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    Summary
    EudraCT Number:2019-000638-20
    Sponsor's Protocol Code Number:M19-130
    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:2021-06-17
    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 number2019-000638-20
    A.3Full title of the trial
    A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus
    Studio clinico di Fase 2 per valutare la sicurezza e l’efficacia di Elsubrutinib e Upadacitinib somministrati da soli oppure in combinazione (combinazione ABBV-599) in soggetti affetti da Lupus Eritematoso Sistemico in fase attiva e di grado da moderato a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus
    Studio clinico multicentrico, randomizzato, in doppio cieco, controllato verso placebo per valutare l’efficacia e la sicurezza di Elsubrutinib e Upadacitinib somministratI da soli oppure in combinazione (combinazione ABBV-599) in soggetti affetti da Lupus Eritematoso Sistemico in fase attiva e di grado da moderato a grave
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberM19-130
    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, Vanwell Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628561090
    B.5.5Fax number+441628461153
    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 nameElsubrutinib
    D.3.2Product code [ABBV-105]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNElsubrutinib
    D.3.9.1CAS number 1643570-24-4
    D.3.9.2Current sponsor codeABBV-105
    D.3.9.4EV Substance CodeSUB192702
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 2
    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 2050057-56-0
    D.3.9.2Current sponsor codeABT-494
    D.3.9.3Other descriptive nameABT-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 No
    D.IMP: 3
    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 2050057-56-0
    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 number30
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    Systemic Lupus Erythematosus (SLE)
    Lupus Eritematoso Sistemico (LES)
    E.1.1.1Medical condition in easily understood language
    SLE is a chronic disease where the body's immune system may attack the body's own skin, joints, kidneys, brain, and/or other organs. Women and people of African descent are more often affected.
    Lupus Eritematoso Sistemico LES malattia cronica per cui il sistema immunitario può attaccare pelle articolazioni reni cervello e/o altri organi. Sono colpite maggiormente donne e persone africane
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    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
    The main objective of this study is to evaluate the safety and efficacy of elsubrutinib, upadacitinib and ABBV-599 (elsubrutinib/upadacitinib) combination vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) at 24 and 48 weeks in subjects with moderately to severely active SLE and to define optimal dose(s) for further development.
    L’obiettivo principale di questo studio clinico è quello di valutare la sicurezza e l’efficacia di Elsubrutinib, upadacitinib e ABBV-599 combinazione (elsubrutinib/upadacitinib) rispetto a placebo per il trattamento dei segni e sintomi di Lupus Eritematoso Sistemico LES a 24 e 48 settimane in soggetti affetti da LES in fase attiva e di grado da moderato a grave, e determinare la/e dose/i ottimale/i per l’ulteriore sviluppo.
    E.2.2Secondary objectives of the trial
    na
    na
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adult male or female, 18 to 65 years of age, inclusive, at Screening.
    •Clinical diagnosis of SLE at least 24 weeks prior to Screening, meeting
    at least 4 of the 11 ACR criteria OR meeting at least 4 of the SLICC
    criteria including at least 1 clinical and 1 immunologic criterion.
    • At Screening, must have at least one of the following:
    · ANA+ (titer = 1:80)
    · anti-dsDNA+
    · anti-Smith+
    • SLEDAI-2K = 6 despite background therapy as reported and
    independently adjudicated (clinical score = 4, excluding lupus headache
    and/or organic brain syndrome) at Screening:
    · If 4 points of the required entry points are for arthritis there must also
    be a minimum of 3 tender and 3 swollen joints
    · If subject has rash and PI considers it to be attributable to SLE,
    subject must consent to skin photograph collection for adjudication.
    · Score must be re-confirmed at the Baseline Visit
    •The subject must be on background treatment throughout the study.
    The background treatment must be stable for 30 days prior to Baseline
    and throughout the study with:
    · Antimalarial(s), prednisone (or prednisone-equivalent) (= 20 mg),
    azathioprine (= 150 mg), mycophenolate (= 2 g), leflunomide (= 20
    mg), cyclosporine, tacrolimus, and/or MTX
    (= 20 mg).
    · The combination of background treatment with antimalarial(s) and/or
    prednisone (or equivalent) is permitted.
    · And a single, but not multiple, additional immunosuppressant from the
    list above, is permitted.
    • Soggetti adulti di ambo i sessi, di età compresa fra 18 e 65 anni inclusi allo Screening.
