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    Summary
    EudraCT Number:2016-003637-14
    Sponsor's Protocol Code Number:GLPG0634-CL-224
    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:2016-12-13
    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 number2016-003637-14
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 16 weeks to subjects with moderately to severely active psoriatic arthritis
    Estudio en fase II, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de filgotinib administrado durante 16 semanas a 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
    A study to assess the efficacy and safety of the study drug, filgotinib, administered for 16 weeks to subjects with moderately to severely active psoriatic arthritis
    Estudio para evaluar la eficacia y la seguridad del medicamento del estudio, filgotinib, administrado durante 16 semanas a sujetos con artritis psoriásica activa de moderada a grave
    A.4.1Sponsor's protocol code numberGLPG0634-CL-224
    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 number0034620772751
    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
    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
    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 19.0
    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
    Evaluate the effect of filgotinib compared to placebo on the signs and symptoms of peripheral arthritis, as assessed by the ACR20 at Week 16.
    Evaluar el efecto de filgotinib en comparación con placebo en los signos y síntomas de la artritis periférica, determinado por ACR20 en la semana 16.
    E.2.2Secondary objectives of the trial
    Evaluate the effect of filgotinib compared to placebo on:
    - The signs and symptoms of psoriatic arthritis
    - The signs and symptoms of peripheral arthritis
    - Psoriasis
    - Enthesitis
    - Dactylitis
    - Physical function
    - Fatigue and general quality of life

    Evaluate the safety and tolerability of filgotinib.
    Evaluar el efecto de filgotinib en comparación con placebo en:
    - Los signos y síntomas de la artritis psoriásica
    - Los signos y síntomas de la artritis periférica
    - Psoriasis
    - Entesitis
    - Dactilitis
    - Función física
    - Cansancio y calidad de vida general
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Subjects will have the option to participate in a PK sub-study (separate consent), requiring additional blood samples to be collected at different time points as specified in the protocol.
    At selected investigational sites, subjects will have the option to participate in a (lesional/nonlesional) skin biopsy research sub-study (separate consent). Skin biopsies will be obtained at different time points as specified in the protocol.
    Para los sujetos que den su consentimiento para participar en el subestudio de FC opcional, se extraerán muestras de sangre en varios momentos especificados en el protocolo.
    En los centros de investigación seleccionados, los sujetos deben dar su consentimiento para participar en una investigación opcional de biopsia cutánea (con o sin lesiones). Las biopsias cutáneas se obtendrán en los momentos especificados en el protocolo.
    E.3Principal inclusion criteria
    • Male or female subjects who are ≥18 years of age, on the day of signing informed consent.
    • Diagnosis of psoriatic arthritis for at least 12 weeks prior to screening, and currently meet Classification Criteria for Psoriatic Arthritis (CASPAR) (see protocol).
    • Have active psoriatic arthritis defined as ≥5 swollen joints (from a 66 swollen joint count [SJC]) and ≥5 tender joints (from a 68 tender joint count [TJC]) at Screening and Baseline (measurable dactylitis of a digit counts as a single swollen joint and if tender, then also a single tender joint).
    • Have had a history of documented plaque psoriasis or currently active plaque psoriasis
    • If using cDMARD therapy, subjects are only permitted to use one of the following drugs (methotrexate, leflunomide, sulfasalazine, hydroxychloroquine or chloroquine) and must have been on it for 12 weeks prior to screening, with a stable dose (including stable route of administration) for at least 4 weeks prior to baseline.
    • Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use highly effective methods of contraception as described in the protocol.
    • Sujetos de ambos sexos con una edad ≥18 el día que se firme el consentimiento informado.
    • Diagnóstico de artritis psoriásica al menos 12 semanas antes de la selección y que actualmente cumplan los Criterios de clasificación de la artritis psoriásica (CASPAR) (ver protocolo).
    • Padecer APs activa definida como ≥5 articulaciones inflamadas (de un recuento de 66 articulaciones inflamadas) y ≥5 articulaciones dolorosas (de un recuento de 68 articulaciones dolorosas) en la selección y en el inicio (la dactilitis mensurable de un dedo cuenta como una única articulación inflamada y, si presenta sensibilidad, también una única articulación dolorosa).
    • Haber tenido antecedentes de psoriasis en placas documentada o psoriasis en placas activa en la actualidad.
    • Si recibe tratamiento con FARMEc, solo se permite a los sujetos que utilicen uno de los siguientes fármacos (metotrexato, leflunomida, sulfasalazina, hidroxicloroquina o cloroquina) y deben haberlo tomado durante las 12 semanas previas a la selección, con una dosis estable (incluida la vía estable de administración) durante al menos 4 semanas antes del inicio.
    • Los hombres y las mujeres en edad fértil que mantengan relaciones heterosexuales deben comprometerse a utilizar métodos anticonceptivos muy eficaces (tal como se describe en el protocolo).
