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    Summary
    EudraCT Number:2019-003229-12
    Sponsor's Protocol Code Number:M19-944
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 ConcernedItaly - Italian Medicines Agency
    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
    Programma di Fase 3, randomizzato, in doppio cieco, controllato verso placebo per valutare l’efficacia e la sicurezza di upadacitinib in soggetti adulti affetti da spondiloartrite assiale
    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
    Valutazione di upadacitinib in soggetti adulti affetti da spondiloartrite assiale
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    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 number00441628561090
    B.5.5Fax number00441628461153
    B.5.6E-maileu-clinical-trials@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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Spondiloartrite assiale
    E.1.1.1Medical condition in easily understood language
    Axial Spondyloarthritis
    Spondiloartrite assiale
    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 diseasemodifying
    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).
    - Valutare l’efficacia di upadacitinib rispetto a placebo per quanto riguarda la riduzione di segni e sintomi in soggetti adulti affetti da SpA assiale in fase attiva, compresi soggetti con SA che hanno avuto una risposta inadeguata alla terapia con un farmaco antireumatico modificante la malattia biologico (bDMARD) (Studio 1) e soggetti con SpA assiale nr (Studio 2);
    - Valutare la sicurezza e la tollerabilità di upadacitinib in soggetti adulti affetti da SpA assiale in fase attiva, compresi soggetti bDMARD-IR con SA (Studio 1) e i soggetti affetti da SpA assiale nr (Studio 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 nraxSpA
    who have completed the Double Blind Period (Study 2).
    - Valutare la sicurezza e la tollerabilità di upadacitinib nell’ambito di un’estensione del trattamento in soggetti adulti affetti da SpA assiale in fase attiva, compresi soggetti bDMARD-IR con SA che hanno completato il Periodo in doppio cieco (Studio 1) e soggetti con SpA assiale nr che hanno completato il Periodo in doppio cieco (Studio 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
    XML File Identifier: G/7hfzyKVO6sW7dx2QMYVvhMt0Q=
    Page 11/22
    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
    • Soggetti adulti di ambo i sessi, di età pari o superiore a 18 anni
    • Soggetti con diagnosi clinica di SA, che soddisfano i criteri modificati di New York per SA (Studio 1); OPPURE
    • Soggetti con diagnosi clinica di SpA assiale nr che soddisfano i criteri di classificazione ASA 2009 per SpA assiale senza tuttavia soddisfare il criterio radiologico per SA indicato dai criteri modificati di New York e che presentano segni oggettivi di infiammazione in fase attiva delle articolazioni sacroiliache alla risonanza magnetica oppure sulla base di livelli di PCR ad alta sensibilità > ULN (Studio 2)
    • Soggetti con punteggio BASDAI = 4 e un punteggio relativo alla valutazione da parte del paziente del dolore totale alla schiena = 4 sulla base di una scala di valutazione numerica con punti compresi fra 0 e 10, alla visita di Screening e alla visita di Baseline.
    • Per lo Studio 1, i soggetti devono aver interrotto 1 bDMARD (un inibitore del fattore di necrosi tumorale [TNF] oppure un inibitore dell’interleuchina [IL]-17) per intolleranza o per mancanza di efficacia.
    • Per lo Studio 2 è permesso il trattamento pregresso con un massimo di un bDMARD (un inibitore del TNF oppure un inibitore di IL-17) in almeno il 25% ma non oltre il 35% dei soggetti
    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.
    • Il soggetto non deve presentare anchilosi completa del rachide
    • Non sono eleggibili soggetti che hanno avuto una risposta inadeguata sia a un inibitore del TNF che a un inibitore di IL-17
    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
    Studio 1 - percentuale di soggetti che ottengono la risposta ASAS 40
    Studio 2 - percentuale di soggetti che ottengono la risposta ASAS 40
    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).
    Studio 1 - Settimana 14
    Studio 2 - Settimana 14 (finalità regolatorie UE/EMA); Settimana 52 (finalità regolatorie USA/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;
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    Page 12/22
    7. Change from Baseline in ASAS HI;
    8. Change from Baseline in MASES;
    9. Change from Baseline in BASMIlin.
    Studio 1:
    1. Variazione rispetto al Baseline del punteggio ASDAS (Ankylosing Spondylitis Disease Activity Score);
    2. Variazione rispetto al Baseline del punteggio MRI SPARCC (Spondyloarthritis Research Consortium of Canada) alla risonanza magnetica (RM) (rachide);
    3. Percentuale di soggetti con remissione parziale (RP) in base al punteggio ASAS (punteggio assoluto pari a = 2 unità per ciascuno dei 4 domini identificati nel parametro ASAS 40);
    4. Percentuale di soggetti con risposta BASDAI (Baath Ankylosing Spondylitis Disease Activity Index) 50;
    5. Variazione rispetto al Baseline del punteggio BASFI (Bath Ankylosing Spondylitis FUnctional Index);
    6. Variazione rispetto al Baseline del punteggio ASQoL (Ankylosing Spondylitis Quality of Life;
    7. Variazione rispetto al Baseline del punteggio ASAS HI (Health Index);
    8. Variazione rispetto al Baseline del punteggio MASES (Maastricht Ankylosing Spondylitis Enthesitis Score;
    9. Variazione rispetto al Baseline del punteggio BASMIlin (Linear Batrh Ankylosing Spondylitis Metrology Index)

    Studio 2:
    1. Variazione rispetto al Baseline del punteggio ASDAS;
    2. Variazione rispetto al Baseline del punteggio MRI SPARCC (articolazioni sacro-iliache)
    3. Percentuale di soggetti con risposta BASDAI 50;
    4. Percentuale di soggetti con RP sulla base del parametro ASAS (punteggio assoluto pari a = 2 unità per ciascuno dei 4 domini identificati nel parametro ASAS 40);
    5. Variazione rispetto al Baseline del punteggio BASFI;
    6. Variazione rispetto al Baseline del punteggio ASQoL;
    7. Variazione rispetto al Baseline del punteggio ASAS HI;
    8. Variazione rispetto al Baseline del punteggio MASES;
    9. Variazione rispetto al Baseline del punteggio BASMIlin.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Study 1 and Study 2 - Week 14
    Studio 1 e Studio 2 – Settimana 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 concerned5
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    China
    Japan
    Korea, Republic of
    Mexico
    New Zealand
    Russian Federation
    Taiwan
    Ukraine
    United States
    Argentina
    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 months4
    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 months1
    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: 59
    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 state15
    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.
    Una volta che i soggetti abbiano completato lo studio, è prevista la ripresa dello standard di cura
    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 Decision2020-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-09
    P. End of Trial
    P.End of Trial StatusCompleted
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