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    Summary
    EudraCT Number:2017-004292-31
    Sponsor's Protocol Code Number:RPC01-3201
    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:2021-02-02
    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 number2017-004292-31
    A.3Full title of the trial
    Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease
    Studio di induzione N. 1 - Studio di fase III, multicentrico, randomizzato, in doppio cieco, controllato con placebo volto aper valutare ozanimod somministrato per via orale come terapia di induzione in pazienti soggetti affetti da morbo Morbo di Crohn da moderatamente a gravemente attivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease
    Studio multicentrico di ozanimod somministrato per via orale come terapia di induzione in soggetti  affetti da Morbo di Crohn da moderatamente a gravemente attivo
    A.3.2Name or abbreviated title of the trial where available
    Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Acti
    Studio multicentrico di ozanimod somministrato per via orale come terapia di induzione in soggetti
    A.4.1Sponsor's protocol code numberRPC01-3201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03440372
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1203-7225
    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 SponsorCELGENE INTERNATIONAL II SàRL
    B.1.3.4CountrySwitzerland
    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 supportCelgene International II Sarl
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene International II Sàrl
    B.5.2Functional name of contact pointKeith Usiskin
    B.5.3 Address:
    B.5.3.1Street AddressRue du Pré-Jorat 14
    B.5.3.2Town/ cityCouvet
    B.5.3.3Post code2108
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0019088976550
    B.5.5Fax number0019088607510
    B.5.6E-mailkusiskin@celgene.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 nameozanimod
    D.3.2Product code [RPC1063]
    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 INNOzanimod
    D.3.9.2Current sponsor codeRPC1063
    D.3.9.4EV Substance CodeSUB181335
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 nameozanimod
    D.3.2Product code [RPC1063]
    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 INNOzanimod
    D.3.9.2Current sponsor codeRPC1063
    D.3.9.4EV Substance CodeSUB181335
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderately to Severely Active Crohn’s Disease
    Morbo di Crohn da moderatamente a gravemente attivo
    E.1.1.1Medical condition in easily understood language
    Crohn’s Disease
    Morbo di Crohn
    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 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
    Demonstrate the efficacy of ozanimod compared to placebo on the induction of clinical remission
    Dimostrare l’efficacia di ozanimod rispetto a placebo nell’indurre la remissione clinica.
    E.2.2Secondary objectives of the trial
    - Demonstrate the efficacy of ozanimod compared to placebo on induction of clinical response, clinical remission, endoscopic response, endoscopic remission, and histologic improvement
    - Demonstrate the efficacy of ozanimod compared to placebo, in subjects who had previously received biologic therapy (eg, anti-IL-12, anti-IL-23, anti-TNF, or anti-integrin therapy)
    - Characterize the population pharmacokinetics (PK) and PK/pharmacodynamics (PD) relationship of ozanimod
    - Demonstrate the safety and tolerability of ozanimod as induction therapy
    - Dimostrare l’efficacia di ozanimod rispetto a placebo nell’indurre la risposta clinica, la remissione clinica, la risposta endoscopica, la remissione endoscopica e il miglioramento istologico.
    - Dimostrare l’efficacia di ozanimod rispetto a placebo in soggetti precedentemente trattati con terapia biologica (ad es. anti-IL-12, anti-IL-23, anti-TNF o anti integrina).
    - Definire la farmacocinetica (PK) di popolazione e il rapporto farmacocinetica/farmacodinamica (PD) per ozanimod.
    - Dimostrare la sicurezza e la tollerabilità di ozanimod come terapia di induzione
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects aged 12 to 75 years (at Screening), inclusive with adolescents (12 to 17) with a body weight >= 45 kg
    2. Note: Subjects should not have any constraints under local regulations and must provide written informed consent prior to any study-related procedures, and have the ability to comply with the Table of Events. For adolescents, a parent/legal guardian of the adolescent must sign the informed consent form. In addition, adolescent subjects must also agree to participate in the study by signing an assent form. A parent or guardian must be willing to supervise adherence to the protocol requirements. Adolescent subjects who reach the legal age of consent while participating in the study will be asked to sign an ICF themselves to acknowledge their willingness to continue in the study.
