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    Summary
    EudraCT Number:2015-002653-35
    Sponsor's Protocol Code Number:R668-AD-1424
    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:2017-02-28
    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 number2015-002653-35
    A.3Full title of the trial
    A phase 3 study investigating the efficacy, safety, and tolerability of Dupilumab administered to adult patients with severe atopic dermatitis who are not adequately controlled with or are intolerant to oral cyclosporine A, or when this treatment is not medically advisable
    Estudio de fase III para investigar la eficacia, la seguridad y la tolerabilidad de Dupilumab administrado a pacientes adultos con dermatitis atópica grave que no estén adecuadamente controlados con o no toleren bien la Ciclosporina A por vía oral, o cuando este tratamiento no sea aconsejable desde el punto de vista médico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the efficacy and safety of Dupilumab in patients with severe atopic dermatitis (AD) that are not controlled with oral cyclosporine A (CSA) or for those who cannot take oral CSA because it is not medically advisable
    Estudio para evaluar la eficacia y la seguridad de Dupilumab en pacientes con dermatitis atópica grave (DA) que no estén controlados con Ciclosporina A por vía oral (CSA), o para aquellos que no puedan tomar CSA por vía oral porque no sea aconsejable desde el punto de vista médico.
    A.4.1Sponsor's protocol code numberR668-AD-1424
    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 SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post codeNY 10591
    B.5.3.4CountryUnited States
    B.5.4Telephone number0034911917183
    B.5.6E-mailclinicaltrials@regeneron.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 nameDupilumab
    D.3.2Product code REGN668/SAR231893
    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 INNDupilumab
    D.3.9.1CAS number 1190264-60-8
    D.3.9.2Current sponsor codeREGN668/SAR231893
    D.3.9.3Other descriptive nameDUPILUMAB
    D.3.9.4EV Substance CodeSUB130625
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 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
    Atopic dermatitis
    Dermatitis atópica
    E.1.1.1Medical condition in easily understood language
    Atopic dermatitis / Eczema
    Dermatitis atópica / Eczema
    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 19.1
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    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 evaluate the efficacy of 2 dose regimens of dupilumab compared to placebo, administered with concomitant topical corticosteroids (TCS), in adult patients with severe AD who are not adequately controlled with, or are intolerant to, oral CSA, or when this treatment is currently not medically advisable.
    Evaluar la eficacia de 2 pautas posológicas de dupilumab en comparación con placebo, administrado con corticoesteroides tópicos (CeT) concomitantes en pacientes adultos con DA grave que no están adecuadamente controlados con o que no toleran la CsA por vía oral, o cuando este tratamiento no aconsejable desde el punto de vista médico en ese momento.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of 2 dose regimens of dupilumab compared to placebo, administered with concomitant TCS, in adult patients with severe AD who are not adequately controlled with, or are intolerant to, oral CSA, or when this treatment is currently not medically advisable.
