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    Summary
    EudraCT Number:2017-000545-52
    Sponsor's Protocol Code Number:GLPG0634-CL-225
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-06-22
    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 number2017-000545-52
    A.3Full title of the trial
    A multicenter, open-label, long-term extension safety and efficacy study of filgotinib treatment in subjects with moderately to severely active psoriatic arthritis
    Estudio de extensión, multicéntrico, abierto, para evaluar la eficacia y la seguridad a largo plazo del tratamiento con filgotinib en sujetos con artritis psoriásica activa de moderada a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term open-label study of filgotinib in subjects with psoriatic arthritis
    Estudio abierto de extensión con filgotinib en sujetos con artritis psoriásica
    A.4.1Sponsor's protocol code numberGLPG0634-CL-225
    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 SponsorGalapagos Nv
    B.1.3.4CountryBelgium
    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 supportGalapagos NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Raúl Veiga Cabello
    B.5.2Functional name of contact pointNational Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressHU de Fuenlabrada, Servicio de Reumatología, Camino del Molino 2
    B.5.3.2Town/ cityFuenlabrada, Madrid
    B.5.3.3Post code28942
    B.5.3.4CountrySpain
    B.5.4Telephone number+34620772751
    B.5.6E-mailraul.veiga@salud.madrid.org
    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 GLPG0634
    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.3.9.3Other descriptive nameFilgotinib
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Psoriatic arthritis
    Artritis psoriásica
    E.1.1.1Medical condition in easily understood language
    Psoriatic arthritis
    Artritis psoriásica
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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 long-term safety and tolerability of filgotinib in patients with psoriatic arthritis (PsA).
    Evaluar la seguridad y tolerabilidad a largo plazo de filgotinib en sujetos con artritis psoriásica (APs)
    E.2.2Secondary objectives of the trial
    - To evaluate the long-term efficacy of filgotinib in patients with PsA.
    - To evaluate the long-term effects of filgotinib administration on disability, fatigue and quality of life in patients with PsA.
    - Evaluar la eficacia a largo plazo de filgotinib en sujetos con APs.
    - Evaluar los efectos a largo plazo de la administración de filgotinib sobre la discapacidad, el cansancio y la calidad de vida de los pacientes con APs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female subjects who are ≥18 years of age, having completed the 16 weeks of treatment in the qualifying core study GLPG0634-CL-224 and who may benefit from filgotinib long-term treatment according to the investigator’s judgment.
    • Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to continue to use highly effective methods of contraception as described in the protocol.
    • Able and willing to sign the informed consent form (ICF), as approved by the Independent Ethics Committee (IEC) and agree to the schedule of assessments.
    • Sujetos hombres o mujeres que tengan ≥18 años de edad, que hayan completado las 16 semanas de tratamiento en el estudio principal de aptitud GLPG0634-CL-224 y que puedan beneficiarse del tratamiento a largo plazo con filgotinib a juicio del investigador.
    • Los hombres y las mujeres en edad fértil que tengan relaciones heterosexuales deben aceptar c métodos anticonceptivos de gran eficacia (como se describe en el protocolo).
    • Ser capaces y estar dispuestos a firmar el formulario de consentimiento informado (FCI) según lo aprobado por el comité ético de independiente y consentir en realizar el calendario de evaluaciones.
    E.4Principal exclusion criteria
    • Subjects who are deemed not to be benefitting from the study drug based upon lack of improvement or worsening of their symptoms. Local guidelines for subject treatment need to be followed.
    • Persistent abnormal laboratory values associated with the use of the study drug (including and not limited to hematology, liver and renal function values), according to the investigator’s clinical judgment.
    • Subjects who discontinued the qualifying core study GLPG0634-CL-224 due to safety or tolerability issues.
    • Subjects who require immunization with live/live attenuated vaccine.
    • Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than psoriatic arthritis, except for Sjögren’s syndrome.
    • Subjects with symptoms suggestive of uncontrolled hypertension, congestive heart failure, uncontrolled diabetes, cerebrovascular accident, myocardial infarction, unstable angina, unstable arrhythmia or any other cardiovascular condition since the inclusion to the GLPG0634-CL-224 study.
