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    Summary
    EudraCT Number:2018-002629-51
    Sponsor's Protocol Code Number:CNTO1275CRD3008
    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:2021-06-15
    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 number2018-002629-51
    A.3Full title of the trial
    A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease
    Uno studio multicentrico di fase 3b randomizzato, in doppio cieco per valutare la sicurezza e l’efficacia della terapia di reinduzione per via endovenosa con ustekinumab in pazienti con malattia di Crohn ad attività moderata-severa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive Tract
    Uno studio clinico per valutare la sicurezza e l’efficacia della terapia di reinduzione per via endovenosa con ustekinumab in pazienti con malattia di Crohn ad attività moderata-severa che colpisce il rivestimento del tratto digestivo
    A.3.2Name or abbreviated title of the trial where available
    Patient Optimization With ustekinumab Re-induction (POWER)
    Ottimizzazione del paziente con ri-induzione di ustekinumab (POWER)
    A.4.1Sponsor's protocol code numberCNTO1275CRD3008
    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 NV Belgium
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportJanssen-Cilag SpA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International N.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.5.6E-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 Yes
    D.2.1.1.1Trade name STELARA - 90 MG SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - FLACONCINO (VETRO) 1.0 ML (90 MG/ML) 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG INTERNATIONAL N.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameUstekinumab
    D.3.2Product code [CNTO1275]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNUSTEKINUMAB
    D.3.9.1CAS number 815610-63-0
    D.3.9.2Current sponsor codeCNTO1275
    D.3.9.3Other descriptive nameustekinumab
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 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 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.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 Yes
    D.2.1.1.1Trade name STELARA - 45 MG SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - FLACONCINO (VETRO) 0.5 ML (90 MG/ML) 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG INTERNATIONAL N.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameUSTEKINUMAB
    D.3.2Product code [CNTO1275]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUSTEKINUMAB
    D.3.9.1CAS number 815610-63-0
    D.3.9.2Current sponsor codeCNTO1275
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 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
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn’s Disease
    Morbo di Crohn
    E.1.1.1Medical condition in easily understood language
    A chronic inflammatory bowel disease that affects the lining of the digestive tract
    Una malattia infiammatoria cronica intestinale che colpisce il rivestimento del tubo digerente
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    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 primary objective is to evaluate the achievement of clinical response at Week 16 following a single intravenous (IV) re-induction dose of ~6 milligram per kilogram (mg/kg) ustekinumab, compared with continuing regular subcutaneous (SC) dosing every 8 weeks (q8w) 90 milligram (mg) ustekinumab administration, in participants with secondary loss of response (LoR) to SC q8w 90 mg ustekinumab maintenance therapy.
    L’obiettivo primario è valutare l’ottenimento della risposta clinica alla Settimana 16 dopo una singola dose di reinduzione con ~6 mg/kg di ustekinumab EV, rispetto alla prosecuzione della normale somministrazione di 90 mg di ustekinumab SC q8w (una volta ogni 8 settimane), in partecipanti con perdita di risposta (LoR) secondaria alla terapia di mantenimento con 90 mg di ustekinumab SC q8w.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to:
    ¿ Evaluate the achievement of clinical response and clinical remission, as well as the reduction in inflammatory biomarkers (serum C-reactive protein [CRP] and fecal calprotectin [fCal] levels), after IV ustekinumab re-induction.
    ¿ Assess the overall safety of IV ustekinumab re-induction.
    Gli obiettivi secondari sono i seguenti:
    • Valutare l’ottenimento della risposta clinica e della remissione clinica, oltre che della riduzione dei biomarcatori infiammatori (livelli di proteina C-reattiva [PCR] nel siero e calprotectina fecale [fCal]), dopo la reinduzione con ustekinumab EV.
    • Valutare la sicurezza globale della reinduzione con ustekinumab EV.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each potential participant must satisfy all the following criteria to be enrolled in the study:
    1. Male or female aged =18 years (or the legal age of consent in the jurisdiction in which the study is taking place if older than 18 years).