    Evaluar la seguridad y la tolerabilidad de 2 pautas posológicas de dupilumab en comparación con placebo, administrado de forma concomitante con CeT en pacientes adultos con DA grave que no están adecuadamente controlados con la CsA, o que no toleran la CsA, por vía oral, o cuando este tratamiento no es aconsejable desde el punto de vista médico en ese momento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, 18 years or older
    2. Severe, Chronic AD, (according to American Academy of Dermatology Consensus Criteria [Eichenfield 2014])
    3. EASI score ?20 at the screening and baseline visits
    4. IGA score ?3 (on the 0 to 4 IGA scale) at the screening and baseline visits
    5. ?10% body surface area (BSA) of AD involvement at the screening and baseline visits
    6. Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with TCS
    7. Have applied a stable dose of topical emollient (moisturizer) twice daily for at least the 7 consecutive days immediately before the baseline visit
    8. Documented history by a physician of either:
    A. No prior CSA exposure and not currently a candidate for CSA treatment due to:
    ? medical contraindications (eg, uncontrolled hypertension on medication), or
    ? use of prohibited concomitant medications (eg, statins, digoxin, macrolide
    ? antibiotics, barbiturates, anti-seizure, nonsteroidal anti-inflammatory drugs,
    ? diuretics, angiotensin-converting-enzyme inhibitors, St John?s Wort, etc), or
    ? increased susceptibility to CSA-induced renal damage (elevated creatinine) and
    ? liver damage (elevated function tests), or
    ? increased risk of serious infections, or
    ? hypersensitivity to CSA active substance or excipients,
    OR
    B. Previously exposed to CSA, and CSA treatment should not be continued or restarted due to:
    ? intolerance and/or unacceptable toxicity (eg, elevated creatinine, elevated liver function tests, uncontrolled hypertension, paraesthesia, headache, nausea, hypertrichosis, etc), or
    ? inadequate response to CSA (defined as flare of AD on CSA tapering after a maximum of 6 weeks of high dose [5 mg/kg/day] to maintenance dose [2 to 3 mg/kg/day] or a flare after a minimum of 3 months on maintenance dose). Flare is defined as increase in signs and/or symptoms leading to escalation of therapy, which can be an increase in dose, a switch to a higher-potency class of TCS, or the start of another systemic non-steroidal immunosuppressive drug. Or
    ? requirement for CSA at doses >5 mg/kg/day, or duration beyond those specified in the prescribing information (>1 year).
    1. Varón o mujer de edad igual o superior a 18 años.
    2. DA crónica grave, según los criterios de consenso de la Academia Estadounidense de Dermatología (American Academy of Dermatology[Eichenfield 2014]).
    3. Puntuación del índice de gravedad y área del eccema (EASI) ?20 en las visitas de selección e inicial.
    4. Puntuación EGI ?3 (en la escala EGI de 0 a 4) en las visitas de selección e inicial.
    5. Afectación de DA en las visitas de selección e inicial ?10% del área de superficie corporal (ASC).
    6. Antecedentes recientes documentados (en los 6 meses anteriores a la visita de selección) de respuesta inadecuada al tratamiento con CeT.
    7. Haber aplicado una dosis estable de un emoliente (hidratante) tópico 2 veces al día como mínimo 7 días consecutivos inmediatamente antes de la visita inicial.
    8. Antecedentes documentados por un médico de:
    A. No haber estado expuesto previamente a CsA y no ser en ese momento candidato al tratamiento con CsA debido a:
    - Contraindicaciones médicas (p. ej., hipertensión no controlada con medicación), o
    - uso de medicaciones concomitantes prohibidas (p. ej., estatinas, digoxina, antibióticos macrólidos, barbitúricos, anticonvulsivantes, antiinflamatorios no esteroideos, diuréticos, inhibidores de la enzima convertidora de la angiotensina, hipérico, etc.), o
    - aumento de la sensibilidad a lesión renal inducida por CsA (creatinina elevada) y a lesión hepática (pruebas de función hepática elevadas), o
    - riesgo incrementado de infecciones graves, o
    - hipersensibilidad al principio activo de CsA o a alguno de sus excipientes, o
    O
    B. Haber estado expuesto previamente a CsA, y el tratamiento con CsA no debería continuarse ni volverse a iniciar debido a:
    - intolerancia y/o toxicidad inaceptable (p. ej., creatinina elevada, pruebas de función hepática elevadas, hipertensión no controlada, parestesias, cefalea, náuseas, hipertricosis, etc.), o
    - respuesta inadecuada a la CsA (definida como una reagudización de la DA al disminuir progresivamente la CsA tras un máximo de 6 semanas de dosis alta [5 mg/kg/día] a la dosis de mantenimiento [2 a 3 mg/kg/día] o una reagudización tras un mínimo de 3 meses con la dosis de mantenimiento). Una reagudización se define como un aumento de los signos y/o síntomas que origina un aumento gradual del tratamiento, que puede consistir en un aumento de la dosis, un cambio a una clase más potente de CeT, o el inicio de otro fármaco inmunosupresor no esteroideo sistémico. O
    - necesidad de CsA en dosis >5 mg/kg/día o duración superior a la especificada en la información de la ficha técnica (>1 año).