    • Subjects with symptoms suggestive of gastrointestinal tract ulceration and/or active diverticulitis since the inclusion to the GLPG0634-CL-224 study.
    • Subjects with symptoms suggestive of possible lymphoproliferative disease including lymphadenopathy or splenomegaly since the inclusion to the GLPG0634-CL-224 study.
    • Subjects with symptoms suggestive of malignancy since the inclusion to the GLPG0634-CL-224 study.

    Reference is made to the protocol for a complete overview of the exclusion criteria.
    • Los sujetos que se considere que no se beneficiarán de la medicación del estudio basándose en la ausencia de mejora o en el empeoramiento de sus síntomas. Es necesario seguir las directrices locales para el tratamiento del sujeto.
    • Valores analíticos anómalos persistentes asociados al uso del fármaco del estudio (incluidos, entre otros: valores de hematología, de función hepática y de función renal), de acuerdo con el juicio clínico del investigador.
    • Los sujetos que interrumpieron su participación en el estudio principal de aptitud GLPG0634-CL-224 a consecuencia de problemas de seguridad o tolerabilidad.
    • Los sujetos que requieran vacunación con vacunas atenuadas o vacunas elaboradas con microbios vivos.
    • Diagnóstico de enfermedad autoinmune reumática o enfermedad articular inflamatoria distinta a la APs, excepto el síndrome de Sjögren.
    • Sujetos con síntomas que sugieran hipertensión no controlada (≥160/95 mmHg), insuficiencia cardíaca congestiva (estado de clase III o IV de la Asociación Cardiológica de Nueva York), diabetes no controlada, accidente cerebrovascular, infarto de miocardio, angina inestable, arritmia inestable o cualquier otra enfermedad cardiovascular desde la inclusión en el estudio GLPG0634-CL-224.
    • Sujetos con síntomas que sugieran úlceras en el tubo gastrointestinal y/o diverticulitis activa desde la inclusión en el estudio GLPG0634-CL-224.
    • Sujetos con síntomas que sugieran una posible enfermedad linfoproliferativa, incluidas la linfadenopatía o esplenomegalia desde la inclusión en el estudio GLPG0634-CL-224.

    Se hace referencia al protocolo para una visión completa de los criterios de exclusíón.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of AEs, SAEs, and discontinuations due to AEs, as well as changes in laboratory results, ECGs, body weight and vital signs over time
    Incidencia de acontecimientos adversos (AA), acontecimientos adversos graves (AAG) e interrupciones debidas a AA, así como cambios en los resultados analíticos, en los electrocardiogramas (ECG), en el peso corporal y en las constantes vitales a lo largo del tiempo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Various timepoints throughout the trial as specified in the protocol
    Varios momentos de evaluación a lo largo del ensayo especificados en el protocolo
    E.5.2Secondary end point(s)
    • Signs and symptoms of PsA:
    - Proportion of subjects achieving MDA.
    • Signs and symptoms of peripheral arthritis:
    - Proportion of subjects achieving ACR20, ACR50 and ACR70 response rates.
    - Change from core baseline in DAS28(CRP).
    - Proportion of subjects who achieve low disease activity (defined as DAS28[CRP] ≤3.2) and remission (defined as DAS28[CRP] <2.6).
    - Change from core baseline in SDAI.
    - Change from core baseline in CDAI.
    - EULAR response and remission rates.
    - PsARC response rates.
    • Psoriasis in those subjects with psoriasis involving ≥3% Body Surface Area (BSA), or with psoriatic nail involvement (only for mNAPSI), at core baseline:
    - Change from core baseline in PASI and proportions of subjects with PASI50, PASI75, PASI90, and PASI100.
    - Change from core baseline in Physician’s Global Assessment of psoriasis.
    - Change from core baseline in Patient’s Global Assessment of psoriasis.
    - Change from core baseline in mNAPSI.
    - Change from core baseline in pruritus NRS.
    - Proportion of subjects achieving a pruritus NRS response (improvement in pruritus NRS score of ≥3).
    • Enthesitis in those subjects with enthesitis at core baseline:
    - Change from core baseline in the SPARCC Enthesitis Index.
