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    Summary
    EudraCT Number:2016-000642-62
    Sponsor's Protocol Code Number:M14-675
    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:2021-03-11
    Trial results View 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 number2016-000642-62
    A.3Full title of the trial
    M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis
    M14-675, Studio Clinico multicentrico, randomizzato, in doppio cieco e controllato verso placebo di Induzione per valutare l’efficacia e la sicurezza di Upadacitinib (ABT-494) in soggetti con colite ulcerosa in fase attiva di grado da moderato a severo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis
    Studio clinico per valutare l’efficacia e la sicurezza di Upadacitinib (ABT-494) in soggetti con colite ulcerosa in fase attiva di grado da moderato a severo
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberM14-675
    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
    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 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 CodeSUB171384
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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
    Ulcerative Colitis
    Colite Ulcerosa
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    Colite Ulcerosa
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10009900
    E.1.2Term Colitis ulcerative
    E.1.2System Organ Class 10017947 - Gastrointestinal 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 objective of Study M14-675 (Phase 3 induction) is to evaluate the efficacy and safety of upadacitinib 45 mg once daily (QD) compared to placebo in inducing clinical remission (per Adapted Mayo score) in subjects with moderately to severely active ulcerative colitis.
    L’obiettivo dello studio clinico M14-675 (Fase 3 di induzione) è quello di valutare l’efficacia e la sicurezza di upadacitinib 45 mg una volta al giorno (QD) rispetto a placebo nell’indurre la remissione clinica (in base al punteggio Adapted Mayo) in soggetti con colite ulcerosa in fase attiva di grado da moderato a severo.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to evaluate the efficacy of upadacitinib 45 mg QD comparing with placebo in ranked secondary endpoints of achieving endoscopic improvement, endoscopic remission, clinical response per Adapted Mayo Score ,clinical response per Partial
    Adapted Mayo score, no bowel urgency, no abdominal pain, histologic improvement, response in IBDQ Below symptom domain, mucosal healing, UC-related hospitalization, UC-related surgery, and response in IBDQ fatigue item
    Gli obiettivi secondari dello studio intendono valutare l’efficacia di upadacitinib 45 mg QD rispetto a placebo in base agli endpoint secondari ranked relativi ai seguenti parametri: ottenimento del miglioramento endoscopico, della remissione endoscopica, della risposta clinica in base al punteggio Adapted Mayo, della risposta clinica in base al punteggio Partial Adapted Mayo, assenza di sensazione urgente di dover evacuare, assenza di dolore addominale, miglioramento istologico, risposta in base al dominio relativo ai sintomi intestinali del questionario IBQD, guarigione della mucosa, ricoveri ospedalieri dovuti alla colite ulcerosa, interventi chirurgici dovuti alla colite ulcerosa, e risposta in base all'item relativo alla faticabilità del questionario IBQD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female between 18 and 75 years of age at Baseline.
    2. Diagnosis of UC for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in
    the assessment of the Investigator, must be available.
    3. Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader).
    4. Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following including, oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic
    therapies, in the opinion of the investigator, as defined below:
    • Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine,
    balsalazide)
    o Signs and symptoms of persistently active disease, in the opinion of the investigator, during a current or prior course of at least 4 weeks of treatment with 2.4 g/day mesalamine, 4 g/day sulfasalazine, 1 g/day olsalazine, or 6.75 g/day balsalazide.
    • Corticosteroids
    o Signs and symptoms of persistently active disease despite a history of at least one induction regimen that included a dose equivalent to prednisone = 40 mg/day orally for 3 to 4 weeks or intravenously for 1 week, OR
    o Unable to taper corticosteroids to below a dose equivalent to prednisone 10 mg daily orally without recurrent active disease, OR
    o History of intolerance to corticosteroids (including, but not limited to Cushing's syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, infection).
    • Immunosuppressants
    o Signs and symptoms of persistently active disease despite a history of at least one 90 day regimen of oral azathioprine (= 1.5 mg/kg/day; for subjects in Japan, China, and Taiwan only: = 1.0 mg/kg/day), 6-MP (= 1 mg/kg/day; [for subjects in Japan, China, and Taiwan only: = 0.6
    mg/kg/day, rounded to the nearest available tablet of half tablet formulation] or a documented 6-TGN level of 230 – 450 pmol/8 × 108 RBC or higher on the current dosing regimen), injectable MTX (= 15 mg/week subcutaneous [SC] or intramuscular), or tacrolimus (for subjects in Japan and Taiwan only: documented trough level of 5 – 10 ng/mL), OR
    o History of intolerance to at least one immunosuppressant (including, but not limited to nausea/vomiting, abdominal pain, pancreatitis, liver enzyme abnormalities, lymphopenia, infection)
    Note: Oral MTX use is allowed during the study, however prior or current use of oral MTX is not sufficient for inclusion into the study unless these subjects were previously treated with aminosalicylates,
    corticosteroids or immunosuppressants (azathioprine or 6-MP) and have inadequate response to, loss of response to or intolerance to the therapy as defined above.