    E.4Principal exclusion criteria
    1. Participation in a prior dupilumab clinical study
    2. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the screening visit
    3. Hypersensitivity and/or intolerance to corticosteroids or to any other ingredients contained in the TCS product used in the study
    4. Systemic CSA, systemic corticosteroids, or phototherapy within 4 weeks prior to screening, and azathioprine (AZA), methotrexate (MTX), mycophenolate mofetil (MMF), or Janus kinase (JAK) inhibitors within 8 weeks prior to screening
    5. Treatment with TCI within 1 week before the screening visit
    6. Treatment with biologics as follows:
    ? Any cell-depleting agents including but not limited to rituximab: within 6 months before the screening visit, or until lymphocyte count returns to normal, whichever is longer
    ? Other biologics: within 5 half-lives (if known) or 16 weeks prior to the screening visit, whichever is longer
    7. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit
    8. Treatment with a live (attenuated) vaccine within 12 weeks before the screening
    9. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the screening
    or superficial skin infections within 1 week before the screening visit. NOTE: patients may be rescreened no sooner than 2 weeks after infection resolves.
    10. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis [TB], histoplasmosis, Listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per investigator judgment
    11. Presence of any 1 of the following TB criteria:
    a. A positive tuberculin skin test at the screening visit
    b. A positive blood QuantiFERON®-TB or T-Spot test at the screening visit
    c. Chest x-ray (posterior-anterior and lateral views) at screening or within 3 months before the screening visit (radiology report must be available) with results consistent with prior TB infection (including but not limited to apical scarring, apical fibrosis, or multiple calcified granuloma). This does not include non-caseating granulomata.
    NOTE: Any of these 3 TB tests will be performed on a country-by-country basis according to local guidelines only if required by regulatory authorities or ethics boards.
    12. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
    13. Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBc Ab), or hepatitis C antibody (HCV Ab) at the screening visit
    1. Participación en un estudio clínico de dupilumab anterior
    2. Tratamiento con un fármaco en investigación en las 8 semanas o 5 semividas (si se conoce), lo que sea más prolongado, antes de la selección
    3. Hipersensibilidad y/o intolerancia a los corticoesteroides o a cualquiera de los demás ingredientes que contiene el producto de CeT usado en el estudio
    4. Tratamiento sistémico con CsA, corticoesteroides sistémicos o fototerapia en las 4 semanas anteriores a la selección, y azatioprina (AZA), metotrexato (MTX), micofenolato mofetilo (MMF), o inhibidores de la janocinasa (JAK) en el plazo de las 8 semanas anteriores a la selección
    5. Tratamiento con un ICT en la semana anterior a la visita de selección
    6. Tratamiento con los agentes biológicos que siguen:
    ? Cualquier fármaco que produzca reducción celular incluido, entre otros, rituximab: en los 6 meses anteriores a la visita de selección, o hasta que el recuento de linfocitos vuelva a la normalidad, lo que sea más prolongado
    ? Otros fármacos biológicos: en el plazo de 5 semividas (si se conoce) o 16 semanas previas a la visita de selección, lo que sea más prolongado
    7. Uso regular (más de 2 visitas por semana) de una cabina/centro de bronceado en las 4 semanas previas a la visita de selección
    8. Tratamiento con una vacuna de microorganismos vivos (atenuados) en las 12 semanas antes de la visita de selección
    9. Infección aguda o crónica activa que requiera tratamiento con antibióticos, antivíricos, antiparasitarios, antiprotozoarios, o antifúngicos sistémicos en las 2 semanas anteriores a la visita de selección, o infecciones cutáneas superficiales en el plazo de 1 semana antes de la visita de selección
    NOTA: los pacientes pueden repetir la selección como muy temprano 2 semanas después de que se resuelva la infección
    10. Antecedentes conocidos o sospecha de inmunosupresión, incluidos antecedentes de infecciones oportunistas invasivas (p. ej., tuberculosis [TB], histoplasmosis, listeriosis, coccidioidomicosis, neumocistosis, aspergilosis) a pesar de la resolución de la infección; o infecciones recurrentes o inusualmente frecuentes, o infecciones prolongadas, según el juicio del investigador
    11. Presencia de cualquiera de los criterios de TB que siguen:
    a. Una prueba cutánea de la tuberculina positiva en la visita de selección
    b. Una prueba en sangre de QuantiFERON®-TB o prueba T-Spot positivas en la visita de selección
    c. Radiografía de tórax (proyección posteroanterior y lateral) en la selección o en los 3 meses anteriores a la visita de selección (el informe de radiología debe estar disponible) con resultados coherentes con una infección de TB previa (incluidos, entre otros, cicatrización apical, fibrosis apical o granulomas calcificados múltiples). Esto no incluye granulomas no caseificantes.