    E.4Principal exclusion criteria
    • Use of JAK inhibitors, investigational or approved, at any time, including filgotinib;
    • Prior use of more than one TNF inhibitor (including proposed biosimilars with demonstrated equivalence to an approved TNF inhibitor for efficacy in a clinical study), at any time. Prior use of one TNF inhibitor is allowed, with the following minimum washout periods prior to screening:
    - Etanercept: 4 weeks
    - Adalimumab, certolizumab pegol, golimumab: 8 weeks
    - Infliximab: 12 weeks;
    • Use of oral steroids at a dose >10 mg/day of prednisone or prednisone equivalent or at a dose that hasn’t been stable for at least 4 weeks prior to Baseline;
    • Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronate) within 4 weeks prior to screening;
    • Use of more than 1 NSAID or cyclooxygenase-2 (COX-2) inhibitor. If an NSAID or COX-2 inhibitor is used, it must not exceed maximum doses permitted as per local labeling and must have been used at a stable dose for at least 2 weeks prior to baseline. In addition, subjects are permitted to take acetylsalicylic acid at a dose of ≤325 mg q.d. for cardiac prophylaxis;
    • Have undergone surgical treatment for psoriatic arthritis including synovectomy and arthroplasty in more than 3 joints and/or within the last 12 weeks prior to screening
    • Presence of very poor functional status or unable to perform self-care.
    • Administration of a live or attenuated vaccine within 12 weeks prior to baseline.
    • Uso en cualquier momento de inhibidores de JAK, en investigación o autorizados, incluido filgotinib.
    • Uso previo en cualquier momento de más de un inhibidor de TNF (incluidos biosimilares propuestos con equivalencia demostrada de un inhibidor de TNF autorizado para la eficacia en un estudio clínico). Se permite el uso anterior de un inhibidor de TNF con los siguientes periodos mínimos de reposo farmacológico previos a la selección:
    i. Etanercept: 4 semanas
    ii. Adalimumab, certolizumab pegol, golimumab: 8 semanas
    iii. Infliximab: 12 semanas
    • Uso de corticoesteroides orales en una dosis de >10 mg/día de prednisona o equivalente de prednisona o en una dosis que no se haya mantenido estable durante al menos 4 semanas antes del inicio.
    • Cualquier tratamiento mediante inyecciones intrarticulares (p. ej., corticoesteroides, hialuronato) en las 4 semanas previas a la selección.
    • Uso de más de un antinflamatorio no esteroideo (AINE) o inhibidor de la ciclooxigenasa-2 (COX-2). Si se utiliza un AINE o inhibidor de COX-2, no se debe exceder el número máximo de dosis permitidas según la ficha técnica local y deben haberse utilizado siguiendo una dosis estable durante al menos las 2 semanas previas al inicio. Además, se permite que los sujetos tomen ácido acetilsalicílico en una dosis de ≤325 mg una vez al día para profilaxis cardíaca.
    • Haberse sometido a un tratamiento quirúrgico para la APs, incluidas la sinovectomía y la artroplastia en más de 3 articulaciones o en las últimas 12 semanas previas a la selección.
    • Presencia de estados funcionales muy deficientes o incapacidad para llevar a cabo el cuidado personal.
    • Administración de una vacuna viva o atenuada en el plazo de 12 semanas antes del inicio.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients achieving ACR20 at week 16
    Porcentaje de pacientes que logran ACR20 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)
    Efficacy:
    • The signs and symptoms of psoriatic arthritis, as assessed by the proportion of subjects achieving MDA.
    • The signs and symptoms of peripheral arthritis, as assessed by:
    - Proportion of subjects achieving ACR20, ACR50 and ACR70 response rates
    - Change from 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 baseline in SDAI
    - Change from baseline in CDAI
    - EULAR response and remission rates
    - PsARC response rates
    • Psoriasis, as assessed by:
    - Change from baseline in PASI and proportions of subjects with PASI50, PASI75, PASI90, and PASI100 in those subjects with psoriasis involving ≥3% BSA at baseline
    - Change from baseline in Physician’s Global Assessment of psoriasis in those subjects with psoriasis involving ≥3% BSA at baseline
    - Change from baseline in Patient’s Global Assessment of psoriasis in those subjects with psoriasis involving ≥3% BSA at baseline
    - Change from baseline in mNAPSI in those subjects with psoriatic nail involvement at baseline
    - Change from baseline of pruritus NRS in those subjects with psoriasis involving ≥3% BSA at baseline
    - Proportion of subjects achieving a pruritus NRS response (improvement in pruritus NRS score of ≥3)
    • Enthesitis, as assessed by change from baseline in the SPARCC Enthesitis Index in those subjects with enthesitis at baseline
    • Dactylitis, as assessed by change from baseline in LDI in those subjects with dactylitis at baseline
    • Physical function, as assessed by change from baseline in HAQ-DI
    • Fatigue and general quality of life, as assessed by change from baseline in FACIT-Fatigue, SF-36, and PsAID scores
    • Signs and symptoms of peripheral arthritis and physical function, as assessed by change from baseline in individual components of the ACR response criteria

    Safety:
    Incidence of AEs, SAEs, and discontinuations due to AEs, as well as changes in laboratory results, ECGs, physical examination, body weight and vital signs.
