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    Summary
    EudraCT Number:2019-002021-29
    Sponsor's Protocol Code Number:GS-US-431-4567
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2020-02-24
    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 number2019-002021-29
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Have an Inadequate Response or are Intolerant to Biologic DMARD Therapy
    Estudio de fase 3, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de filgotinib en pacientes con artritis psoriásica activa que han presentado respuesta insuficiente o que son intolerantes al tratamiento con fármacos biológicos antirreumáticos modificadores de enfermedad
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Have an Inadequate Response or are Intolerant to Biologic DMARD Therapy
    Estudio de fase 3, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de filgotinib en pacientes con artritis psoriásica activa que han presentado respuesta insuficiente o que son intolerantes al tratamiento con fármacos biológicos antirreumáticos modificadores de enfermedad
    A.4.1Sponsor's protocol code numberGS-US-431-4567
    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 SponsorGilead Sciences 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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34913789830
    B.5.5Fax number+441223897284
    B.5.6E-mailclinical.trials@gilead.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 nameFilgotinib
    D.3.2Product code GS-6034
    D.3.4Pharmaceutical form Film-coated 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 INNFILGOTINIB
    D.3.9.1CAS number 1802998-75-9
    D.3.9.2Current sponsor codeGS-6034-02
    D.3.9.4EV Substance CodeSUB182273
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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 nameFilgotinib
    D.3.2Product code GS-6034
    D.3.4Pharmaceutical form Film-coated 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 INNFILGOTINIB
    D.3.9.1CAS number 1802998-75-9
    D.3.9.2Current sponsor codeGS-6034-02
    D.3.9.4EV Substance CodeSUB182273
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboFilm-coated 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 placeboFilm-coated 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
    Psoriatic Arthritis
    Artritis Psoriasica
    E.1.1.1Medical condition in easily understood language
    Psoriatic Arthritis
    Artritis Psoriasica
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 100000004859
    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 effect of filgotinib compared to placebo in active PsA as assessed by the ACR20 response at Week 12
    • Evaluar el efecto de filgotinib en comparación con un placebo en la artritis psoriásica (APs) activa en la semana 12.
    E.2.2Secondary objectives of the trial
    •To evaluate the effect of filgotinib on core domains of PsA (e.g. peripheral arthritis, psoriatic skin disease, enthesitis and dactylitis) as assessed by MDA, VLDA, ACR responses, PASI including BSA responses, SPARCC Enthesitis Index and LEI, LDI including TDC, PASDAS, DAPSA, mNAPSI, and PhGAP
    •To evaluate the effect of filgotinib on physical function in active PsA as assessed by HAQ-DI
    •To evaluate the effect of filgotinib on fatigue and quality of life in active PsA as assessed by FACIT-Fatigue, SF-36v2, and PsAID-12
    •To evaluate the safety and tolerability of filgotinib
    • Evaluar el efecto de filgotinib en los dominios fundamentales de la APs( Ej. Artitis periférica, artritis periférica, enfermedad psoriásica de la piel, entesitis y dactilitis), evaluados mediante las escalas MDA, VLDA, las respuestas ACR, PASI incluida la SC, el índice de entesitis del Spondyloarthritis Research Consortium of Canada y el índice de entesitis de Leeds (índice de entesitis SPARCC y LEI), LDI, PASDAS, DAPSA, mNAPSI y PhGAP.
    • Evaluar el efecto de filgotinib sobre la función física en la APs activa mediante HAQ-DI.
    • Evaluar el efecto de filgotinib sobre el cansancio y la calidad de vida en la APs activa mediante FACIT-Cansancio, el SF-36v2 y PsAID-12.
    • Evaluar la seguridad y la tolerabilidad de filgotinib.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There is an optional PK sub-study
    Hay un subestudio de PK opcional
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for participation in this
    study.
    •Male or female subjects who are 18-75 years of age (20-75 years of age at sites in Japan), on the day of signing initial informed consent
    •Meet Classification Criteria for Psoriatic Arthritis (CASPAR) and have a history consistent with PsA ≥6 months at Screening
    •Have active PsA defined as ≥3 swollen joints (from a 66 swollen joint count [SJC]) and ≥3 tender joints (from a 68 tender joint count [TJC]) at Screening and Day 1;these may or may not be the same joints at Screening and Day 1
    •Must have a documented history or active signs of at least one of the following at Screening:
    Plaque psoriasis or nail changes attributed to psoriasis
    •Have had inadequate response or intolerance to at least one and not more than 3 bioDMARDs administered for the treatment of PsA, as per local guidelines / standard of care
    •Prior to the first dose of study drug on day 1, treatment with bioDMARDs should have been discontinued as outlined in Section 4.2 of the Protocol
    •If continuing csDMARD(s) during the study, subjects are permitted to use only a maximum of 2 of the drugs as outlined in Section 4.2 of the Protocol and must have been on this treatment for ≥12 consecutive weeks prior to Screening, with a stable dose and route of administration (defined as no change in prescription) for ≥4 weeks prior to Day 1
    •Concomitant NSAIDs or corticosteroids are permitted as specified in Sections 4.2 and 4.3 of the Protocol
    •Meet one of the TB screening criteria as described in Section 4.2 of the Protocol.