    3. Subject has signs and symptoms consistent with a diagnosis of CD for at least 3 months (prior to first IP administration). The diagnosis should be confirmed by clinical and endoscopic evidence and corroborated by a histology report. (Note: endoscopy and histopathology confirmation may be obtained during Screening if no prior report is readily available).
    4. Subject has met each of the following 2 criteria:
    ¿ a CDAI score >= 220 and <= 450
    ¿ an average daily stool frequency >= 4 points and/or an abdominal pain of >= 2 points.
    5. Subject has a SES-CD score of >= 6 (or SES-CD >= 4 in subjects with isolated ileal disease).
    6. Subject has an inadequate response or loss of response to or is intolerant of at least 1 of the following CD treatments: corticosteroids, immunomodulators, biologic therapy (eg, ustekinumab, TNFa antagonists, or vedolizumab).
    7. If the subject is taking the following background therapies for CD, he/she must be on a
    stable dose as indicated below:
    ¿ oral aminosalicylates (eg, mesalamine, sulfasalazine, olsalazine, balsalazide) with a stable dose for at least 3 weeks prior to Screening endoscopy
    ¿ prednisone (doses <= 20 mg per day) or equivalent with a stable dose for at least 2 weeks prior to Screening endoscopy
    ¿ budesonide therapy (doses <= 9 mg per day) or beclomethasone doses <= 5 mg/day at a stable dose for at least 2 weeks prior to the Screening endoscopy.
    8. Subject at high risk (ie, family history, CD duration) for colonic malignancy has documented evidence of having had a surveillance colonoscopy within the last 2 years or according to local and national medical guidelines to evaluate for polyps, dysplasia, or malignancy. If there is no recent history of surveillance colonoscopy, this can be done as part of the colonoscopy performed during Screening. Any visualized adenomatous polyps must be removed and any suspicious lesion confirmed free of cancer and/or dysplasia prior to randomization.
    9. Female subjects of childbearing potential (FCBP):
    Must agree to practice a highly effective method of contraception throughout the study until completion of the 90-day Safety Follow-Up Visit. Please refer to study protocol for complete inclusion criteria
    10. Subjects must have documentation of positive varicella zoster virus
    (VZV) immunoglobulin G (IgG) antibody status or complete VZV
    vaccination at least 30 days prior to randomization.
    1. Soggetti di ambo i sessi, di età compresa tra 12 e 75 anni (allo Screening), estremi inclusi, con adolescenti (età compresa tra 12 e 17 anni) con peso corporeo >= 45 kg.
    2. N.B.: I soggetti dovranno essere privi di vincoli legati alle normative locali e dovranno fornire il proprio consenso informato scritto prima di qualunque procedura correlata allo studio ed essere in grado di attenersi a quanto previsto dalla Tabella degli eventi. Per gli adolescenti, il modulo di consenso informato dovrà essere firmato da un genitore o un tutore legale. Inoltre, anche i soggetti adolescenti dovranno accettare di partecipare allo studio firmando un modulo di assenso. Un genitore o un tutore dovrà impegnarsi a supervisionare l’aderenza ai requisiti del protocollo. I soggetti adolescenti che raggiungeranno l’età di consenso legale durante la partecipazione allo studio dovranno firmare personalmente un modulo di consenso informato per confermare l’intenzione di proseguire lo studio.
    3. Soggetti con segni e sintomi coerenti con una diagnosi di morbo di Crohn per almeno 3 mesi (prima della prima dose del prodotto sperimentale). La diagnosi dovrà essere confermata clinicamente ed endoscopicamente e supportata da un referto istologico. (N.B.: la conferma endoscopica e istopatologica potrà avvenire durante lo Screening qualora non fossero prontamente disponibili referti precedenti).
    4. Soggetti che soddisfino entrambi i 2 criteri seguenti.
    • Punteggio CDAI >=220 e <=450
    • Punteggio giornaliero medio relativo alla frequenza di evacuazione =4 punti e/o punteggio relativo al dolore addominale >=2 punti.
