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    Summary
    EudraCT Number:2016-003636-21
    Sponsor's Protocol Code Number:GLPG0634-CL-223
    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:2016-12-22
    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 number2016-003636-21
    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 12 weeks to subjects with active ankylosing spondylitis
    Estudio en fase II, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de filgotinib administrado durante 12 semanas a sujetos con espondilitis anquilosante activa
    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 12 weeks to subjects with active ankylosing spondylitis
    Estudio para evaluar la eficacia y la seguridad del medicamento del estudio, filgotinib, administrado durante 12 semanas a sujetos con espondilitis anquilosante activa.
    A.4.1Sponsor's protocol code numberGLPG0634-CL-223
    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 organisationNational Coordinator
    B.5.2Functional name of contact pointDr. Raúl Veiga Cabello
    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
    ankylosing spondylitis
    espondilitis anquilosante
    E.1.1.1Medical condition in easily understood language
    ankylosing spondylitis
    espondilitis anquilosante
    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 PT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the effect of filgotinib compared to placebo on the signs and symptoms of ankylosing spondylitis, as assessed by the ASDAS at Week 12.
    Evaluar el efecto de filgotinib en comparación con placebo en los signos y los síntomas de la espondilitis anquilosante, determinado mediante la puntuación de la actividad de la espondilitis anquilosante (ASDAS) en la semana 12.
    E.2.2Secondary objectives of the trial
    Evaluate the effect of filgotinib compared to placebo on:
    - The signs and symptoms of ankylosing spondylitis
    - Physical function
    - Spinal mobility
    - Spinal and sacroiliac joint inflammation
    - Enthesitis
    - 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 espondilitis anquilosante
    - La función física
    - La movilidad de la columna vertebral
    - La inflamación de las articulaciones vertebrales y sacroilíacas
    - La entesitis
    - La calidad de vida

    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
    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.
    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.
    E.3Principal inclusion criteria
    • Male or female subjects who are ≥18 years of age on the day of signing informed consent.
    • Diagnosis of moderate to severe ankylosing spondylitis with documented evidence of fulfilling the Modified New York (NY) criteria (see protocol) for ankylosing spondylitis at screening, having radiographic sacroiliitis confirmed by central reading (historical radiographs up to 12 months are considered appropriate).
    • Have active ankylosing spondylitis with a BASDAI ≥4 (numeric rating scale [NRS] 0-10) and spinal pain ≥4 (0-10 NRS) (based on BASDAI question 2, see protocol) at screening and baseline.
    • Screening serum high-sensitivity CRP (hsCRP) ≥0.3 mg/dL.
    • Have had a documented inadequate response to 2 or more NSAIDs including cyclooxygenase-2 (COX-2) inhibitors at the therapeutic dose range for a total duration of at least 4 weeks (less than 4 weeks permitted in cases of documented intolerance).
    • 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.
    • Hombres y mujeres que tengan ≥18 años de edad el día de la firma del consentimiento informado.
    • Diagnóstico de espondilitis anquilosante (EA) de moderada a grave con evidencia documentada de cumplimiento de los criterios modificados de Nueva York (NY) para la EA en la selección, con sacroileítis radiográfica confirmada por lectura central (se consideran adecuadas las radiografías realizadas hasta doce meses antes).
    • Tener EA activa con un BASDAI ≥4 (escala de clasificación numérica [NRS] 0-10) y dolor de la columna vertebral ≥4 (0-10 NRS) (según la pregunta 2 de BASDAI, ver protocolo) en la selección y al inicio.
    • Proteína C reactiva de alta sensibilidad (PCRas) sérica ≥0,3 mg/dl en la selección.
    • Haber tenido una respuesta inadecuada documentada a dos o más fármacos antiinflamatorios no esteroideos (AINE), incluidos los inhibidores de ciclooxigenasa-2 (COX-2) en el rango de dosis terapéutica durante al menos cuatro semanas en total (se permite menos de cuatro semanas en casos de intolerancia documentada).
    • Los hombres y las mujeres en edad fértil que tengan relaciones heterosexuales deben aceptar utilizar métodos anticonceptivos de gran eficacia (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 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;
    • Contraindication to MRI.
    • History of known or suspected complete ankylosis of the spine.
    • Presence of very poor functional status or unable to perform self-care.
    • Have undergone surgical treatment for ankylosing spondylitis within the last 12 weeks prior to screening.
    • Administration of a live or attenuated vaccine within 12 weeks prior to baseline.
    • Uso de inhibidores de JAK, en investigación o aprobados, en cualquier momento, incluido filgotinib.
    • Uso previo de más de un inhibidor del FNT (incluidos biosimilares propuestos con equivalencia demostrada a un inhibidor del FNT aprobado en cuanto a la eficacia en un estudio clínico), en cualquier momento. Se permite el uso previo de un inhibidor del FNT con los siguientes períodos mínimos de reposo farmacológico antes de la selección:
    i. Etanercept: 4 semanas
    ii. Adalimumab, certolizumab pegol, golimumab: 8 semanas
    iii. Infliximab: 12 semanas.
    • Uso de esteroides orales a una dosis >10 mg/día de prednisona o equivalente de prednisona, o a una dosis que no haya sido estable al menos durante cuatro semanas antes de la selección.
    • Cualquier tratamiento con inyecciones intraarticulares (como corticosteroide, hialuronato) en las cuatro semanas anteriores a la selección.
    • Uso de más de un AINE o inhibidor de COX-2. Si se utiliza un AINE o inhibidor de COX-2, no debe exceder las dosis máximas permitidas según la ficha técnica local y debe haberse usado a una dosis estable al menos durante dos semanas antes del inicio. Además, se permite a los pacientes tomar ácido acetilsalicílico a una dosis diaria de ≤325 mg para la profilaxis cardíaca.
    • Contraindicación a la RM.
    • Antecedentes de sospecha o de conocimiento de anquilosis completa de la columna vertebral.
    • Presencia de un estado funcional muy deficiente o incapacidad para cuidar de sí mismo.
    • Haberse sometido a una intervención quirúrgica para la EA en las últimas doce semanas antes de la selección.
    • Administración de una vacuna viva o atenuada en las doce semanas anteriores al inicio.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in the ASDAS at week 12
    Cambio con respecto al inicio en la puntuación ASDAS 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)
    Efficacy:
    • The signs and symptoms of ankylosing spondylitis, as assessed by:
    - Change from baseline in the ASDAS
    - Percentage of patients achieving ASAS20, ASAS40, ASAS 5/6 response and ASAS
    partial remission
    - Change from baseline in 44-joint count
    - Proportions of subjects who experience clinically important improvement (decrease
    of ASDAS from baseline ≥1.1), major improvement (decrease of ASDAS from
    baseline ≥2.0), and inactive disease (ASDAS <1.3)
    - Change from baseline in the individual components of the ASAS response criteria
    and the ASDAS
    - Percentage of patients achieving BASDAI 50% response (BASDAI50) and ≥2 units
    improvement in BASDAI (ΔBASDAI≥2)
    - Change from baseline in BASDAI
    • Physical function, as assessed by change from baseline in BASFI
    • Spinal mobility, as assessed by change from baseline in BASMI linear and in the individual components of the BASMI criteria, chest expansion and occiput-to-wall distance.
    • Spinal and sacroiliac joint inflammation as assessed by change from baseline in SPARCC MRI score of sacroiliac joints and spine.
    • Enthesitis, as assessed by change from baseline in MASES.
    • Quality of life, as assessed by change from baseline in FACIT-Fatigue, SF-36, and ASQoL scores.