    •Able and willing to sign the informed consent as approved by the IRB/IEC
    • Subjects receiving non-prohibited medication for any reason should be on a stable dose prior to the first administration of the study drug on day 1
    •A negative serum pregnancy test result at the Screening Visit and negative urine pregnancy test result at the Day 1 Visit are required for female subjects of child bearing potential
    •Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
    •Lactating females must agree to discontinue nursing before the study drug is administered
    Criterios de inclusión fundamentales:
    • Varones o mujeres de 18-75 años (20-75 años en los centros de Japón) el día de la firma del consentimiento informado inicial.
    •Cumplen los Criterios de clasificación de la artritis psoriásica (CASPAR) y antecedentes compatibles con APs ≥ 6 meses en la selección
    • Presentan APs activa, definida como ≥ 3 articulaciones inflamadas (a partir de un recuento de 66 articulaciones inflamadas [SJC]) y ≥ 3 articulaciones dolorosas (a partir de un recuento de 68 articulaciones dolorosas [TJC]) en la selección y el día 1; las articulaciones pueden ser o no las mismas el día de la selección y el día 1
    • Deben tener antecedentes documentados o signos activos de al menos uno de los siguientes en la selección:
    Psoriasis en placas o alteraciones ungueales atribuidas a la psoriasis
    • Han tenido una respuesta insuficiente (falta de eficacia después de ≥ 12 semanas de tratamiento) o son intolerantes al menos a uno y no más de 3 bioFARME administrados para el tratamiento de la APs o la psoriasis, de acuerdo con las directrices/normas asistenciales locales.
    • Antes de la primera dosis del fármaco del estudio el día 1, deberá haberse suspendido el tratamiento con bioFARME tal como se describe en la sección 4.2
    • Si los sujetos siguen recibiendo FARMEsc durante el estudio, se les permitirá utilizar únicamente un máximo de 2 de los fármacos que se describen en la sección 4.2 y deberán haber recibido este tratamiento durante ≥ 12 semanas consecutivas antes de la selección, con una dosis y una vía de administración estables (es decir, sin ningún cambio en la prescripción) durante ≥ 4 semanas antes del día 1.
    • Se permite el uso concomitante de AINE o corticosteroides, que deberán mantenerse estables según se especifica en las secciones 4.2y 4.3. del protocolo
    •Cumplir uno de los criterios de selección TB como se describen en la Sección 4.2 del Protocolo.
    • Consciente y capaz de firmar el consentimiento informado aprobado por el CEIm
    • Los pacientes que reciban medicación no prohibida por cualquier razón deberían estar en una dosis estable antes de la primera administración del fármaco del estudio en el día 1
    • Resultado de prueba de embarazo negativa (muestra de sangre en la selección y muestra de orina en la Visita del Día 1) son requeridas en las mujeres que puedan tener hijos
    • Pacientes hombres y pacientes mujeres en edad fértil que mantengan relaciones heterosexuales deben estar de acuerdo en utilizar el/los método/s anticonceptivos especificados en el protocolo.
    • Mujeres lactantes deben consentir discontinuar la lactancia antes de que el medicamento sea administrado
    E.4Principal exclusion criteria
    Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
    •Known hypersensitivity to the study drug, the metabolites or the formulation excipients
    •Prior PsA or psoriasis treatment with ≥4 bioDMARDs
    •Prior exposure to a JAK inhibitor >2 doses
    •Any active / recent infection, as specified in Section 4.3 of the Protocol
    •Any chronic and / or uncontrolled medical condition that would put the subject at increased risk during study participation or circumstances which may make a subject unlikely or unable to complete or comply with study procedures and requirements, per investigator judgement
    •Any moderately to severely active musculoskeletal or skin disorder other than PsA or plaque psoriasis that would interfere with assessment of study parameters, as per judgement of the investigator NOTE: Prior history of reactive arthritis or axial spondyloarthritis is permitted if there is documentation of change in diagnosis to PsA or additional diagnosis of PsA
    •Any history of an inflammatory arthropathy with onset before age 16 years old
    •Active autoimmune disease other than those listed above, that would interfere with assessment of study parameters or increase risk to the subject by participating in the study (e.g. uveitis, inflammatory bowel disease, uncontrolled thyroiditis, systemic vasculitis, transverse myelitis), per judgement of investigator
    •Presence of any extra-articular manifestations typically associated with rheumatoid arthritis (RA), such as rheumatoid nodules, rheumatoid lung, or other signs / symptoms, as per judgement of investigator
    •Pregnancy or nursing females
    •Active drug or alcohol abuse, as per judgement of investigator
    •Unwilling or unable to follow protocol requirements
    Los sujetos que cumplan con cualquiera de los siguientes criterios de exclusión no deben ser inscritos en este estudio:
    •Hipersensibilidad conocida al fármaco del estudio, a los metabolitos o a excipientes de formulación
    •Tratamiento previo de APs o psoriasis con ≥4 bioDMARD
    •Exposición previa a más de dos dosis de un inhibidor de JAK.