    2. A history of Crohn’s disease or fistulizing Crohn’s disease of at least 3 months’ duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy.
    3. Initially responded to ustekinumab induction therapy (a), administered according to the local label, followed by secondary LoR to ustekinumab (b).
    a) Initial response to ustekinumab as defined in Section 10.2.
    b) Secondary LoR to ustekinumab is defined as active disease at study baseline, proven by a crohn’s disease activity index (CDAI) score of =220 and =450 with at least one of the following:
    - Elevated CRP (>3.0 milligram per litre [mg/L]); and/or
    - Elevated FeCa (>250 mg/kg); and/or
    - Endoscopy (performed within the 3 months before baseline) with evidence of active Crohn’s disease (defined as one or more ulcerations in the ileum and/or colon).
    4. The following medications for the treatment of Crohn’s disease are permitted providing the doses indicated are stable for at least 3 weeks before baseline or have been discontinued at least 3 weeks before baseline:
    ¿ Oral 5-aminosalicylic acid (5-ASA) compounds.
    ¿ Oral corticosteroids (eg, prednisone, budesonide) at a prednisone-equivalent dose of =40 mg/day or =9 mg/day of budesonide.
    ¿ Antibiotics used as the primary treatment of Crohn’s disease.
    ¿ Any participants receiving conventional immunomodulators (ie, azathioprine
    [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]) must have been taking them for =12 weeks and must have been on a stable dose for a least 4 weeks before baseline.
    5. The following laboratory test results are within the specified limits at screening:
    ¿ Hemoglobin =8.5 g/dL (=85 g/L).
    ¿ White blood cell (WBC) count =3.5 x 10^3/µL (=3.5 GI/L).
    ¿ Neutrophils =1.5 x 10^3/µL (=1.5 GI/L).
    ¿ Platelets =100 x 10^3/µL (=100 GI/L).
    ¿ Serum creatinine <1.7 mg/dL (=133 µmol/L).
    ¿ Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase levels =2 times the upper limit of normal for the laboratory conducting the test.
    ¿ Direct (conjugated) bilirubin <1.0 mg/dL (<0.01 g/L).
    6. Meet the following TB screening criteria:
    ¿ No history of latent or active TB before screening. An exception is made for participants who have a history of latent TB and are currently receiving treatment for latent TB, will initiate treatment for latent TB prior to first administration of study intervention, or have documentation of having completed appropriate treatment for latent TB within 5 years prior to the first administration of study intervention. It is the responsibility of the investigator to verify the adequacy of previous TB treatment and provide appropriate documentation.
    Please see protocol for an overview of all inclusion criteria, included those modified with amendment to protocol AM4
    1.Uomini o donne di età =18 anni (o la maggiore età legale nella giurisdizione in cui si svolge lo studio se superiore a 18 anni). 2.Storia di malattia di Crohn o malattia di Crohn fistolizzante con durata di almeno 3 mesi con colite, ileite o ileocolite, confermata in precedenza da radiografia, esame istologico e/o endoscopia. 3.Risposta iniziale alla terapia di induzione con ustekinumaba, somministrata secondo l’etichetta locale, seguita da LoR secondaria a ustekinumabb. a.La risposta iniziale a ustekinumab è definita nella Sezione 10.2, Appendice 2 del protocollo di studio. b.La LoR secondaria a ustekinumab è definita come malattia attiva al basale dello studio, dimostrata da un punteggio CDAI compreso tra =220 e =450 associato ad almeno uno dei seguenti elementi: PCR elevata (>3,0 mg/L) e/o; FeCa elevata (>250 mg/kg) e/o; Endoscopia (eseguita entro i 3 mesi precedenti al basale) con evidenza di malattia di Crohn attiva durante l’esacerbazione in corso (caratterizzata come una o più ulcerazioni a carico dell’ileo e/o del colon). 