    • Diagnosi clinica del LES almeno 24 settimane prima dello screening, incontro
    almeno 4 degli 11 criteri ACR O che soddisfano almeno 4 dei criteri SLICC
    criteri che includono almeno 1 criterio clinico e 1 criterio immunologico.
    • Soggetti che allo Screening presentano almeno uno dei seguenti parametri:
    • ANA+ (titolo = 1:80)
    • anti-dsDNA+
    • anti-Smith+
    • Punteggio SLEDAI-2K = 6 nonostante la terapia di background, secondo quanto segnalato e aggiudicato in maniera indipendente (escluso il mal di testa secondario a lupus e/o sindrome cerebrale organica) (punteggio clinico = 4) allo Screening. Nel caso in cui 4 dei punti richiesti per l’ingresso nello studio si riferiscano all’artrite, è inoltre necessaria la presenza di un minimo di 3 articolazioni dolorabili alla palpazione e 3 articolazioni tumefatte.
    • Se il soggetto ha un'eruzione cutanea e PI ritiene che sia attribuibile al LES,
    Il soggetto deve acconsentire alla raccolta di fotografie di pelle per l'aggiudicazione.
    - Il punteggio deve essere riconfermato alla visita di base
    -Il soggetto deve essere in trattamento di backround per tutta la durata dello studio.
    Il trattamento di backround deve essere stabile per 30 giorni prima della linea di base
    e per tutto lo studio con:
    - Antimalarico(i), prednisone (o prednisone-equivalente) (= 20 mg),
    azatioprina (= 150 mg), micofenolato (= 2 g), leflunomide (= 20
    mg), ciclosporina, tacrolimus e/o MTX
    (= 20 mg).
    - La combinazione di un trattamento di fondo con uno o più trattamenti antimalarici e/o
    è consentito il prednisone (o equivalente).
    - E un singolo, ma non multiplo, immunosoppressore aggiuntivo dal
    elenco di cui sopra, è consentito
    E.4Principal exclusion criteria
    • Women of childbearing potential must not have a positive serum
    pregnancy test at the screening visit and must have a negative urine
    pregnancy test at baseline prior to the first dose of study drug. Note:
    Subjects with borderline serum pregnancy tests at Screening must have
    a serum pregnancy test = 3 days later to document continued lack of
    positive result.
    • Must not be using IV or IM corticosteroids greater than or equal to a
    40 mg prednisone-equivalent bolus within 30 days weeks of planned
    randomization
    • Must not have active lupus nephritis (progressive Class IV or >1g/day
    equivalent [1 mg/mg] proteinuria) or have undergone induction therapy within the last 6
    months.
    • Must not have active neuropsychiatric SLE as defined by the CNS
    portion of SLEDAI-2K (excluding lupus headache).
    Subjects must be naïve or have discontinued, if not currently benefiting
    from, the following prior to the first dose of study drug per the
    applicable washout period below or should be at least 5 times the mean
    terminal elimination half-life of a drug:
    · =6 months for Plasmapheresis
    · =3 months for Benlysta
    · =1 year for rituximab OR = 6 months if B cells have returned to =
    50 B cells per microliter
    · =3 months for cyclophosphamide
    • Must not have positive titers for all 3 antiphospholipid antibodies
    known to be associated with venous thrombotic events at Screening:
    lupus anticoagulant, anti-beta 2 glycoprotein 1, and anticardiolipin
    antibody.
    • Le donne in età fertile non devono avere un risultato positivo al test di gravidanza su siero eseguito in occasione della visita di screening e devono avere un risultato negativo al test di gravidanza su urine eseguito al baseline prima della prima dose del medicinale sperimentale. Nota: Nei soggetti con un risultato borderline del test di gravidanza su siero allo Screening, dovrà essere ripetuto il test di gravidanza su siero dopo = 3 giorni, al fine di confermare che il risultato continua a non essere positivo.
    • Non devono essere in trattamento con corticosteroidi EV o IM a dosi pari o superiori a 40 mg di prednisone o equivalente in bolo nei 30 giorni precedenti la data programmata per la randomizzazione
    • Non devono soffrire di nefrite lupica in fase attiva (Classe IV proliferativa, oppure proteinuria > 1g/giorno equivalente [1 mg/mg]), oppure essere stati sottoposti a terapia di induzione nei 6 mesi appena trascorsi.