    • Biologic Agents for UC
    o Signs and symptoms of persistently active disease despite a history of
    any of the following:
    o at least one 6-week induction regimen of infliximab (= 5 mg/kg IV at 0, 2, and 6 weeks),
    o at least one 4-week induction regimen of adalimumab (one 160 mg SC dose followed by one 80 mg SC dose [or one 80 mg SC dose in countries where this dosing regimen is allowed] followed by one 40 mg SC dose at least 2 weeks apart),
    o at least one 2-week induction regimen of golimumab (one 200 mg SC dose followed by one 100 mg SC dose at least 2 weeks apart),
    o at least one 6-week induction regimen of vedolizumab (300 mg IV at 0, 2, and 6 weeks), OR
    1. Soggetti di ambo i sessi di età compresa fra 18 e 75 anni al Baseline.
    2. Diagnosi di colite ulcerosa da 90 giorni o più prima del Baseline, confermata da colonscopia eseguita durante il Periodo di Screening, con l’esclusione di infezione in atto, displasia del colon e/o neoplasia maligna. Dovrà essere disponibile una appropriata documentazione dei risultati della biopsia che, secondo la valutazione dello sperimentatore, confermino la diagnosi di colite ulcerosa.
    3. Colite ulcerosa in fase attiva con punteggio Adapted Mayo Score compreso fra 5 e 9 punti e sottopunteggio endoscopico compreso tra 2 e 3 (confermato da lettore centralizzato).
    4. Soggetti che secondo la valutazione dello sperimentatore hanno dimostrato risposta inadeguata, perdita di risposta o intolleranza ad almeno uno dei seguenti trattamenti compresi aminosalicilati orali, corticosteroidi, immunosoppressori e/o terapie biologiche secondo quanto riportato di seguito:
    • Aminosalicilati orali (ad esempio, mesalamina, sulfasalazina, olsalazina, balsalazide)
    o Segni e sintomi di malattia persistentemente attiva a giudizio dello sperimentatore, durante un trattamento in atto o un trattamento pregresso della durata di almeno 4 settimane con mesalamina 2,4 gr/die, sulfasalazina 4 gr/die, olsalazina 1 gr/die o balsalazide 6,75 gr/die;
    • Corticosteroidi
    o Segni e sintomi di malattia persistente in fase attiva nonostante almeno un pregresso regime di induzione che abbia compreso una dose equivalente a prednisone = 40 mg/die per via orale per un periodo compreso tra le 3 e le 4 settimane oppure per via endovenosa per una settimana, OPPURE
    o Impossibilità a ridurre in maniera graduale i corticosteroidi a un dosaggio inferiore alla dose giornaliera equivalente a prednisone 10 mg per via orale senza il riacutizzarsi della malattia di fase attiva, OPPURE
    o Storia di intolleranza ai corticosteroidi (fra cui, a titolo esemplificativo ma non esaustivo, la sindrome di Cushing, osteopenia/osteoporosi, iperglicemia, insonnia, infezione).
    • Immunosoppressori
    o Segni e sintomi di malattia persistente in fase attiva nonostante almeno un pregresso regime di trattamento della durata di 90 giorni con azatioprina orale (= 1,5 mg/kg/die; esclusivamente per i soggetti in Giappone, Cina e Taiwan: = 1,0 mg/kg/die), 6-MP (= 1 mg/kg/die; [esclusivamente per i soggetti in Giappone, Cina e Taiwan: = 0,6 mg/kg/die, selezionando la compressa più simile/vicina alla formulazione della mezza compressa], oppure livelli documentati di 6-tioguanina nucleotide (6-TGN) compresi tra 230 e 450 pmol/8 x 108 RBC o superiore con il regime di dosaggio in atto), MTX iniettabile (= 15 mg/settimana per via sottocutanea [SC] o per via intramuscolare), oppure tacrolimus (esclusivamente per i soggetti in Giappone e Taiwan: livelli valle documentati pari a 5-10 ng/mL), OPPURE
    o Storia di intolleranza ad almeno un immunosoppressore (fra cui, a titolo esemplificativo ma non esaustivo, nausea/vomito, dolore addominale, pancreatite, alterazione degli enzimi epatici, linfocitopenia, infezione)
    Nota: L’uso di MTX orale è permesso durante lo studio clinico, tuttavia, l’uso pregresso o in atto di MTX orale non è sufficiente per l’inclusione nello studio ad eccezione del caso in cui i soggetti siano stati trattati in precedenza con aminosalicilati, corticosteroidi o immunosoppressori (azatioprina oppure 6-MP) e che abbiano avuto risposta inadeguata, perdita di risposta o intolleranza alla terapia definita sopra.