4.I farmaci per il trattamento della malattia di Crohn elencati di seguito sono consentiti a condizione che le dosi indicate siano stabili da almeno 3 settimane prima del basale o siano state interrotte almeno 3 settimane prima del basale: Composti di acido 5-aminosalicilico (5-ASA) per assunzione orale; Corticosteroidi orali (ad es. prednisone, budesonide) a una dose equivalente di prednisone =40 mg/giorno o di budesonide =9 mg/giorno; Antibiotici utilizzati come trattamento primario della malattia di Crohn; I partecipanti che ricevono farmaci immunomodulatori convenzionali (ad es. azatioprina [AZA], 6-mercaptopurina [6-MP] o metotrexato [MTX]) devono aver assunto tali farmaci per =12 settimane e a dose stabile per almeno le 4 settimane precedenti al basale.5.Risultati delle seguenti analisi di laboratorio compresi entro i limiti specificati allo screening: Emoglobina =8,5 g/dL (=85 g/L); Conta leucocitaria (WBC) =3,5 x 103/µL (=3,5 GI/L); Neutrofili =1,5 x 103/µL (=1,5 GI/L); Piastrine =100 x 103/µL (=100 GI/L); Creatinina sierica =1,7 mg/dL (=133 µmol/L); I livelli di aspartato aminotransferasi (AST), alanina aminotransferasi (ALT) e fosfatasi alcalina devono essere =2 volte il limite superiore della norma per il laboratorio che esegue l’analisi; Bilirubina diretta (coniugata) <1,0 mg/dL (<0,01 g/L).6.Idoneità ai seguenti criteri relativi alla TBC allo screening:Nessuna storia di TBC latente o attiva prima dello screening. Fanno eccezione i partecipanti con una storia di TBC latente e attualmente sottoposti a trattamento per TBC latente, i partecipanti che inizieranno il trattamento per TBC latente prima della prima assunzione dell’intervento dello studio e i pazienti con una documentazione che accerta l’avvenuto completamento del trattamento appropriato per TBC latente nei 5 anni precedenti alla prima somministrazione dell’intervento dello studio. È responsabilità dello sperimentatore verificare l’adeguatezza della terapia antitubercolare fornendo idonea documentazione. Nessun segno o sintomo potenzialmente riconducibile a TBC attiva sulla base di anamnesi e/o esame obiettivo. Nessun recente contatto ravvicinato con persone con TBC attiva. In caso di contatto, i partecipanti saranno sottoposti a valutazione supplementare da parte di un medico specialista per tale patologia e, se necessario, riceveranno un opportuno trattamento per la TBC latente prima o contemporaneamente alla prima somministrazione dell’intervento dello studio. Entro le 8 settimane precedenti alla prima somministrazione dell’intervento dello studio, risultato negativo al test QuantiFERON®-TB oppure un risultato positivo al test QuantiFERON-TB di recente identificazione se viene esclusa la presenza di TBC attiva e viene iniziato un opportuno trattamento per la TBC latente prima della prima somministrazione dell’intervento dello studio. Per tutti i criteri di inclusione si prega di far riferimento al protocollo. -
    E.4Principal exclusion criteria
    1.Complications of Crohn’s disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with ustekinumab.
    2.Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided there is no anticipated need for any further surgery. Participants with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified.
    3.Any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months before baseline.
    4.A draining (ie, functioning) stoma or ostomy.
    5.Received any of the following prescribed medications or therapies within the specified period:
    ¿Any off-label use of ustekinumab, including additional IV re-induction or shortened frequency of subcutaneous dose administration, after the initial weight-tiered based IV induction dose of ustekinumab.
    ¿Intravenous corticosteroids as a treatment for Crohn’s disease within 3 weeks before baseline.
    ¿Oral immunomodulatory agents other than AZA, 6-MP, or MTX (eg, Janus kinase [JAK] inhibitors, 6-thioguanine [6-TG], cyclosporine, tacrolimus, sirolimus, tofacitinib, or mycophenolate mofetil) within 4 weeks before baseline.
    ¿Any other investigational agent for Crohn’s disease (eg other biologics, small molecules or anti-sense RNA such as mongersen), unless at least 3 months or 5 half-lives (whichever is longer) have elapsed since the last dose.
    ¿Treatment with apheresis (eg, Adacolumn apheresis) or total parenteral nutrition as a treatment for Crohn’s disease within 3 weeks before baseline.