    5. Soggetti con punteggio SES-CD >=6 (oppure SES-CD >=4 in soggetti con malattia che interessa esclusivamente l’ileo).
    6. Soggetti che hanno mostrato una risposta inadeguata, hanno perso la risposta o sono risultati intolleranti ad almeno 1 dei seguenti trattamenti per il morbo di Crohn: corticosteroidi; mmunomodulatori;
    terapia biologica (ad es. ustekinumab, antagonisti del TNFa o vedolizumab).
    7. Se il soggetto sta assumendo le seguenti terapie di base per il morbo di Crohn, la dose dovrà essere stabile, secondo quanto indicato di seguito:
    • aminosalicilati orali (ad es. mesalamina, sulfasalazina, olsalazina, balsalazide) in dose stabile per almeno 3 settimane prima dell’endoscopia dello Screening;
    • prednisone (dosi <=20 mg/die) o farmaco equivalente in dose stabile per almeno 2 settimane prima dell’endoscopia dello Screening;
    • terapia a base di budesonide (dosi <=9 mg/die) oppure dosi di beclometasone <=5 mg/die in dose stabile per almeno 2 settimane prima dell’endoscopia dello Screening.
    8. I soggetti ad alto rischio (ad es. per anamnesi familiare, morbo di Crohn di lungo decorso) di neoplasie maligne del colon devono disporre di evidenze documentali relative all’esecuzione di una colonscopia di sorveglianza eseguita nel corso degli ultimi 2 anni o secondo quanto previsto dalle linee guida mediche locali e nazionali, al fine di valutare la presenza di polipi, displasia o neoplasie maligne. In caso di mancata esecuzione di una colonscopia di sorveglianza recente, questa potrà coincidere con la colonscopia effettuata durante lo Screening. In caso fossero visualizzati polipi adenomatosi, questi dovranno essere asportati così come dovrà essere confermata l’assenza di malignità e/o displasia in qualunque lesione sospetta prima della randomizzazione.
    9. Soggetti di sesso femminile in età fertile ( FCBP):
    Queste pazienti dovranno acconsentire a far uso di un metodo contraccettivo altamente efficace per tutta la durata dello studio, fino al completamento della visita del Follow-up di sicurezza a 90 giorni. Fare riferimento al Protocollo per il criterio completo
    10. Per i soggetti deve essere disponibile documentazione comprovante positività per anticorpi IgG anti varicella zoster (VZV) oppure vaccinazione completa anti-VZV portata a termine almeno 30 giorni prima della randomizzazione.
    E.4Principal exclusion criteria
    1. Subject has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study. 2. Subject is likely to require, in the physician's judgment, bowel resection within 12 weeks of entry into the study. 3. Subject has a diagnosis of UC, indeterminate colitis, radiation colitis, or ischemic colitis, or has known strictures or stenosis leading to symptoms of obstruction. 4. Subject has current stoma, ileal-anal pouch anastomosis, symptomatic fistula, draining pus that is likely to require, surgical or
    medical intervention within 12 weeks of entry into the study oror need for ileostomy or colostomy.
    5. Subject has extensive small bowel resection (> 100 cm) or known diagnosis of short bowel syndrome, or subject requires total parenteral nutrition. 6. Subject has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated.