    • Agenti biologici somministrati per la colite ulcerosa
    o Segni e sintomi di malattia persistente in fase attiva nonostante storia di uno qualsiasi fra i seguenti regimi:
    o almeno un regime pregresso di sei settimane di induzione con infliximab (= 5 mg/kg EV alle settimane 0, 2 e 6)
    o almeno un regime pregresso di quattro settimane di induzione con adalimumab (una dose SC da 160 mg seguita da una dose SC da 80 mg [ oppure una dose SC da 80 mg,
    E.4Principal exclusion criteria
    1. Subject with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC).
    2. Current diagnosis of fulminant colitis and/or toxic megacolon.
    3. Subject with disease limited to the rectum (ulcerative proctitis) during the Screening endoscopy.
    4. Received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days prior to Baseline.
    5. Subject who received azathioprine or 6-MP within 10 days of Baseline.
    6. Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
    7. Subject with previous exposure to JAK inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
    8. Screening laboratory and other analyses show any of the following abnormal results:
    • Serum Aspartate Transaminase (AST) or Alanine Transaminase (ALT) > 2.0 × upper limit of the reference range (ULN);
    • Estimated glomerular filtration rate by simplified 4-variable
    Modification of Diet in Renal Disease (MDRD) formula < 30 mL/min/1.73 m2;
    • Total White Blood Cell (WBC) count < 2500/µL;
    • Absolute neutrophil count (ANC) < 1,200/µL;
    • Platelet count < 100,000/µL;
    • Absolute lymphocytes count < 750/µL;
    • Hemoglobin < 9g/dL.
    1. Soggetto con diagnosi di Malattia di Crohn (CD) in atto oppure diagnosi di colite indeterminata (indeterminate colitis, IC) in atto .
    2. Diagnosi di colite fulminante e/o megacolon tossico in atto.
    3. Soggetto la cui malattia risulta limitata al retto (proctite ulcerosa) all’endoscopia eseguita durante lo Screening.
    4. Soggetto che abbia ricevuto trattamento con ciclosporina, tacrolimus o micofenolato mofetil nei 30 giorni precedenti il Baseline.
    5. Soggetto che abbia ricevuto il trattamento con azatioprina o con 6-MP nei 10 giorni precedenti il Baseline.
    6. Soggetto che ha ricevuto corticosteroidi per via endovenosa nei 14 giorni precedenti lo Screening oppure durante il Periodo di Screening.
    7. Soggetto con esposizione pregressa a inibitori della proteina JAK (ad es., tofacitinib, baricitinib, filgotinib, upadacitinib).
    8. Qualsiasi fra le seguenti alterazioni dei valori di laboratorio allo Screening o di altre analisi:
    • Valori sierici di aspartato aminotransferasi (AST) o alanina aminotransferasi (ALT) > 2,0 x limite superiore di normalità (ULN);
    • Tasso di filtrazione glomerulare stimato mediante formula MDRD semplificata a 4 variabili (Modification of Diet in Renal Disease) < 30 mL/min/1,73 m2;
    • Conta totale dei globuli bianchi (WBC) < 2.500/µL;
    • Conta assoluta dei neutrofili (ANC) < 1.200/µL;
    • Conta delle piastrine < 100.000/µL;
    • Conta assoluta dei linfociti < 750/µL;
    • Emoglobina < 9 g/dL.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for Study M14-675 is the proportion of subjects who achieve clinical remission per Adapted Mayo score (defined as SFS = 1 and not greater than baseline, RBS of 0, and endoscopic sub score = 1) at Week 8.
