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    Summary
    EudraCT Number:2020-005097-10
    Sponsor's Protocol Code Number:IM011-054
    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:2021-07-27
    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 number2020-005097-10
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Psoriatic Arthritis who are Naïve to Biologic Disease-modifying Antirheumatic Drugs
    Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo per valutare l’efficacia e la sicurezza di deucravacitinib in partecipanti con artrite psoriasica attiva, naïve ai farmaci antireumatici biologici modificanti la malattia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Deucravacitinib Compared with Placebo in Participants with Active Psoriatic Arthritis (PsA) who are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs
    Efficacia e sicurezza di deucravacitinib rispetto al placebo in partecipanti con artrite psoriasica (AP) attiva, naïve ai farmaci antireumatici biologici modificanti la malattia.
    A.3.2Name or abbreviated title of the trial where available
    POETYK PsA-1
    POETYK PsA-1
    A.4.1Sponsor's protocol code numberIM011-054
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1259-9443
    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 SponsorBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointGSM-CT
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.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 nameDEUCRAVACITINIB
    D.3.2Product code [BMS-986165]
    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 INNdeucravacitinib
    D.3.9.1CAS number 1609392-27-9
    D.3.9.2Current sponsor codeBMS-986165
    D.3.9.4EV Substance CodeSUB180283
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 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
    Active Psoriatic Arthritis
    Artrite Psoriasica Attiva
    E.1.1.1Medical condition in easily understood language
    Active Psoriatic Arthritis
    Artrite Psoriasica Attiva
    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 compare the efficacy of deucravacitinib to placebo in the treatment of participants with active PsA
    Confrontare l’efficacia di deucravacitinib rispetto al placebo nel trattamento di partecipanti con AP attiva
    E.2.2Secondary objectives of the trial
    To compare the efficacy of deucravacitinib to placebo at Week 16:
    - as assessed by DAS28-CRP
    - as assessed by HAQ-DI
    - as assessed by PASI 75 response
    - as assessed by SF-36 PCS score
    - in enthesitis resolution
    - in MDA response
    - in FACIT-Fatigue
    - in dactylitis resolution
    - as assessed by structural damage
    Confrontare l’efficacia di deucravacitinib rispetto al placebo alla settimana 16:
    -mediante DAS28-CRP
    -secondo il questionario HAQ-DI
    -secondo la risposta del PASI 75
    -secondo il punteggio SF-36 PCS
    -nella risoluzione dell’entesite
    -nella risposta MDA
    -nel FACIT-Fatigue
    -nella risoluzione della dattilite
    -secondo il danno strutturale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participant has been diagnosed to have PsA (by any criteria) of at least
    3 months duration at Screening.
    - Participant meets the CASPAR criteria at Screening.
    - Participant has active plaque psoriatic skin lesion(s) or documented medical history of plaque PsO at Screening.
    - Participant has active arthritis as shown by = 3 swollen joints and = 3 tender joints (66/68 joint counts) at Screening and Day 1.
    - Participant has = 1 PsA-related hand and/or foot joint erosion on X-ray during Screening period that is confirmed by central reading.
    - Participant has hsCRP = 3 mg/L at Screening.
    - Participant has had documented inadequate response, loss of response or intolerance to at least 1 of the following:
    • A csDMARD at maximally tolerated dose, and/or apremilast, after a minimum of 12 weeks duration of therapy given for the treatment of PsA
    • An NSAID after a minimum of 4 weeks duration of therapy given for the treatment of PsA, or participant has intolerance to those treatments
    in the opinion of the investigator
    -Al partecipante è stata diagnosticata l’AP (secondo qualsiasi criterio) da un periodo di almeno 3 mesi al momento dello screening.

    - Il partecipante soddisfa i criteri CASPAR allo screening.
    - Il partecipante presenta lesioni cutanee psoriasiche a placche attive o anamnesi documentata di PsO a placche allo screening.
    - Il partecipante presenta artrite attiva, dimostrata da un numero = 3 di articolazioni tumefatte e da un numero = 3 di articolazioni dolenti (66/68 conte articolari) allo screening e al Giorno 1.
    - Il partecipante presenta = 1 erosione della mano e/o dell’articolazione del piede correlata all’AP alla radiografia durante il periodo di screening, confermata da lettura centrale.