    7. Subject has documentation of a positive test for toxin producing C. difficile, or PCR examination of the stool on their most recent test, which must have been done in the past 60 days. 8. Subject has documentation of positive examination for pathogens (ova and parasites, and bacteria), which must have been done in the past 60 days. 9. Subject is pregnant, lactating, or has a positive serum beta human chorionic gonadotropin (ß-hCG) measured during Screening. 10. Subject has clinically relevant cardiovascular conditions, making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study 11. Subject has a history of uveitis (within the last year) or clinically confirmed diagnosis of macular edema 12. Subject has a known active bacterial, viral, fungal, mycobacterial infection, or other infection or any major episode of infection that required hospitalization or treatment with IV antibiotics within 30 days of Screening or oral antibiotics within 14 days of Screening 13. History or known presence of recurrent or chronic infection (eg, hepatitis B virus [HBV], hepatitis C virus [HCV], human immunodeficiency virus [HIV]); recurrent urinary tract infections are allowed 14. Subject has a history of active cancer within 5 years, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin or cervical dysplasia/cancer that have been excised and resolved) or colonic dysplasia that has not been completely removed 15. Subject has a history of alcohol or drug abuse within 1 year prior to initiation of Screening 16. Subject has a history of primary nonresponse to 2 or more approved biologic therapies used for the treatment of CD 17. Subject has been treated with a biologic agent within 8 weeks or 5 elimination half-lives (whichever is shorter) prior to the first dose of IP
    1. Soggetti con qualsiasi patologia clinicamente rilevante di tipo epatico, neurologico, polmonare, oftalmologico, endocrino, psichiatrico o altra patologia sistemica importante che possa rendere difficili l’implementazione del protocollo o l’interpretazione dei dati dello studio o possa comportare un rischio per il soggetto in caso di partecipazione.
    2. Soggetti per i quali, secondo la valutazione del medico, è prevedibile la necessità di una resezione intestinale entro 12 settimane dall’ingresso nello studio.
    3. Soggetti con diagnosi di colite ulcerosa, colite indeterminata, colite da radiazioni o colite ischemica o nei quali sia nota la presenza di restringimenti del calibro o stenosi che determinino sintomi di ostruzione.
    4. Soggetti nei quali siano attualmente presenti stomie, anastomosi ileo-anali con pouch, fistole sintomatiche or need for ileostomy or colostomy.o che necessitino di ileostomia o colostomia.
    5. Soggetti sottoposti a massiva resezione del tenue (>100 cm) o diagnosi nota di sindrome da intestino corto oppure soggetti che necessitino di nutrizione parenterale totale.
    6. Soggetti nei quali sussista un sospetto o una diagnosi di ascesso intraddominale o perianale non adeguatamente trattato.
    7. Soggetti con positività documentata al test per Clostridium difficile (C. difficile) con produzione di tossine o a PCR su materiale fecale, in occasione dell’esame svolto più di recente, che deve essere stato eseguito negli ultimi 60 giorni. In caso di positività, i soggetti possono essere trattati e sottoposti a ripetizione del test non prima che siano trascorsi 7 giorni dal completamento del trattamento.
    8. Soggetti con positività documentata al test per la presenza di patogeni (uova, parassiti e batteri), che deve essere stato eseguito negli ultimi 60 giorni. In caso di positività, i soggetti possono essere trattati e sottoposti a ripetizione del test.
    9. Pazienti in stato di gravidanza, in allattamento o nelle quali si sia riscontrato un risultato positivo al test sul siero (frazione beta della gonadotropina corionica umana, ß-hCG) durante lo Screening.
    10. Soggetti con patologie cardiovascolari clinicamente rilevanti, che rendano difficili l’implementazione del protocollo o l’interpretazione dei dati dello studio o che comporterebbero un rischio per il soggetto in caso di partecipazione allo studio, comprese le condizioni attuali o passate riportate di seguito:
    • Episodi recenti (nei 6 mesi precedenti) di infarto miocardico, angina instabile, ictus, attacco ischemico transitorio, scompenso cardiaco che abbia richiesto un ricovero, insufficienza cardiaca di classe III/IV, sindrome del nodo del seno o apnea del sonno grave non trattata.
    • Blocco atrioventricolare (AV) di secondo grado (ad es. Mobitz II), blocco cardiaco di terzo grado, eccetto in pazienti portatori di pacemaker.
    • Intervallo QTcF prolungato (QTcF>450 ms negli uomini, >470 ms nelle donne).
    • Frequenza cardiaca (HR) a riposo <55 bpm, riscontrata durante la rilevazione dei segni vitali nell’ambito dell’esame obiettivo allo Screening.
    11. Diabete mellito di tipo 1 oppure diabete mellito di tipo 2 non controllato con emoglobina A1c (HbA1c) >9% all’anamnesi oppure soggetti diabetici con significative comorbilità quali retinopatia o nefropatia.