    •Cualquier infección activa o reciente, según se especifica en la sección 4.3.
    • Cualquier trastorno médico crónico o no controlado que suponga un mayor riesgo para el sujeto durante su participación en el estudio o circunstancias que puedan hacer improbable o impedir que el sujeto complete el estudio o cumpla los procedimientos y requisitos del estudio, según el criterio del investigador.
    • Cualquier trastorno musculoesquelético o cutáneo de actividad moderada a intensa, aparte de la APs o la psoriasis en placas, que pueda interferir en la evaluación de los parámetros del estudio, según el criterio del investigador. NOTA: se permiten los antecedentes de artritis reactiva o espondiloartritis axial si se ha documentado el cambio del diagnóstico a APs o si también se ha diagnosticado APs
    • Antecedentes de artropatía inflamatoria que comenzó antes de los 16 años de edad.
    • Enfermedad autoinmunitaria activa distinta de las enumeradas anteriormente, que pudiera interferir en la evaluación de los parámetros del estudio o aumentar el riesgo para el sujeto si participa en el estudio (p. ej., uveítis, enfermedad inflamatoria intestinal, tiroiditis no controlada, vasculitis sistémica, mielitis transversa), según el criterio del investigador.
    • Presencia de manifestaciones extraarticulares asociadas habitualmente a la artritis reumatoide (AR), como nódulos reumatoides, pulmón reumatoide u otros signos/síntomas, según el criterio del investigador.
    • Mujeres embarazadas o en período de lactancia
    • Alcoholismo o toxicomanía activos, según el criterio del investigador.
    • Incapacidad o falta de disposición para cumplir los requisitos del protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the ACR20 response at Week 12.
    El objetivo principal es la respuesta ACR20 en la semana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    The key secondary endpoints include:
    •ACR50 response at Week 12
    •Change from Baseline in HAQ-DI at Week 12
    •Change from Baseline in SF-36v2 physical component summary (PCS) at Week 16
    •Change from Baseline in SPARCC Enthesitis Index at Week 16, in subjects with enthesitis at Baseline
    •Psoriasis Area and Severity Index 75% improvement (PASI75) response at Week 16, in subjects with psoriasis covering ≥3% of the BSA at Baseline
    •MDA response at Week 16
    •Change from Baseline in FACIT-Fatigue at Week 16
    •Change from Baseline in LDI at Week 16, in subjects with dactylitis at Baseline
    Los objetivos secundarios clave incluyen:
    •Respuesta ACR50 en la semana 12.
    •Variación de la puntuación HAQ-DI entre el momento basal y la semana 12.
    •Variación del resumen del componente físico (PCS) del SF-36v2 entre el momento basal y la semana 16.
    •Variación del índice de entesitis SPARCC entre el momento basal y la semana 16 en los sujetos con entesitis en el momento basal.
    •Mejoría del 75% en el índice de intensidad y extensión de la psoriasis (PASI75) en la semana 16 en los sujetos con psoriasis que cubra ≥ 3% de la SC en el momento basal.
    •Respuesta MDA en la semana 16.
    •Variación de la escala FACIT-Cansancio entre el momento basal y la semana 16.
    •Variación de la puntuación LDI entre el momento basal y la semana 16 en los sujetos con dactilitis en el momento basal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12, week 16
    Semana 12, 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 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 No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    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
    Argentina
    Australia
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Hong Kong
    Hungary
    Italy
    Japan
    Korea, Republic of
    Mexico
    Poland
    Spain
    Taiwan
    United Kingdom
    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
    End of study is defined as when the last subject has completed all scheduled dosing plus their safety follow-up visit or the study has been terminated
    El final del estudio se define como el momento en el que el último sujeto ha completado todas las dosis programadas más su visita de seguimiento de seguridad o el estudio ha finalizado
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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: 280
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 188
    F.4.2.2In the whole clinical trial 390
    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)
    The long term care of the participant will remain the responsibility of the participant and/or their primary treating physician
    La atención a largo plazo del participante seguirá siendo responsabilidad del participante y / o de su médico tratante primario.
    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 Decision2020-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-18
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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