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    Summary
    EudraCT Number:2019-003229-12
    Sponsor's Protocol Code Number:M19-944
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-06
    Trial 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 number2019-003229-12
    A.3Full title of the trial
    A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis
    Programa de fase 3 aleatorizado, controlado con placebo y doble ciego para evaluar la eficacia y la seguridad de upadacitinib en pacientes adultos con espondiloartritis axial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of upadacitinib in adult subjects with axial spondyloarthritis
    Evaluación del upadacitinib en sujetos adultos con espondiloartritis axial
    A.4.1Sponsor's protocol code numberM19-944
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0044901200103
    B.5.6E-mailabbvie_reec@abbvie.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 nameUpadacitinib
    D.3.2Product code ABT-494
    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 INNUPADACITINIB
    D.3.9.1CAS number 1310726-60-3
    D.3.9.2Current sponsor codeABT-494
    D.3.9.4EV Substance CodeSUB187251
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 Yes
    D.3.11.13.1Other medicinal product typeJanus kinase (JAK) 1 inhibitor
    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 placeboTablet
    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
    Axial Spondyloarthritis
    Espondiloartritis axial
    E.1.1.1Medical condition in easily understood language
    Axial Spondyloarthritis
    Espondiloartritis axial
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10071400
    E.1.2Term Axial spondyloarthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076297
    E.1.2Term Non-radiographic axial spondyloarthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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
    • To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adult subjects with active axSpA including AS who had an inadequate response to a biologic disease-modifying antirheumatic drug (bDMARD) therapy (Study 1) and nr axSpA (Study 2);
    • To assess the safety and tolerability of upadacitinib in subjects with active axSpA including bDMARD-IR AS (Study 1) and with nr axSpA (Study 2).
    - Para evaluar la eficacia del upacitinib se comparará con placebo la reducción de signos y síntomas en sujetos adultos con axSpa incluyendo AS quien ha tenido una inadecuada respuesta a terapia biológica antirreumática modificadora de la enfermedad (bDMARD) (Estudio 1) y nr-axSpA (Estudio 2).
    - Evaluar la seguridad y tolerabilidad del upadacitinib en sujetos con axSpA activo, incluido bDMARD-IR AS (Estudio 1) y con nr-axSpA (Estudio 2).
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of upadacitinib in extended treatment in adult subjects with active axSpA including bDMARD-IR AS who have completed the Double Blind Period (Study 1) and with nr-axSpA who have completed the Double Blind Period (Study 2).
    - Para evaluar la seguridad y tolerabilidad a upacitinib en tratamiento prolongado en sujetos adultos con axSpA activo, incluyendo bDMARD-IR AS que han completado el Período Doble Ciego (Estudio 1) y con nr-axSpA que han completado el Período Doble Ciego (Estudio 2).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • adult females and males who are at least 18 years of age
    • clinical diagnosis of AS who meet the modified New York Criteria for AS (Study 1); OR
    • clinical diagnosis of nr-axSpA fulfilling the 2009 ASAS classification criteria for axSpA but not meeting the radiologic criterion of the modified New York criteria for AS and have objective signs of active inflammation on MRI of sacroiliac joints or based on high sensitivity CRP > ULN (Study 2).
    • must have a BASDAI score ≥ 4 and a Patient's Assessment of Total Back Pain score ≥ 4 based on a 0 – 10 numerical rating scale at the Screening and Baseline Visits.
    • For Study 1, subjects must have discontinued 1 bDMARD (either 1 tumor necrosis factor (TNF) inhibitor or 1 interleukin [IL]-17 inhibitor) due to either intolerance or lack of efficacy.
    • For Study 2, prior treatment with at most 1 bDMARD (either 1 TNF inhibitor or 1 IL-17 inhibitor) is allowed in at least 25%, but not exceeding 35% of subjects
    - Los adultos de ambos sexos que tengan al menos 18 años de edad
    - Diagnóstico clínico de EA que cumplen con los Criterios de Nueva York modificados para
    AS (Estudio 1); O
    - Diagnóstico clínico de nr-axSpA que cumple los criterios de clasificación ASAS 2009 para axSpA pero que no cumple el criterio radiológico de los criterios modificados de Nueva York para AS y tiene signos objetivos de inflamación activa en la IRM de las articulaciones sacroilíacas o basados en la CRP de alta sensibilidad > ULN (Estudio 2).
    - Debe tener un puntaje de BASDAI ≥ 4 y un puntaje de Evaluación del Dolor Total de Espalda del Paciente ≥ 4 basado en una escala numérica de calificación de 0 - 10 en las Visitas de Revisión y visita basal.
    - Para el Estudio 1, los sujetos deben haber descontinuado 1 bDMARD (ya sea 1 inhibidor del factor de necrosis tumoral (TNF) o 1 inhibidor de interleucina[IL]-17) debido a intolerancia o falta de eficacia.