    12. Soggetti con uveite all'anamnesi (nell’anno precedente) oppure diagnosi clinicamente confermata di edema maculare.
    13. Soggetti per i quali sia nota la presenza di un’infezione attiva batterica, virale, micotica, da micobatteri o un’infezione di altro tipo (inclusa tubercolosi o malattia da micobatteri atipica [a eccezione di infezioni micotiche del letto ungueale, infezioni minori delle vie aeree superiori, e infezioni cutanee minori]) oppure qualunque episodio infettivo importante che abbia richiesto il ricovero o il trattamento con antibiotici per via endovenosa (EV) nei 30 giorni precedenti lo Screening o antibiotici per via orale nei 14 giorni precedenti lo screening.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with a CDAI score < 150 at Week 12
    Proporzione di soggetti con punteggio CDAI <150 alla Settimana 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Subjects will be deemed a responder with respect to this endpoint if they meet the definition for CDAI Clinical Remission at Week 12.
    I soggetti saranno considerati responders rispetto a questo endpoint se soddisfano la definizione di remissione clinica CDAI alla settimana 12
    E.5.2Secondary end point(s)
    - Proportion of subjects with average daily abdominal pain score <= 1 point, and average daily stool frequency score <= 3 points with abdominal pain and stool frequency no worse than baseline at Week 12
    - Proportion of subjects with a Simple Endoscopic Score for Crohn's Disease (SES CD) score decrease from baseline of >= 50% at Week 12
    - Proportion of subjects with CDAI reduction from baseline of >= 100 points or CDAI score < 150 at Week 12
    - Proportion of subjects with CDAI reduction from baseline of >= 100 points or CDAI score < 150 and SES-CD decrease from baseline of >= 50% at Week 12
    • Proporzione di soggetti con punteggio giornaliero medio sulla scala del dolore addominale <=1 punto e punteggio giornaliero medio relativo alla frequenza di evacuazione <=3 punti e con dolore addominale e punteggio relativo alla frequenza di evacuazione non peggiore rispetto al basale, alla Settimana 12.
    • Proporzione di soggetti con diminuzione del punteggio SES -CD rispetto al basale >=50% alla Settimana 12.
    • Proporzione di soggetti con diminuzione del punteggio CDAI rispetto al basale >=100 punti o punteggio CDAI <150, alla Settimana 12.
    • Proporzione di soggetti con diminuzione del punteggio CDAI rispetto al basale >=100 punti o punteggio CDAI <150 e diminuzione del punteggio SES-CD rispetto al basale >=50%, alla Settimana 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at Week 12
    alla settimana 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic 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 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 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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA104
    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
    Belgium
    Bosnia and Herzegovina
    Brazil
    Bulgaria
    Canada
    China
    Croatia
    Czechia
    Denmark
    Germany
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Moldova, Republic of
    New Zealand
    Norway
    Poland
    Puerto Rico
    Romania
    Russian Federation
    Spain
    Switzerland
    Taiwan
    Turkey
    Ukraine
    United Kingdom
    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
    The end of study is defined as either the date of the last visit of the last subject to complete the safety follow-up, or the date of receipt of the last datapoint from the last subject that is required for primary or secondary analysis, as prespecified in the protocol, whichever is the later date.
    per fine dello studio si intende la data dell'ultima visita dell'ultimo soggetto che completa la visita di sicurezza (follow-up) o la data di ricezione dei dati relativi all'ultimo soggetto richietso per l'analisi primaria o secondaria, come specificato nel protocollo, qualsiasi sia l'ultima data.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 585
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 248
    F.4.2.2In the whole clinical trial 675
    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 will be entering the Maintenance Study or Open-label Extension Study. If not entering these studies they will have a Safety Follow-Up Visit (30 to 90 days after the last dose of IP).
    I soggetti entreranno nello Studio di Mantenimento oppure nello Studio di Estensione in Aperto. Se non entreranno in questi studi, verranno sottoposti a Visite di Follow-Up di Sicurezza (30 e 90 giorni dopo l'ultima dose di farmaco).
    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 Decision2018-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-17
    P. End of Trial
    P.End of Trial StatusOngoing
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