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    Summary
    EudraCT Number:2015-003622-13
    Sponsor's Protocol Code Number:1311.28
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-02-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-003622-13
    A.3Full title of the trial
    BI 655066 versus Ustekinumab and placebo comparators in a randomized double blind trIal for Maintenance use in Moderate to severe plaque type psoriasis-2 (UltIMMa-2)
    BI 655066 en comparación con Ustekinumab y placebo en un ensayo aleatorizado, doble cIego, para uso Mantenido en psoriasis en placas de Moderada a grave-2 (UltIMMa-2).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BI 655066 compared to placebo and ustekinumab in patients with moderate to severe chronic plaque psoriasis
    BI 655066 en comparación con placebo y el comparador activo (ustekinumab) en pacientes con psoriasis en placas crónica de moderada a grave.
    A.3.2Name or abbreviated title of the trial where available
    BI 655066 pivotal efficacy trial with placebo and active comparator
    Ensayo pivotal de eficacia de BI 655066 en comparación con placebo y comparador activo
    A.4.1Sponsor's protocol code number1311.28
    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 SponsorBoehringer Ingelheim España, S.A.
    B.1.3.4CountrySpain
    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 supportBoehringer Ingelheim España, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+34 934045100
    B.5.5Fax number+34 934045580
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 nameBI 655066
    D.3.2Product code BI 655066 90 mg/ml
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot available yet
    D.3.9.2Current sponsor codeBI 655066
    D.3.9.3Other descriptive nameBI 655066
    D.3.9.4EV Substance CodeSUB180327
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typehumanized IgG monoclonal antibody
    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 STELARA 90 mg solution for injection in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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.3.1Product nameSTELARA 90 mg solution for injection in pre-filled syringe
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUstekinumab
    D.3.9.1CAS number 815610-63-0
    D.3.9.3Other descriptive nameUSTEKINUMAB
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeAnti-human IL-12/23 monoclonal Antibody
    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 STELARA 45 mg solution for injection in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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.3.1Product nameSTELARA 45 mg solution for injection in pre-filled syringe
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUstekinumab
    D.3.9.1CAS number 815610-63-0
    D.3.9.3Other descriptive nameUSTEKINUMAB
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeAnti-human IL-12/23 monoclonal Antibody
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Psoriasis
    Psoriasis
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    Psoriasis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    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 trial is to assess the efficacy and safety of BI 655066 compared to ustekinumab and placebo in patients with moderate to severe chronic plaque psoriasis.
    El objetivo principal de este estudio es evaluar la eficacia y seguridad de BI 655066 en comparación con ustekinumab y placebo en pacientes con psoriasis en placas crónica de moderada a grave.
    E.2.2Secondary objectives of the trial
    Additionally, this trial will assess PK and the emergence of anti-drug antibodies, as well as the influence of study treatment on disease specific biomarkers, psoriatic arthritis, and metabolic risk factors.
    Además, en este estudio se evaluarán la PK y la aparición de anticuerpos antifármaco (ADA) así como de qué manera el uso de BI 655066 puede influir en los niveles de expresión génica y proteica y en los marcadores de proteínas específicos de la enfermedad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female patients with age >= 18 years at screening,

    Women of childbearing potential must be ready and able to use highly effective methods of birth control,

    Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug.

    Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization):
    a. Have an involved body surface area (BSA) >= 10% and
    b. Have a Psoriasis Area and Severity Index (PASI) score >= 12 and
    c. Have a static Physician Global Assessment (sPGA) score of >= 3.

    Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator

    Must be a candidate for treatment with Stelara® (ustekinumab) according to local label.
    Pacientes varones o mujeres de edad ? 18 años en el momento de la inclusión

    Las mujeres potencialmente fértiles* deben querer y poder utilizar métodos anticonceptivos altamente eficaces

    Tener un diagnóstico de psoriasis en placas crónica (con o sin artritis psoriásica) durante al menos 6 meses antes de la primera administración del fármaco del estudio.

    Tener psoriasis en placas crónica de moderada a grave con o sin artritis psoriásica en los periodos de selección y basal (aleatorización):
    a. tener una BSA afectada ? 10 % y,
    b. tener una puntuación PASI ? 12 y,
    c. tener una puntuación sPGA ? 3.

    Debe ser candidato para el tratamiento sistémico o fototerapia para el tratamiento de la psoriasis, a juicio del investigador.

    Debe ser candidato para el tratamiento con Stelara® (ustekinumab) según la ficha técnica local.
    E.4Principal exclusion criteria
    Patients with:
    a. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular),
    b. current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium),
    c. active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to investigators judgment,

    Previous exposure to BI 655066,
    Previous exposure to ustekinumab (Stelara®),

    Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study (participation in observational studies is permitted),

    Use of any restricted medication , or any drug considered likely to interfere with the safe conduct of the study,

    Major surgery performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g. hip replacement, aneurysm removal, stomach ligation),

    Known chronic or relevant acute infections including active tuberculosis, HIV or viral hepatitis,

    Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix,

    Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and ECG), or laboratory value at the screening visit outside the reference range that is in the opinion of the investigator, is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data,

    History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients,

    Women who is pregnant, nursing, or who plans to become pregnant while in the trial,
    Pacientes con
    a. formas de psoriasis no en placas (incluida en gotas, eritrodérmica o pustulosa).
    b. Psoriasis actual inducida por fármacos (incluida una exacerbación de la psoriasis de los betabloqueantes, antagonistas del calcio o litio).
    c. Enfermedades inflamatorias activas en curso distintas de la psoriasis y la artritis psoriásica que podrían confundir las evaluaciones del estudio según el criterio del investigador.