    6.A stool culture or other examination in the last 4 months that is positive for an enteric pathogen, including Clostridium difficile toxin, unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen.
    7.Received a Bacille Calmette-Guérin (BCG) vaccination within 12 months before baseline or any other live bacterial or live viral vaccination within 2 weeks before baseline.
    8.A history of, or ongoing, chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection, recurrent urinary tract infection (eg, recurrent pyelonephritis or chronic nonremitting cystitis), or open, draining, or infected skin wounds or ulcers.
    9.Any current signs or symptoms of infection. Established non-serious infections (eg, acute upper respiratory tract infection, simple urinary tract infection) need not be considered exclusionary at the discretion of the investigator.
    10.A history of serious infection (eg, sepsis, pneumonia, or pyelonephritis), including any infection requiring hospitalization or IV antibiotics, for 8 weeks before baseline.
    11.Evidence of a herpes zoster infection =8 weeks before baseline.
    12.A history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening; refer to Inclusion Criterion 6 for information regarding eligibility with a history of latent TB.
    Please see protocol for an overview of all exclusion criteria, included those modified with amendment to protocol AM4
    1. Complicazioni della malattia di Crohn quali tratti ristretti o stenosi sintomatici, sindrome dell’intestino corto o qualsiasi altra manifestazione che potrebbe lasciar supporre la necessità di un intervento chirurgico, precludere l’utilizzo del punteggio CDAI per la valutazione della risposta alla terapia o confondere potenzialmente la capacità di valutazione dell’effetto del trattamento con ustekinumab. 2.Ascesso presunto o in corso. Gli ascessi cutanei e perianali recenti non costituiscono un criterio di esclusione se drenati e adeguatamente trattati almeno 3 settimane prima del basale (o 8 settimane prima del basale in caso di ascessi intra-addominali), purché non si preveda la necessità di ulteriori interventi chirurgici. I partecipanti con fistole attive possono essere inclusi se non si ipotizza la necessità di intervenire chirurgicamente e non sono stati identificati ascessi in corso. 3.Qualsiasi tipo di resezione intestinale avvenuta entro i 6 mesi precedenti al basale o qualsiasi altro intervento intra-addominale avvenuto entro i 3 mesi precedenti al basale. 4.Stoma o ostomia drenante (funzionante). 5.Assunzione di uno qualsiasi dei seguenti farmaci o terapie prescritti entro il periodo specificato: Qualsiasi utilizzo off-label di ustekinumab, compresa la reinduzione EV supplementare o una frequenza abbreviata di somministrazione della dose sottocutanea, dopo la dose di induzione iniziale con ustekinumab EV calcolata in base al peso;Corticosteroidi per via endovenosa come trattamento per la malattia di Crohn entro le 3 settimane precedenti al basale; Agenti immunomodulatori orali diversi da AZA, 6-MP e MTX (ad es., inibitori delle Janus chinasi [JAK], 6-tioguanina [6-TG], ciclosporina, tacrolimus, sirolimus, tofacitinib o mofetil micofenolato) entro le 4 settimane precedenti al basale.
    • Qualsiasi altro agente sperimentale per la malattia di Crohn (ad es., altri agenti biologici, piccole molecole o RNA antisenso come mongersen) a meno che non siano trascorsi almeno 3 mesi o 5 emivite (a seconda del periodo più lungo) dall’ultima dose.
    • Trattamento con aferesi (ad es., aferesi con Adacolumn) o nutrizione parenterale totale quale trattamento per la malattia di Crohn entro le 3 settimane precedenti al basale.
    6. Una coprocoltura o un altro esame eseguito entro i 4 mesi precedenti positivo a un patogeno enterico, compresa la tossina del Clostridium difficile, a meno che la ripetizione dell’esame non fornisca un risultato negativo e non emergano i segni di un’eventuale infezione in corso legata a tale patogeno.
    7. Vaccino Bacille Calmette-Guérin (BCG) ricevuto entro i 12 mesi precedenti al basale o qualsiasi altro vaccino virale o batterico vivo ricevuto entro le 2 settimane precedenti al basale.
