -The incidence and severity of flushing reported
    -The incidence and severity of diarrhea, abdominal pain, nausea and vomiting reported
    -The drop-out rate due to drug related AE’s
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints measured at various timepoints throughout the duration of the trial, see E.5.2. above.
    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 Yes
    E.8.1.7.1Other trial design description
    Adaptive group sequential design with one interim analysis after 40% sample have >12 weeks treatment
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Canada
    France
    Germany
    Russian Federation
    Ukraine
    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
    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 months3
    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 months3
    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: 744
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 56
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 800
    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)
    It is planned to offer patients continued treatement with FP187 under a separate open protocol
    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 Decision2013-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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