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    Summary
    EudraCT Number:2021-000465-32
    Sponsor's Protocol Code Number:CNTO1959PSA4002
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-12-03
    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 number2021-000465-32
    A.3Full title of the trial
    A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Bio-naive Participants with Active Psoriatic Arthritis Axial Disease
    Studio di fase 4, multicentrico, randomizzato, in doppio cieco, controllato con placebo per valutare l’efficacia e la sicurezza di Guselkumab somministrato per via sottocutanea in soggetti bio-naive con artrite psoriasica assiale attiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Guselkumab versus Placebo for the Treatment of Psoriatic Arthritis Axial Disease in Bio-naive Participants
    Guselkumab in confronto al placebo per il trattamento dell'artrite psoriasica assiale in soggetti che non hanno mai ricevuto farmaci biologici
    A.3.2Name or abbreviated title of the trial where available
    STAR
    STAR
    A.4.1Sponsor's protocol code numberCNTO1959PSA4002
    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 SponsorJANSSEN CILAG INTERNATIONAL 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 supportJanssen Pharmaceutica, N.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Biologics B.V.
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031715242166
    B.5.5Fax number0031715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 nameGuselkumab
    D.3.2Product code [CNTO1959]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGuselkumab
    D.3.9.2Current sponsor codeCNTO1959
    D.3.9.3Other descriptive nameD.3.6.2 - valore: 100 q8w or q4w mg milligram(s)
    D.3.9.4EV Substance CodeSUB179789
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    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 typeMonoclonal antibody
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Psoriatic Arthritis Axial Disease
    Artrite psoriasica assiale attiva
    E.1.1.1Medical condition in easily understood language
    Psoriasis Arthritis
    Artrite psoriasica
    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 21.0
    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 efficacy of guselkumab treatment in participants with active PsA axial disease by assessing reduction in axial symptoms.
    Valutare l’efficacia del trattamento con guselkumab nei soggetti con artrite psoriasica assiale attiva tramite valutazione della riduzione dei sintomi assiali.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of guselkumab on additional measures of axial symptoms, reduction in axial inflammation, and other signs and symptoms of PsA, psoriasis, and participant well-being.
    - To evaluate the safety of guselkumab in participants with active PsA.
    - To evaluate the pharmacokinetics and immunogenicity of guselkumab in participants with active PsA.
    - Valutare l’efficacia di guselkumab su ulteriori misurazioni dei sintomi assiali, riduzione dell’infiammazione assiale e altri segni e sintomi di artrite psoriasica, psoriasi e sul benessere dei soggetti inclusi nello studio.
    - Valutare la sicurezza di guselkumab in soggetti con artrite psoriasica attiva.
    - Valutare la farmacocinetica (PK) e l’immunogenicità di guselkumab in soggetti con artrite psoriasica attiva.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Initial Clinical Protocol, 14 April 2021, version 1.0. An MRI of hands/feet may be collected from participants at certain sites who consent to this optional substudy component of the study.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Protocollo clinico iniziale, 14 aprile 2021, versione 1.0. Una risonanza magnetica delle mani/piedi potrà essere effettuata dai partecipanti in determinati centri che acconsentiranno a partecipare al sottostudio, parte facoltativa dello studio.
    E.3Principal inclusion criteria
    - Be at least 18 years of age.
    - Have a diagnosis of PsA for at least 6 months prior to the first administration of study intervention and meet ClASsification criteria for Psoriatic ARthritis criteria at screening.
    - Have active PsA as defined by: At least 3 swollen joints and at least 3 tender joints at screening and at baseline and C-reactive protein >=0.3 mg/dL at screening from the central laboratory.
    - Have a BASDAI score of at least 4.
    - Have magnetic resonance imaging-confirmed PsA axial disease (positive MRI spine and/or SI joints, shown by a SPARCC score of >=3 in either the spine or the sacroiliac joints).
    - Have a spinal pain score of at least 4.

    For the complete overview of the inclusion criteria, please refer to section 5.1 of the protocol
    - Età >= 18 anni (o l’età legale del consenso nella giurisdizione in cui si svolge lo studio).
    - Diagnosi di PsA da almeno 6 mesi prima della prima somministrazione del trattamento dello studio e soddisfare i Criteri di classificazione per l’artrite psoriasica (ClASsification criteria for Psoriatic ARthritis, CASPAR) allo screening.
    - Avere una PsA attiva definita dalla presenza di: almeno 3 articolazioni gonfie e almeno 3 articolazioni dolenti allo screening e al basale e un valore di Proteina C-reattiva (C-reactive protein, CRP) >=0,3 mg/dl allo screening.
    - Avere un punteggio BASDAI di almeno 4.
    - Avere una PsA assiale confermata dalla risonanza magnetica per immagini (RMI della colonna vertebrale e/o delle articolazioni SI positiva, dimostrata da un punteggio SPARCC di >=3 nella colonna vertebrale o nelle articolazioni sacroiliache)
    - Avere un punteggio di dolore vertebrale di almeno 4.

    Per una lista completa dei criteri di inclusione, fare riferimento alla sezione 5.1 del protocollo
    E.4Principal exclusion criteria
    - Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis, ankylosing spondylitis/non-radiographic-axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease.
    - Has previously received any biologic treatment including, but not limited to, guselkumab, ustekinumab, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab or other investigative biologic treatment.
    - Has ever received a Janus kinase inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor.
    - Has received any systemic immunosuppressants within 4 weeks of the first administration of study intervention.
    - Has received apremilast within 4 weeks prior to the first administration of study intervention.
    - Has received non-biologic DMARDs other than MTX, SSZ, HCQ, LEF, within 4 weeks before the first administration of study intervention.