    Safety:
    Incidence of AEs, SAEs, and discontinuations due to AEs, as well as changes in laboratory results, ECGs, physical examination and vital signs.
    Eficacia:
    • Signos y síntomas de la espondilitis anquilosante, determinado por:
    - cambio con respecto al inicio en la puntuación ASDAS;
    - porcentaje de pacientes que logran una respuesta ASAS20, ASAS40, ASAS 5/6 y una remisión parcial ASAS;
    - cambio con respecto al inicio en el recuento de 44 articulaciones;
    - proporciones de sujetos que presentan una mejoría clínicamente importante (disminución de ASDAS desde el inicio ≥1,1), una mejoría importante (disminución de ASDAS desde el inicio ≥2,0) y una enfermedad inactiva (ASDAS <1,3);
    - cambio con respecto al inicio en la puntuación ASDAS y en la respuesta a los componentes idividuales de los criterios ASAS;
    - porcentaje de sujetos que logran una respuesta BASDAI del 50 % (BASDAI50) y una mejora de ≥2 unidades en BASDAI (ΔBASDAI ≥2):
    - cambio con respecto al inicio en la puntuacíón BASDAI.
    • Función física, evaluada por el cambio con respecto al inicio en la puntuación BASFI.
    • Movilidad de la columna vertebral, evaluada por el cambio con respecto al inicio en BASMI lineal y en los componentes inidividuales de los criterios de BASMI, la expansión torácica y la distancia entre el occipucio y la pared.
    • Inflamación de las articulaciones vertebrales y sacroilíacas, evaluada por el cambio con respecto al inicio en la puntuación de la RM según SPARCC de las articulaciones vertebrales y sacroilíacas.
    • Entesitis, evaluada por el cambio con respecto al inicio en la puntuación MASES.
    • Calidad de vida, evaluada por el cambio con respecto al inicio en las puntuaciones FACIT-Fatiga, SF-36 y ASQoL.

    Seguridad:
    Incidencia de acontecimientos adversos (AA), acontecimientos adversos graves e interrupciones por AA, así como cambios en los resultados analíticos, electrocardiogramas (ECG), la exploración física y 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
    LVLS
    LVLS
    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 days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 90
    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 71
    F.4.2.2In the whole clinical trial 100
    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 vuelve al 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 Decision2017-02-01
    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
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