    • Non devono soffrire di lupus neuropsichiatrico in fase attiva secondo la definizione della porzione relativa all’SNC della classificazione SLEDAI-2K (escluso il mal di testa secondario a lupus).
    • I soggetti devono essere naïve ai seguenti trattamenti, oppure aver interrotto il trattamento se tale trattamento non offre attualmente benefici nel rispetto dell’applicabile periodo di washout indicato di seguito o per un periodo che sia pari ad almeno 5 volte l’emivita terminale media di eliminazione del medicinale, prima della prima dose del medicinale sperimentale:
    - =6 mesi per la plasmaferesi
    - =3 mesi per Benlysta
    - =1 anno per rituximab OPPURE = 6 mesi nel caso in cui il livello di cellule B sia ritornato = 50 cellule B per microlitro (µL)
    - =3 mesi per il ciclofosfamide
    Non deve avere titoli positivi per tutti e 3 gli anticorpi antifosfolipidi
    noto per essere associato ad eventi trombotici venosi allo Screening:
    anticoagulante del lupus, glicoproteina 1 anti-beta 2 e anticardiolipina
    anticorpo.
    E.5 End points
    E.5.1Primary end point(s)
    SLE Responder Index (SRI)-4 and steroid dose = 10 mg prednisone
    equivalent QD. SLE Responder Index (SRI)-4 is defined as = 4-point
    reduction in Systemic Lupus Erythematosus Disease Activity Index 2000
    (SLEDAI-2K) score without worsening of the overall condition (no
    worsening in Physician's Global Assessment [PhGA], < 0.3 point
    increase) or the development of significant disease activity in new organ
    systems (no new British Isles Lupus Assessment Group ([BILAG]) A or >
    1 new BILAG B).
    Punteggio SRI (SLE Responder Index)-4 e dose di steroidi = 10
    mg di prednisone o equivalente una volta al giorno (QD) alla
    settimana 24.
    Il punteggio SRI (SLE Responder Index)-4 è definito come una riduzione di
    = 4 del punteggio Systemic Lupus Erythematosus Disease Activity Index
    2000 (SLEDAI -2K) senza peggioramento delle condizioni generali (no
    peggioramento nel Physician's Global Assessment [PhGA], aumento < 0.3
    punti) o sviluppo di attività significativa di malattia in un nuovo sistema di
    organi (no nuovo British Isles Lupus Assessment Group ([BILAG]) A oppure
    > 1 nuovo BILAG B).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Settimana 24
    E.5.2Secondary end point(s)
    1. SRI-4 (without = 10 mg prednisone equivalent QD requirement)
    2. SRI-5, -6, -7, -8 (and steroid dose = 10 mg prednisone equivalent QD
    at Weeks 24 and 48; without = 10 mg prednisone equivalent QD
    requirement at all other visits)
    3. BILAG-Based Combined Lupus Assessment (BICLA)
    4. Lupus Low Disease Activity State (LLDAS)
    5. 4-point decrease in SLEDAI-2K from Baseline
    6. Steroid burden, assessed as change from Baseline
    7. Number of mild, moderate or severe flares per patient-year
    (respectively and overall) by Safety of Estrogens in Lupus
    Erythematosus National Assessment (SELENA) SLEDAI Flare Index (SFI),
    assessed by number and types of flare per patient compared across
    treatment arms
    8. Time to first flare by SELENA SFI after first study drug administration
    up to Week 24 and Week 48
    9. Achievement of 50% reduction of tender or swollen lupus joints
    (defined as =50% decrease in either tender or swollen joints (among
    those starting with =6 affected joints)
    10. Achievement of 50% reduction in Cutaneous Lupus Erythematosus
    Disease Area and Severity Index (CLASI) activity score (of those starting
    with CLASI =10)
    11. Change in SLEDAI-2K from Baseline
    12. Change in BILAG from Baseline
    13. Change in PhGA from Baseline
    14. Change in Patient Global Assessment (PtGA) from Baseline
    15. Change from Baseline Functional Assessment of Chronic Illness
    Therapy – Fatigue (FACIT-F) at Weeks 2, 12, 24, and 48
    16. Change from Baseline in SF-36 at Weeks 2, 12, 24 and 48
    17. Change from Baseline LupusQoL at Weeks 2, 12, 24 and 48
    18. Change from Baseline Pain Numerical Rating Scale (NRS) at Weeks 2,
    12, 24 and 48
    Endpoint Secondari (relativi all’efficacia, si riferiscono a tutte le visite
    eccetto ove altrimenti precisato):
    1. Punteggio SRI-4 (senza il requisito relativo alla dose di
    steroidi = 10 mg prednisone o equivalente QD)
    2. Punteggio SRI-5, -6, -7, -8 (e dose di steroidi = 10 mg
    prednisone o equivalente QD alle Settimane 24 e 48; senza il