    Eficacia:
    • Signos y síntomas de la artritis psoriásica, determinado a través de la proporción de sujetos que logran MDA.
    • Signos y síntomas de la artritis periférica, determinado por:
    - proporción de sujetos que logran tasas de respuesra de ACR20, ACR50 y ACR70;
    - cambio con respecto al inicio en la 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 en el SDAI;
    - cambio con respecto al inicio en el CDAI;
    - respuesta de EULAR y tasa de remisión;
    - tasas de respuesta de PsARC.
    • Psoriasis, evaluada a través de:
    - cambio con respecto al inicio en el PASI y proporciones de sujetos con PASI50, PASI75, PASI90 y PASI100 en los sujetos con psoriasis que afecta al ≥3 % de la SC en el inicio;
    - cambio con respecto al inicio en la Evaluación global de la psoriasis por parte del médico en los sujetos con psoriasis que afecta al ≥3 % de la SC en el inicio;
    - cambio con respecto al inicio en la Evaluación global de la psoriasis por parte del paciente en los sujetos con psoriasis que afecta al ≥3 % de la SC en el inicio;
    - cambio con respecto al inicio en el mNAPSI en los sujetos con afectación psoriásica ungueal en el inicio;
    - cambio con respecto al inicio de la EVN de prurito en los sujetos con psoriasis que afecta al ≥3 % de la SC en el inicio;
    - proporción de sujetos que logran una respuesta de la EVN de prurito (mejoría en la puntuación de la EVN de prurito de ≥3).
    • Entesitis, evaluada por el cambio con respecto al inicio en el Índice entesítico del SPARCC en los sujetos con entesitis en el inicio.
    • Dactilitis. evaluada por el cambio con respecto al inicio en el LDI en los sujetos con dactilitis en el inicio.
    • Función física, evaluada por el cambio con respecto al inicio en el HAQ-DI.
    • Cansancio y calidad de vida general, evaluado por el cambio con respecto al inicio en las puntuaciones de FACIT-Cansancio, SF-36 y PsAID.
    • Signos y síntomas de artritis periférica y fun ción física, evaluados por el cambio con respecto al inicio en los componentes individuales de los criterios de respuesta del ACR.

    Seguridad:
    Incidencia de acontecimientos adversos (AA), acontecimientos adversos graves e interrupciones debidas a AA, así como cambios en los resultados a´nalíticos, en los electrocardiogramas (ECG), en la exploración física, en el peso corporal y en las constantes vitales a lo largo del tiempo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various time points throughout the trial as specified in the protocol
    En los momentos a lo largo del estudio que se especifican 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 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 trial2
    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
    Upon completion of the 16-weeks treatment period, subjects (who did not discontinue assigned study drug early) will have the possibility to enroll in an open-label Long-Term Extension (LTE) study. For those subjects not entering the open-label LTE, the study is concluded when the last subject has completed the follow-up period lasting until 4 weeks after the last dose.
    Tras la finalización del periodo de tratamiento de 16 semanas, los sujetos (aquellos que no hayan interrumpido antes de tiempo el tratamiento asignado del fármaco del estudio) podrán participar en un estudio abierto de extensión a largo plazo (ELP). Los sujetos que no participen en el estudio abierto de ELP, el estudio concluye cuando el último sujeto ha completado el período de seguimiento 4 semanas después de la administración de la última dosis.
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 105
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 19
    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 92
    F.4.2.2In the whole clinical trial 124
    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)
    Upon completion of the 16-week treatment period, subjects (who did not discontinue assigned study drug early) will have the possibility to enroll in an open-label LTE study. This study will be described in a separate protocol.

    For subjects that will not participate in the LTE study there is no post trial treatment plan; treatment will revert to the standard of care.
    Tras la finalización del periodo de tratamiento de 16 semanas, los sujetos (aquellos que no hayan interrumpido antes de tiempo el tratamiento asignado del fármaco del estudio) podrán participar en un estudio abierto de extensión a largo plazo (ELP). Este estudio se describirá en un protocolo independiente. No existe tratamiento post-estudio, por lo que los sujetos que no deseen participar en el estudio de ELP recibirán el tratamiento estándar una vez finalizada su participación en el estudio.
    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 Decision2017-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-12
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