    - Para el Estudio 2, se permite el tratamiento previo con un máximo de 1 bDMARD (1 inhibidor del TNF o 1 inhibidor de la IL-17) en al menos el 25%, pero sin exceder el 35% de los sujetos.
    E.4Principal exclusion criteria
    • Subject must not have total spinal ankylosis
    • Subjects who have had an inadequate response to both a TNF inhibitor and IL-17 inhibitor are not eligible.
    - Los sujetos no deben tener la médula espinal totalmente anquilosada
    - Los sujetos quienes hayan tenido una respuesta inadecuada a los inhibidores TNf y a los inhibidores del IL-17 no son elegibles.
    E.5 End points
    E.5.1Primary end point(s)
    Study 1 - proportion of subjects achieving an ASAS 40 response
    Study 2 - proportion of subjects achieving an ASAS 40 response
    Estudio 1- proporción de sujetos que han desarrollado una respuesta de 40 ASAS
    Estudio 2- proporción de sujetos que han desarrollado una respuesta de 40 ASAS
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study 1 - Week 14
    Study 2 - Week 14 (EU/EMA regulatory purposes); Week 52 (US/FDA regulatory purposes).
    Estudio 1 - Semana 14
    Estudio 2 - Semana 14 (Fines regulatorios de UE / EMA ); Semana 52 (Fines regulatorios de EE.UU/ FDA).
    E.5.2Secondary end point(s)
    Study 1:
    1. Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS);
    2. Change from Baseline in magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score (spine);
    3. Proportion of subjects with ASAS partial remission (PR) (an absolute score of ≤ 2 units for each of the 4 domains identified in ASAS 40);
    4. Proportion of subjects with Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response;
    5. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI);
    6. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL);
    7. Change from Baseline in ASAS Health Index (HI);
    8. Change from Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES);
    9. Change from Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMIlin).

    Study 2:
    1. Change from Baseline in ASDAS;
    2. Change from Baseline in MRI SPARCC score (SI joints);
    3. Proportion of subjects with BASDAI 50 response;
    4. Proportion of subjects with ASAS PR (an absolute score of ≤ 2 units for each of the 4 domains identified in ASAS 40);
    5. Change from Baseline in BASFI;
    6. Change from Baseline in ASQoL;
    7. Change from Baseline in ASAS HI;
    8. Change from Baseline in MASES;
    9. Change from Baseline in BASMIlin.
    Estudio 1.
    Cambio desde la visita basal en la puntuación de actividad de la espondilitis anquilosante
    (ASDAS);
    2. Cambio con respecto a la visita basal en imágenes por resonancia magnética (IRM)
    Puntaje del Spondyloarthritis Research Consortium of Canada (SPARCC) (columna vertebral);
    3. Proporción de sujetos con remisión parcial (RP) de la ASAS (en términos absolutos) de ≤ 2 unidades para cada uno de los 4 dominios identificados en ASAS 40);
    4. Proporción de sujetos con espondilitis anquilosante de baño Índice de actividad (BASDAI) 50 respuestas;
    5. Cambio desde la visita basal en el índice funcional de la espondilitis anquilosante en el Índice funcional de la espondilitis anquilosante de baño (BASFI);
    6. Cambio desde la visita basal en la calidad de vida de la espondilitis anquilosante
    (ASQoL);
    7. Variación con respecto a la visita basal del Índice de Salud ASAS (HI);
    8. Cambio con respecto a la visita basal en la entesitis por espondilitis anquilosante de Maastricht Puntuación (MASES);
    9. Cambio desde la visita basal en la metrología de la espondilitis anquilosante en baño lineal
    Índice (BASMIlin).

    Estudio 2.
    1. Cambio desde la visita basal en ASDAS;
    2. Cambio desde la visita basal en la puntuación de MRI SPARCC (articulaciones SI);
    3. Proporción de sujetos con respuesta BASDAI 50;
    4. Proporción de sujetos con ASAS PR (una puntuación absoluta de ≤ 2 unidades para cada uno de los 4 dominios identificados en ASAS 40);
    5. Cambio desde la visita basal en BASFI;
    6. Cambio desde la visita basal en ASQoL;
    7. Cambio desde la visita basal en ASAS HI;
    8. Cambio desde la visita basal en MASES;
    9. Cambio desde la visita basal en BASMIlin.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Study 1 and Study 2 - Week 14
    Estudio 1 y Estudio 2 - Semana 14
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA92
    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
    Brazil
    Canada
    China
    Japan
    Korea, Republic of
    Mexico
    New Zealand
    Russian Federation
    Taiwan
    Turkey
    Ukraine
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    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: 630
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 690
    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)
    Subjects will be expected to go on standard of care after study completion.
    Se espera que los sujetos continúen con el mismo nivel de cuidado después de terminar sus estudios.
    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 Decision2020-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-14
    P. End of Trial
    P.End of Trial StatusOngoing
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