    - Il partecipante presenta hsCRP = 3 mg/l allo screening.
    - Il partecipante ha presentato risposta inadeguata, perdita di risposta o intolleranza documentata ad almeno 1 dei seguenti:
    ¿ Un csDMARD alla dose massima tollerata e/o apremilast dopo un minimo di 12 settimane di terapia, somministrato per il trattamento dell’AP.
    ¿ Un FANS dopo un minimo di 4 settimane di terapia somministrata per il trattamento dell’AP, oppure il partecipante presenta intolleranza a tali trattamenti secondo il parere dello sperimentatore.
    E.4Principal exclusion criteria
    - Participant has non-plaque PsO (ie, guttate, pustular, erythrodermic or drug-induced PsO) at Screening or Day 1.
    - Participant has any other autoimmune condition such as, systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis.
    - Participant has prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
    - Participant has active (ie, currently symptomatic) fibromyalgia whose symptoms or therapy will significantly impact the assessment of PsA disease manifestations and activity in the opinion of the investigator.
    - Participant has received an approved or investigational biologic therapy for the treatment of PsA or PsO.
    -Il partecipante presenta PsO non a placche (ovvero PsO guttata, pustolosa, eritrodermica o indotta da farmaci) allo screening o al Giorno 1.
    - Il partecipante presenta qualsiasi altra patologia autoimmune come lupus eritematoso sistemico, malattia mista del tessuto connettivo, sclerosi multipla o vasculite.
    - Il partecipante presenta un’anamnesi pregressa o attuale di malattia infiammatoria articolare diversa dall’AP (ad es. gotta, artrite reattiva, artrite reumatoide, spondilite anchilosante, malattia di Lyme).
    - Il partecipante presenta fibromialgia attiva (ovvero attualmente sintomatica) i cui sintomi o la cui terapia influiranno significativamente sulla valutazione delle manifestazioni della malattia e dell’attività dell’AP secondo il parere dello sperimentatore.
    - Il partecipante ha ricevuto una terapia biologica approvata o sperimentale per il trattamento dell’AP o della PsO.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants meeting ACR 20 response
    Percentuale di partecipanti che soddisfano la risposta ACR 20
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 16
    alla Settimana 16
    E.5.2Secondary end point(s)
    1- Change from baseline in DAS28-CRP score
    1- Change from baseline in HAQ-DI score
    1- Proportion of participants meeting PASI 75 response
    1- Change from baseline in the SF-36 PCS
    1- Proportion of participants meeting enthesitis resolution
    1- Proportion of participants meeting achievement of MDA
    1- Change from baseline in FACIT-Fatigue
    1- Proportion of participants meeting dactylitis resolution
    1- Change from baseline in PsA-modified SvdH score
    Additional Secondary Endpoints
    2- Proportion of participants meeting ACR 20, ACR 50, and ACR 70
    response
    2- Change from baseline in HAQ-DI score
    2- Proportion of participants who achieve a clinically meaningful
    improvement in HAQ-DI score
    2- Proportion of participants with achievement of PASI 75/90/100
    response
    2- Change from baseline in the SF-36 PCS score
    2- Proportion of participants meeting enthesitis resolution
    2- Proportion of participants meeting achievement of MDA
    2- Change from baseline in SF-36 Score MCS
    2- Change from baseline in FACIT-Fatigue
    2- Proportion of participants meeting dactylitis resolution
    2- Change from baseline in PsAID 12
    2- Change from baseline in DAPSA score
    2- Proportion of participants meeting achievement of PGA-F of 0/1
    2- Change from baseline in DAS28-CRP score
    2- Change from baseline in PASDAS
    2- Change from baseline in mCPDAI score
    2- Proportion of participants achieving PsARC response
    2- Proportion of participants meeting achievement of improvement from baseline in BASDAI score
    1- Proportion of participants meeting achievement of total PsA-modified SvdH score of = 0, = 0.5, and = SDC
    1- Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of = 0, = 0.5, and = SDC
    1- Proportion of participants meeting achievement of PsA-modified SvdH JSN score change of = 0, = 0.5, and = SDC
    1- Change in PsA-modified SvdH erosion score from baseline
    1- Change in PsA-modified SvdH JSN score
    2- Change from baseline in domain scales scores, PCS, and MCS of SF-36
    2- Change from baseline in the subcomponents of the WPAI questionnaire