    For the complete overview of the exclusion criteria, please refer to section 5.2 of the protocol
    - Ha altre malattie infiammatorie che potrebbero confondere le valutazioni del beneficio della terapia con guselkumab, inclusi, a titolo esemplificativo ma non esaustivo, l’artrite reumatoide (AR), spondilite anchilosante (SA)/spondiloartrite non radiografica-assiale (questa non include una diagnosi primaria di PsA con spondilite), lupus eritematoso sistemico, o malattia di Lyme (confermata da Western blot).
    - Ha assunto in precedenza qualsiasi trattamento con agenti biologici inclusi, a titolo esemplificativo ma non esaustivo, guselkumab, ustekinumab, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab o altro trattamento con agenti biologici sperimentali.
    - Ha assunto in qualsiasi momento un inibitore della Janus kinasi (JAK) inclusi, a titolo esemplificativo ma non esaustivo, tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib o qualsiasi altro inibitore di JAK sperimentale.
    - Ha assunto qualsiasi immunosoppressore sistemico (es. azatioprina, ciclosporina, tioguanina 6, mercaptopurina, micofenolato mofetile, idrossiurea, tacrolimus) nelle 4 settimane precedenti la prima della somministrazione del trattamento dello studio.
    - Ha assunto apremilast nelle 4 settimane precedenti la prima somministrazione del trattamento dello studio.
    - Ha assunto DMARD non biologici diversi da MTX, SSZ, HCQ, LEF, nelle 4 settimane precedenti la prima somministrazione del trattamento dello studio.

    Per una lista completa dei criteri di esclusione, fare riferimento alla sezione 5.2 del protocollo
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in BASDAI at Week 24.
    Variazione rispetto al basale in BASDAI alla Settimana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Settimana 24
    E.5.2Secondary end point(s)
    - Change from baseline in ASDAS-CRP at Week 24
    - Change from baseline in Disease Activity Index for Psoriatic Arthritis at Week 24
    - Change from baseline in Health Assessment Questionnaire – Disability Index at Week 24
    - Proportion of participants with investigator's global assessment 0/1 response at Week 24 among the participants with >=3% BSA psoriatic involvement and an IGA score of >=2 at baseline.
    - Change from baseline in Spondyloarthritis Research Consortium of Canada score for MRI sacroiliac joints at Week 24
    - Proportion of participants who achieve a >=50% improvement from baseline in BASDAI score at Week 24
    - Proportion of participants who achieve ASDAS clinically important improvement at Week 24
    - Proportion of participants who achieve ASAS 40 response at Week 24
    - Proportion of participants who achieve ASDAS major improvement at Week 24
    - Change from baseline in SPARCC score for MRI spine at Week 24
    - Variazione rispetto al basale in ASDAS-CRP alla Settimana 24
    - Variazione rispetto al basale dell’indice di attività della malattia per l’artrite psoriasica (Disease Activity Index for Psoriatic Arthritis, DAPSA) alla settimana 24
    - Variazione rispetto al basale nel questionario di valutazione della salute – Indice di disabilità (Health Assessment Questionnaire – Disability Index, HAQ-DI) alla settimana 24
    - Percentuale di soggetticon risposta 0/1 alla valutazione globale dello sperimentatore (IGA) alla settimana 24 tra i soggetti con coinvolgimento psoriasico della superficie corporea >=3% e un punteggio IGA >=2 (lieve) al basale
    - Variazione rispetto al basale nel punteggio del Consorzio di ricerca sulla spondiloartrite del Canada (Spondyloarthritis Research Consortium of Canada, SPARCC) per la risonanza magnetica delle articolazioni sacroiliache alla settimana 24 (tra i soggetti con una risonanza magnetica positiva delle articolazioni sacroiliache al basale)
    - Percentuale di soggetti che ottengono un miglioramento >=50% rispetto al basale nel punteggio BASDAI alla Settimana 24
    - Percentuale di soggetti che raggiungono un miglioramento clinicamente importante dell'ASDAS alla settimana 24
    - Percentuale di soggetti che raggiungono la risposta ASAS 40 alla settimana 24
    - Percentuale di soggetti che ottengono un miglioramento importante dell'ASDAS alla settimana 24
    - Variazione rispetto al basale nel punteggio SPARCC per la risonanza magnetica della colonna vertebrale alla settimana 24 (tra i soggetti con una risonanza magnetica della colonna vertebrale positiva al basale)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24
    Settimana 24
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity and Biomarker assessments
    Immunogenicità e valutazioni dei biomarcatori
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    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 trial3
    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 EEA95
    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
    Hong Kong
    Puerto Rico
    Turkey
    Bulgaria
    Czechia
    Denmark
    Germany
    Hungary
    Israel
    Italy
    Malaysia
    Poland
    Portugal
    Russian Federation
    Spain
    Taiwan
    Ukraine
    United Kingdom
    United States
    France
    E.8.7Trial has a data monitoring committee No
    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 years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 365
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 405
    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)
    Participants will be instructed that study intervention will not be made available to them after they have completed/discontinued study intervention and that they should return to their primary physician to determine standard of care.
    Local regulations on continued access will always take precedence. Plans for continued access stated in this protocol may change if new information on the benefit-risk profile of guselkumab becomes available during the study or program.
    Ai soggetti verrà comunicato che il farmaco di studio non sarà reso loro disponibile dopo aver completato/interrotto lo studio e che dovranno tornare dal proprio medico di base per determinare lo standard di cura.
    Le normative locali sull'accesso continuato avranno sempre la precedenza. I piani per l'accesso continuato indicati in questo protocollo possono cambiare se nuove informazioni sul profilo beneficio-rischio di guselkumab diventano disponibili durante lo studio o il programma.
    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 Decision2022-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-22
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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