    NOTA: se llevará a cabo una de estas 3 pruebas de la TB dependiendo del país y según las directrices locales solo si así lo exigen las autoridades reguladoras o comités de ética.
    12. Antecedentes de infección por el virus de la inmunodeficiencia humana (VIH) o serología positiva para el VIH en la selección
    13. Antígeno de superficie de la hepatitis B (HBsAg), anticuerpo del núcleo de la hepatitis B (Anti-HBc) o anticuerpos de la hepatitis C (anti-VHC) positivos en la visita de selección.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in the study is the proportion of patients with EASI 75 (?75% improvement from baseline) at week 16
    El criterio de valoración principal del estudio es la proporción de pacientes con EASI de 75 (mejoría ?75% desde el valor inicial) en la semana 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 16.
    En la semana 16
    E.5.2Secondary end point(s)
    The secondary endpoints are:

    Efficacy
    - Proportion of patients with EASI 75 (?75% improvement from baseline) at week 16 for patients with prior CSA use
    - Proportion of patients with IGA 0 or 1 (on the 0 to 4 IGA scale) and a reduction from baseline of ?2 points at week 16
    - Percent change from baseline to week 16 in the pruritus NRS
    - Percent change from baseline to week 16 in the SCORAD
    - Change in Quality of Life Measures

    Safety and Tolerability
    - Incidence of treatment-emergent serious adverse events (TESAEs) from baseline through the on-treatment period
    - Overall incidence of TEAEs from baseline through the on-treatment period
    Los criterios de valoración secundarios son:

    Eficacia
    ? Proporción de pacientes con un EASI 75 (mejoría ?75% desde el inicio) en la semana 16 para los pacientes con uso previo de CsA
    ? Proporción de pacientes con una EGI de 0 o 1 (en una escala de 5 puntos) y una reducción ?2 puntos desde el inicio en la semana 16
    ? Cambio porcentual en la escala EVN del prurito desde el inicio hasta la semana 16
    ? Cambio porcentual en el índice SCORAD desde el inicio hasta la semana 16
    ? Cambios en la Calidad de Vida.

    Seguridad y tolerabilidad
    ? Incidencia de acontecimientos adversos surgidos durante el tratamiento (AAST) desde el inicio del estudio y durante el periodo de tratamiento
    ? Incidencia general de AAST desde el inicio del estudio y durante el periodo de tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16
    Semana 16
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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) No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA107
    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
    France
    Germany
    Ireland
    Italy
    Netherlands
    Poland
    Russian Federation
    Slovakia
    Spain
    United Kingdom
    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 last subject
    Última visita 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 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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 290
    F.4.2.2In the whole clinical trial 330
    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)
    After a patient has completed/terminated their study participation, long term care for the participant will remain the responsibility of their primary treating physicians. Alternatively, starting at week 16, patients may be rolled over into an open-label extension (OLE) study, if they are considered eligible.
    Después de que un paciente haya completado/finalizado su participación en el estudio, su cuidado médico a largo plazo será responsabilidad de su médico de cabecera. Alternativamente, a partir de la semana 16, los pacientes podrán pasar a un estudio de extensión abierto (OLE), si se consideran aptos.
    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 Decision2016-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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