    L’endpoint primario per lo Studio clinico M14-675 è rappresentato dalla percentuale di soggetti che ottengono la remissione clinica in base al punteggio Adapted Mayo Score (definito come punteggio SFS = 1 e non superiore al baseline, sottopunteggio RBS pari a 0 e sottopunteggio endoscopico = 1) alla Settimana 8.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1: Week 8 and Part 2: Week 16 (Extended Treatment Period; as applicable)
    Parte 1: Settimana 8 e Parte 2: Settimana 16 (Periodo di estensione del trattamento; secondo quanto applicabile
    E.5.2Secondary end point(s)
    1. Proportion of subjects with endoscopic improvement at Week 8
    2. Proportion of subjects with endoscopic remission at Week 8
    3. Proportion of subjects achieving clinical response per Adapted Mayo Score at Week 8
    4. Proportion of subjects achieving clinical response per Partial Adapted Mayo score (defined as decrease from Baseline = 1 points and = 30% from Baseline, PLUS a decrease in RBS = 1 or an absolute RBS = 1 )at Week 2
    5. Proportion of subjects who reported no bowel urgency at Week 8
    6. Proportion of subjects who reported no abdominal pain at Week 8
    7. Proportion of subjects who achieved histologic improvement (defined as decrease from Baseline in Geboes score) at Week 8
    8. Proportion of subjects achieving response in IBDQ Bowel Symptom domain (increase of IBDQ bowel symptom domain score =6) at Week 8
    9. Proportion of subjects with mucosal healing (endoscopic and histologic remission) at Week 8
    10. Proportion of subjects with UC-related hospitalizations through Week 8
    11. Proportion of subjects with UC-related surgeries through Week 8
    12. Proportion of subjects achieving response in IBDQ fatigue item (increase of IBDQ fatigue item score =1) at Week 8.
    1. Percentuale di soggetti con miglioramento endoscopico alla Settimana 8
    2. Percentuale di soggetti con remissione endoscopica alla Settimana 8
    3. Percentuale di soggetti che ottengono risposta clinica in base al punteggio Adapted Mayo Score alla Settimana 8
    4. Percentuale di soggetti che ottengono risposta clinica in base al punteggio Partial Adapted Mayo score (definita come riduzione rispetto al Baseline = 1 punto e = 30% rispetto al Baseline, IN AGGIUNTA a una riduzione del valore di RBS = 1 oppure un valore RBS assoluto = 1) alla Settimana 2
    5. Percentuale di soggetti che non hanno riferito alcuna sensazione di urgenza alla Settimana 8
    6. Percentuale di soggetti che non hanno riferito alcun dolore addominale alla Settimana 8
    7. Percentuale di soggetti che hanno ottenuto il miglioramento istologico (definito come riduzione rispetto al Baseline nel punteggio Geboes) alla Settimana 8
    8. Percentuale di soggetti che hanno ottenuto la risposta nel punteggio IBDQ, dominio relativo al Sintomi Intestinali (aumento del punteggio IBDQ-dominio relativo ai sintomi intestinali = 6) alla Settimana 8
    9. Percentuale di soggetti con guarigione della mucosa (remissione endoscopica ed istologica) alla Settimana 8
    10. Percentuale di soggetti con ricoveri ospedalieri richiesti per la colite ulcerosa fino alla Settimana 8
    11. Percentuale di soggetti sottoposti a interventi chirurgici per la colite ulcerosa fino alla Settimana 8
    12. Percentuale di soggetti che ottengono la risposta IBDQ – item relativo alla faticabilità (aumento del punteggio IBDQ item relativo alla faticabilità = 1 alla Settimana 8
    E.5.2.1Timepoint(s) of evaluation of this end point
    For points 1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 12 - week 8
    For point 4 - Week 2
    Per i punti 1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 12 – settimana 8
    Per il punto 4 – Settimana 2
    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 No
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA175
    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
    Argentina
    Australia
    Belarus
    Bosnia and Herzegovina
    Brazil
    Canada
    Chile
    China
    Colombia
    Croatia
    Israel
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    Norway
    Puerto Rico
    Russian Federation
    Serbia
    Singapore
    South Africa
    Switzerland
    Taiwan
    Turkey
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months23
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months23
    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: 439
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 462
    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 who complete M14-675 and have confirmed clinical response will have the option to participate in the M14-234 sub-study 3 maintenance study (duration 52 weeks). Subjects that either complete 52 weeks of treatment or confirm loss of response as defined in the M14-234 protocol will also have the option to participate in the M14- 533 long term extension study that allows for treatment for up to 72 months.
    Soggetti che completateranno lo studio M14-675 e che hanno confermato la risposta clinica, avranno l’opzione di partecipare al sottostudio 3 dello studio di mantenimento M14-234 (di 52 settimane). I soggetti che avranno completato le 52 settimane di trattamento, o per cui sia confermata la perdita di risposta secondo il protocollo dello studio M14-234 è prevista anche la possibilità di partecipare allo studio di estensione a lungo termine M14-533 dove il trattamento può durare fino a 72 mesi.
    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 Decision2019-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-14
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