    8. Malattia infettiva cronica o ricorrente presente in anamnesi o in corso, comprese, a titolo esemplificativo, infezione renale cronica, infezione al torace cronica, infezione ricorrente delle vie urinarie (ad es. pielonefrite ricorrente o cistite cronica non remittente), oppure ulcere o ferite cutanee aperte, drenanti o infette.
    9. Qualsiasi segno o sintomo attuale di infezione. A discrezione dello sperimentatore, non è necessario considerare quale criterio di esclusione le infezioni non serie accertate (ad es., infezione acuta delle vie respiratorie superiori, infezione semplice delle vie urinarie).
    10. Storia di grave infezione (ad es., sepsi, polmonite o pielonefrite), compresa qualsiasi infezione che abbia richiesto ricovero ospedaliero o somministrazione di antibiotici EV, entro le 8 settimane precedenti al basale.
    11. Evidenza di infezione da herpes zoster = 8 settimane prima del basale.
    12. Storia di infezione granulomatosa latente o attiva, compresa istoplasmosi o coccidioidomicosi, prima dello screening; fare riferimento al criterio di inclusione 6 per informazioni in merito all’idoneità dei partecipanti con storia di TBC latente. -
    Per tutti i criteri di esclusione si prega di far riferimento al protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is clinical response at Week 16, defined as a =100-point reduction from the baseline CDAI score or a CDAI score <150 points
    L’endpoint primario è la risposta clinica alla Settimana 16, definita come una riduzione di =100 punti del punteggio CDAI (Crohn’s Disease Activity Index) basale o un punteggio CDAI <150
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 16
    alla 16 settimana
    E.5.2Secondary end point(s)
    1. Clinical remission at Week 16, defined as a CDAI score of <150 points.
    2. Clinical response at Week 8, defined as a =100-point reduction from the baseline CDAI score or a CDAI score <150.
    3. Clinical remission at Week 8, defined as a CDAI score of <150 points.
    4. Normalization of CRP and/or fCal concentration(s) at Week 16, among participants with an elevated CRP and/or fCal at baseline.
    5. Clinical remission at Week 24, defined as a CDAI score of <150 points.
    6. Clinical response at Week 24, defined as a =100-point reduction from the baseline CDAI score or a CDAI score <150.
    7. Normalization of CRP and/or fCal concentration(s) at Week 24, among participants with an elevated CRP and/or fCal at baseline.
    8. Safety endpoints, including the proportion of participants with at least one adverse event and subcategories of adverse events (all infections, all serious adverse events and serious infections), as well as changes in clinical laboratory test results.
    • Remissione clinica alla Settimana 24, definita come un punteggio CDAI <150.
    • Risposta clinica alla Settimana 24, definita come una riduzione di =100 punti del punteggio CDAI basale o un punteggio CDAI <150.
    • Normalizzazione delle concentrazioni di PCR e/o fCal alla Settimana 24, tra i partecipanti con livelli elevati di PCR e/o fCal al basale.
    • Endpoint di sicurezza, tra cui la percentuale di partecipanti con almeno un evento avverso e le sottocategorie di eventi avversi (tutte le infezioni, tutti gli eventi avversi seri e le infezioni serie) e le variazioni dei risultati delle analisi cliniche di laboratorio.
    Gli endpoint esplorativi sono descritti nella Sezione 3 del protocollo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 & 4. At week 16
    2 & 3. At week 8
    5, 6 & 7. At week 24
    8. Throughout the study (Screening to week 24 or early termination)
    1 & 4. alla settimana 16
    2 & 3. alla settimana 8
    5, 6 & 7. alla settimana 24
    8.Durante lo studio (Screening alla settimana 24 o risoluzione anticipata)
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker assessments
    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) 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    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
    United States
    Germany
    Netherlands
    Spain
    Sweden
    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 years1
    E.8.9.1In the Member State concerned months3
    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 months3
    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: 185
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 200
    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)
    None
    nessuno
    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 Decision2019-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-01-11
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