    • Dactylitis in those subjects with dactylitis at core baseline:
    - Change from core baseline in LDI.
    • Physical function:
    - Change from core baseline in HAQ-DI.
    • Fatigue and general quality of life at Week 4, Week 52, Week 100 and Week 148:
    - Change from core baseline in FACIT-Fatigue, SF-36, and PsAID scores.
    • Signs and symptoms of peripheral arthritis and physical function:
    - Change from core baseline in individual components of the ACR response criteria
    − Signos y síntomas de la APs:
    • Proporción de sujetos que logran una actividad mínima de la enfermedad.
    − Signos y síntomas de la artritis periférica:
    • Proporción de sujetos que alcanzan los índices de respuesta del Colegio Americano de Reumatología (ACR) 20, ACR50 y ACR70.
    • Cambio con respecto al inicio del estudio principal en la puntuación de actividad de la enfermedad en 28 articulaciones basada en la proteína C reactiva (DAS28-CRP).
    • Proporción de sujetos que logran baja actividad de la enfermedad (definida como DAS28[CRP] ≤3,2) y remisión (definida como DAS28[CRP] <2,6).
    • Cambio con respecto al inicio del estudio principal en el índice simplificado de actividad de la enfermedad (SDAI).
    • Cambio con respecto al inicio del estudio principal en el índice clínico de actividad de la enfermedad (CDAI).
    • Índices de respuesta y remisión de la Liga Europea Contra el Reumatismo (EULAR).
    • Índices de respuesta de la respuesta de la artritis psoriásica (PsARC).
    − Psoriasis en aquellos sujetos con psoriasis que afecte a ≥3 % del área de superficie corporal (ASC) o con afectación psoriásica ungueal (solo para el índice de área y severidad de la psoriasis ungueal modificado [mNAPSI]), en la puntuación inicial del estudio principal:
    • Cambio con respecto al inicio del estudio principal en el índice de área y severidad de la psoriasis (PASI) y proporciones de sujetos con PASI50, PASI75, PASI90 y PASI100.
    • Cambio con respecto al inicio del estudio principal en la evaluación general de la psoriasis por parte del médico.
    • Cambio con respecto al inicio del estudio principal en la evaluación general de la psoriasis por parte del paciente.
    • Cambio con respecto al inicio del estudio principal en el mNAPSI.
    • Cambio con respecto al inicio del estudio principal en la escala de valoración numérica (EVN) de prurito.
    • Proporción de sujetos que logran una respuesta de la EVN de prurito (mejoría en la puntuación de la EVN de prurito de ≥3).
    − Entesitis en aquellos sujetos con entesitis al inicio del estudio principal:
    • Cambio con respecto al inicio del estudio principal en el índice de entesitis del Consorcio de investigación sobre la espondiloatritis de Canadá (SPARCC).
    − Dactilitis en aquellos sujetos con dactilitis al inicio del estudio principal:
    • Cambio con respecto al inicio del estudio principal en el índice de dactilitis de Leeds (LDI).
    − Función física:
    • Cambio con respecto al inicio del estudio principal en el índice de discapacidad del cuestionario de evaluación de la salud (HAQ-DI).
    − Cansancio y calidad de vida general en la semana 4, la semana 52, la semana 100 y la semana 148:
    • Cambio con respecto al inicio del estudio principal en la Evaluación funcional del tratamiento contra las enfermedades - escala de cansancio (FACIT-Cansancio), el Cuestionario de salud resumido de 36 elementos (SF-36) y las puntuaciones de impacto de la artritis psoriásica (PsAID).
    − Signos y síntomas de artritis periférica y función física:
    • Cambio con respecto al inicio del estudio principal en los componentes individuales de los criterios de respuesta del ACR.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various timepoints throughout the trial as specified in the protocol
    Varios momentos de evaluación a lo largo del ensayo especificados en el protocolo
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Belgium
    Bulgaria
    Czech Republic
    Estonia
    Germany
    Poland
    Spain
    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 years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 105
    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)
    None, treatment will revert to the standard of care.
    Ninguno, se recibirá el tratamiento estándar.
    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 Decision2017-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-03-29
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