    2- Change from baseline in the 5-level EQ-5D utility scores and its subcomponents
    2- Change from baseline in PROMIS sleep disturbance (short form)
    1-Variazione dal basale del punteggio DAS28-CRP
    1-Variazione dal basale del punteggio HAQ-DI
    1-Percentuale di partecipanti che ottengono una risposta PASI 75
    1-Variazione rispetto al basale nel punteggio PCS SF-36
    1-Percentuale di partecipanti che soddisfano la risoluzione dell’entesite
    1-Percentuale di partecipanti che soddisfano il raggiungimento dell’MDA
    1-Variazione rispetto al basale nel punteggio FACIT- Fatigue
    1-Percentualedi partecipanti che soddisfano la risoluzione della dattilite
    1-Variazione dal basale del punteggio di Sharp modificato per l’AP
    Ulteriori endopoint secondari
    2- Percentuali di partecipanti che soddisfano la risposta ACR 20, ACR 50, e ACR 70
    2- Variazione dal basale del punteggio HAQ-DI
    2- Percentuale di partecipanti che ha raggiunto un miglioramento clinicamente significativo nel punteggio HAQ-DI
    2- Percentuale di partecipanti che ottengono una risposta PASI 75/90/100
    2- Variazione dal basale del punteggio PCS SF-36
    2- Percentuale di partecipanti che soddisfano la risoluzione dell’entesite
    2- Percentuali di partecipanti che soddisfano il raggiungimento dell’ MDA
    2- Variazione dal basale del punteggio MCS SF-36
    2- Variazione dal basale nel punteggio FACIT-Fatigue
    2- Percentuale di partecipanti che soddisfano la risoluzione della dattilite
    2- Variazione dal basale nel punteggio PsAID 12
    2- Variazione dal basale nel punteggio DAPSA
    2- Proporzione di partecipanti che soddisfano il raggiungimento del PGA-F of 0/1
    2- Variazione dal basale del punteggio DAS28-CRP
    2- Variazione dal basale del punteggio PASDAS
    2- Variazionde dal basale del punteggio mCPDAI
    2- Percentuale di partecipanti che ottengono una risposta PsARC
    2- Percentuale di partecipanti che ha raggiunto un miglioramento dal basale nel punteggio BASDAI
    1-Percentuale di partecipanti che ottengono il punteggio totale di SvdH modificato per l’AP = 0, = 0.5, e = SDC
    1- Percentuale di partecipanti che ottengono una variazione del punteggio di erosione dell’ SvdH modificato per l’AP = 0, = 0.5, e = SDC
    1- Percentuale di partecipanti che ottengono una variazione del punteggio JSN del SvdH modificato per l’AP
    = 0, = 0.5, e = SDC
    1- Variazione del punteggio di erosione dal basale del SvdH modificato per l’AP
    2- Variazione del punteggio JSN del SdvH modificato per AP
    2- Variazione dal basale dei punteggi del dominio delle scale, PCS e MCS di SF-36
    2- Variazione dal basale nelle subcomponenti del questionario WPAI
    2- Variazione dal basale del punteggio di utilità del 5-level EQ-5D e dei suoi sottocomponenti
    2- Variazione dal basale del punteggio PROMIS sleep disturbance (modulo breve)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- At Week 16
    2- At Each Time Point up to Week 16
    1- Alla settimana 16
    2- Ad ogni time point fino alla Settimana 16
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA67
    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
    Brazil
    Chile
    China
    Colombia
    Mexico
    Russian Federation
    Taiwan
    Finland
    France
    Germany
    Hungary
    Ireland
    Italy
    Poland
    Romania
    Spain
    United Kingdom
    Czechia
    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
    Ultima visita dell’ultimo paziente ( LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days4
    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: 1092
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 208
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 740
    F.4.2.2In the whole clinical trial 1300
    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 completing 52 weeks of treatment in this study may be offered the opportunity to continue treatment with deucravacitinib in a long-term extension or a separate follow-up study.
    Ai partecipanti che completano le 52 settimane di trattamento in questo studio potrebbe essere offerta l’opportunità di continuare il trattamento con deucravacitinib nell’ambito di uno studio di estensione a lungo termine o di uno studio di follow-up separato.
    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 Decision2021-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-08
    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
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