    Exposición previa a BI 655066.
    Exposición previa a ustekinumab (Stelara®).

    Pacientes incluidos actualmente en otro estudio de investigación o que hayan transcurrido menos de 30 días (desde la selección) desde que concluyó otro estudio de investigación (se permite la participación en estudios observacionales).

    Uso de cualquier medicación restringida o de algún fármaco que se considere probable que interfiera con la realización seguro del estudio.

    Cirugía mayor realizada en las 12 semanas anteriores a la aleatorización o programada en los 12 meses después de la selección (p. ej., artroplastia de cadera, eliminación de aneurisma, ligadura de estómago).

    Infecciones crónicas o infecciones agudas relevantes incluida la tuberculosis activa, el HIV o la hepatitis vírica

    Cualquier neoplasia maligna documentada o sospecha de la misma o antecedentes de neoplasia maligna en los 5 años anteriores a la selección, salvo el carcinoma espinocelular o basocelular tratado o el carcinoma in situ del cuello uterino.

    Prueba de una afección actual o previa, enfermedad (incluidos el abuso del alcohol y las drogas) aparte de psoriasis, intervención quirúrgica (por ejemplo, trasplante de órganos), hallazgo de una exploración clínica (incluidas la constantes vitales y el ECG), o valor analítico en la visita de selección fuera del intervalo de referencia que, en opinión del investigador, sea clínicamente significativo y haría que el participante en el estudio fuera poco fiable a la hora de cumplir el protocolo o realizar el estudio, pondría en peligro la seguridad del paciente, o pondría en peligro la calidad de los datos.

    Antecedentes de alergia/hipersensibilidad a un agente biológico de administración sistémica o a sus excipientes. Mujeres embarazadas, en periodo de lactancia o que prevean quedarse embarazadas durante el periodo del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    1: Achievement of >= 90% reduction from baseline PASI score (PASI 90) at Week 16

    2: Achievement of a sPGA score of clear or almost clear at Week 16
    1: Alcanzar una reducción ? 90 % con respecto a la puntuación PASI inicial (PASI 90) en la semana 16.

    2: Alcanzar una puntuación sPGA de remisión total o casi total en la semana 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: week 16 from first trial medication

    2: week 16 from first trial medication
    1: semana 16 tras la primera medicación

    2: semana 16 tras la primera medicación
    E.5.2Secondary end point(s)
    1: Achievement of >= 75% reduction from baseline PASI score (PASI 75) at Week 12

    2: Achievement of a sPGA score of clear or almost clear at Week 12

    3: Achievement of 100% reduction from baseline PASI score (PASI 100) at Week 16

    4: Achievement of >= 90% reduction from baseline PASI score (PASI 90) at Week 52

    5: Achievement of 100% reduction from baseline PASI score (PASI 100) at Week 52

    6: Change from baseline in psoriasis symptoms evaluated using the total score on the PSS at week 16

    7: Achievement of a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16

    8: Achievement of total score on the PSS of 0 at week 16
    1- Alcanzar una reducción ? 75 % con respecto a la puntuación PASI inicial (PASI 75) en la semana 12.
    2- Alcanzar una puntuación sPGA de remisión total o casi total en la semana 12.
    3- Alcanzar una reducción del 100 % con respecto a la puntuación PASI inicial (PASI 100) en la semana 16.
    4- Alcanzar una reducción ? 90 % con respecto a la puntuación PASI inicial (PASI 90) en la semana 52.
    5- Alcanzar una reducción del 100 % con respecto a la puntuación PASI inicial (PASI 100) en la semana 52.
    6- Cambio con respecto a la situación basal en los síntomas de psoriasis, evaluados utilizando la puntuación total en la Escala de síntomas de la psoriasis (PSS) en la semana 16.
    7- Alcanzar una puntuación en el Índice de calidad de vida en dermatología (DLQI) de 0 o 1 en la semana 16.
    8- Alcanzar una puntuación total en la PSS de 0 en la semana 16.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: week 12

    2: week 12

    3: week 16

    4: week 52

    5: week 52

    6: week 16

    7: week 16

    8: week 16
    1: semana 12

    2: semana 12

    3: semana 16

    4: semana 52

    5: semana 52
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Belgium
    Canada
    France
    Germany
    Italy
    Mexico
    Netherlands
    Poland
    Portugal
    Spain
    United States
    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
    Última visita del último paciente
    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 months6
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days20
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 425
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 500
    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)
    There will be an open-label extension study for those who qualify, otherwise patients will be treated according to clinical practice.
    Habrá un estudio de extensión abierto para aquellos que califican, de lo contrario los pacientes se tratarán según la práctica clínica.
    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 Decision2016-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-04
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