    requisito relativo alla dose di steroidi di = 10 mg prednisone
    o equivalente QD a tutte le altre visite)
    3. Punteggio dell’indice BICLA (Based Combined Lupus
    Assessment) e BILAG
    4. Bassa attività di malattia del lupus in base allo strumento
    LLDAS (Lupus Low Disease Activity State)
    5. diminuizione = 4 punti del punteggio dell’indice SLEDAI -2K
    rispetto la Baseline
    6. Peso del del trattamento con steroidi, valutato sulla base
    della variazione rispetto al Baseline
    7. Numero di lievi, moderati o severi esacerbazioni per annopaziente
    (rispettivamente e complessivamente) calcolato
    con il Safety of Estrogens in Lupus Erythematosus National
    Assessment (SELENA) SLEDAI flare index (SFI), valutato in
    base al numero e al tipo di esacerbazioni per soggetto, nei
    diversi bracci di trattamento
    8. Tempo alla prima esacerbazione in base all’indice relativo
    alle esacerbazioni SELENA SFI dopo la prima
    somministrazione del medicinale sperimentale fino alle
    Settimane 24 e 48
    9. Raggiungimento del 50% della riduzione del numero delle
    articolazioni interessate dal lupus e dolorabili alla palpazione
    oppure tumefatte definito come una riduzione del = 50%
    delle articolazioni tenere o gonfie (nei soggetti con un totale
    di = 6 articolazioni interessate all’ingresso nello studio)
    10. Raggiungimento del 50% della riduzione del 50% del
    punteggio CLASI (Cutaneous Lupus Erythematosus Disease
    Area and Severity Index) relativo all’attività della malattia
    (nei soggetti con un punteggio CLASI = 10 all’ingresso nello
    studio)
    11. Variazione rispetto al Baseline del punteggio SLEDAI-2K
    12. Variazione rispetto al Baseline del punteggio BILAG
    13. Variazione rispetto al Baseline della PhGA
    14. Variazione rispetto al Baseline del Patient Global Assessment
    (PtGA)
    15. Variazione rispetto al Baseline del punteggio FACIT-F
    (Functional Assessment of Chronic Illness Therapy – Fatigue)
    alle Settimane 2, 12, 24 e 48
    16. Variazione rispetto al Baseline del punteggio 36-Item Short
    Form Health Survey (SF-36) alle Settimane 2, 12, 24 e 48
    17. Variazione rispetto al Baseline del punteggio LupusQoL
    (Lupus Quality of Life questionnaire) alle Settimane 2, 12, 24
    e 48
    18. Variazione rispetto al Baseline del dolore misurato mediante
    scala numerica NRS alle Settimane 2, 12, 24 e 48
    E.5.2.1Timepoint(s) of evaluation of this end point
    At all visits unless indicated otherwise.
    Tutte le visite eccetto ove altrimenti precisato
    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 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) 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 trial5
    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 EEA43
    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
    Canada
    China
    Colombia
    Japan
    Korea, Republic of
    Mexico
    New Zealand
    Puerto Rico
    Taiwan
    United States
    France
    Germany
    Hungary
    Italy
    Netherlands
    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
    The end of study is defined as the date of the last subject's last contact, which will be a follow-up phone call 30 days after the last dose
    Per fine dello studio si intende la data dell’ultimo contatto con l’ultimo soggetto, che sarà rappresentato da un contatto telefonico di follow-up 30 giorni dopo l’ultima dose
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 315
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Those that cannot consent on their own to the study for certain purposes per local regulations. The legally authorized representative would fulfil all statutory requirements for the patient.
    Coloro che non possono acconsentire da soli allo studio per determinati scopi, secondo le normative locali. Il rappresentante legalmente autorizzato soddisferà tutti i requisiti di legge per il paziente.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 325
    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)
    The patient will return to standard of care.
    Il paziente riprenderà lo 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 Decision2019-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-22
    P. End of Trial
    P.End of Trial StatusOngoing
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