Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42517   clinical trials with a EudraCT protocol, of which   7000   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-000599-27
    Sponsor's Protocol Code Number:SHP647-301
    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:2021-01-22
    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 number2017-000599-27
    A.3Full title of the trial
    A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with
    Moderate to Severe Ulcerative Colitis (FIGARO UC 301)
    Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli per valutare efficacia e sicurezza di SHP647 come terapia di induzione in soggetti con colite ulcerosa da moderata a grave (FIGARO UC 301)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis,
    compared with placebo (dummy treatment) ¿ using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).
    Studio di ricerca per valutare se un farmaco sperimentale, SHP647, ¿ sicuro ed efficace nel trattamento della colite ulcerosa da moderata a grave, rispetto al placebo (trattamento fittizio) - usando un disegno di studio randomizzato ed in cieco (sperimentatore e pazienti non sanno se ricevono il farmaco in studio o il placebo) (FIGARO UC 301)
    A.3.2Name or abbreviated title of the trial where available
    FIGARO UC 301
    FIGARO UC 301
    A.4.1Sponsor's protocol code numberSHP647-301
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03259334
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/281/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSHIRE HUMAN GENETIC THERAPIES, INC
    B.1.3.4CountryUnited States
    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 supportShire Human Genetic Therapies, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShire Human Genetic Therapies, Inc.
    B.5.2Functional name of contact pointChantal L. Letourneau
    B.5.3 Address:
    B.5.3.1Street Address300 Shire Way
    B.5.3.2Town/ cityLexington
    B.5.3.3Post codeMA 02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number0017814820852
    B.5.5Fax number000000000
    B.5.6E-mailchantal.letourneau@shire.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 name-
    D.3.2Product code [SHP647]
    D.3.4Pharmaceutical form Solution for injection
    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 INNontamalimab
    D.3.9.2Current sponsor codeSHP647
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 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 name-
    D.3.2Product code [SHP647]
    D.3.4Pharmaceutical form Solution for injection
    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 INNontamalimab
    D.3.9.2Current sponsor codeSHP647
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous 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
    Long-term condition that results in inflammation and ulcers of the colon and rectum
    Malattia cronica che porta ad infiammazione ed ulcere del colon e del retto
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    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 of the study is to evaluate the efficacy of ontamalimab in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).
    Valutare l¿efficacia di ontamalimab sull¿induzione della remissione in soggetti con colite ulcerosa (CU) da moderata a grave, sulla base del punteggio composito dei sintomi riferiti dal paziente e della lettura centralizzata dell¿endoscopia.
    E.2.2Secondary objectives of the trial
    ¿ To evaluate the efficacy of ontamalimab in achieving endoscopic remission, based on centrally read endoscopy.
    ¿ To evaluate the efficacy of ontamalimab in achieving clinical remission, based on composite score of patient-reported symptoms.
    ¿ To evaluate the efficacy of ontamalimab in inducing clinical response, based on composite score of patient-reported symptoms and centrally read
    endoscopy.
    ¿ To evaluate the efficacy of ontamalimab in achieving mucosal healing, based on endoscopic and histological assessment using the Geboes Score grading system.
    ¿ Valutare l¿efficacia di ontamalimab sul raggiungimento della remissione endoscopica, sulla base della lettura centralizzata dell¿endoscopia.
    ¿ Valutare l¿efficacia di ontamalimab sul raggiungimento della remissione clinica, sulla base del punteggio composito dei sintomi riferiti dal paziente.
    ¿ Valutare l¿efficacia di ontamalimab sull¿induzione della risposta clinica, sulla base del punteggio composito dei sintomi riferiti dal paziente e della lettura centralizzata dell¿endoscopia.
    ¿ Valutare l¿efficacia di ontamalimab sul raggiungimento della guarigione della mucosa, sulla base della valutazione istologica ed endoscopica utilizzando la scala di misurazione Geboes Score.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study.
    1. Subjects and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
    2. Subjects must be able to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent and/or assent, as applicable, to participate in the study.
    3. Subjects must be between =16 and =80 years of age at the time of the signing of the informed consent/assent form.
    NOTE: Subjects <18 years of age must weigh =40 kg and must have body mass index (BMI) =16.5 kg/m2
    4. Subjects must have a documented diagnosis (radiologic or endoscopic with histology) of UC for =3 months before screening. The following must be available in each subject’s source documentation:
    • A biopsy report to confirm the histological diagnosis.
    • A report documenting disease duration based upon prior colonoscopy.
    NOTE: If this documentation is not available at the time of screening, a colonoscopy with biopsy to confirm the diagnosis is required during the screening period.
    5. Subjects must be willing to undergo a flexible sigmoidoscopy or colonoscopy (if preferred), including biopsy sample collection, during screening after all other inclusion criteria have been met.
    6. Subjects must have moderate to severe active UC, defined as a total Mayo score of =6, including a centrally read endoscopic subscore =2, rectal bleeding subscore =1, and stool frequency subscore =1 at baseline (Visit 2).
    7. Subjects must have evidence of UC extending proximal to the rectum (ie, not limited to proctitis).
    8. Subjects must have had an inadequate response to, or lost response to, or had an intolerance to,at least 1 conventional treatment such as mesalamine (5 aminosalicylic acid [5-ASA]), glucocorticoids, immunosuppressants (azathioprine [AZA], 6 mercaptopurine [6 MP], or methotrexate [MTX]), or anti-TNF.
    9. Subjects receiving any treatment(s) for UC described in Section 5.2.1 of the protocol are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
    10. Subjects are males or nonpregnant, nonlactating females who, if sexually active, agree to comply with the contraceptive requirements of the protocol, or females of nonchildbearing potential. Males and females of reproductive potential who are sexually active must agree to use appropriate contraception (ie, highly effective methods for female and medically appropriate methods for male study subjects) (as described in Section 4.4 of the protocol) for the duration of the study.
    Per essere eleggibili all'arruolamento nello studio, i soggetti dovranno soddisfare tutti i criteri di inclusione descritti di seguito.
    1. I soggetti e/o i loro genitori o rappresentante legale autorizzato devono possedere cognizioni, capacità e volontà di aderire integralmente alle procedure e alle restrizioni imposte dallo studio.
    2. I soggetti devono essere in grado di fornire volontariamente il proprio consenso e/o assenso informato alla partecipazione allo studio scritto, firmato e datato (personalmente o da un rappresentante legale autorizzato), come applicabile.
    3. I soggetti devono avere un’età compresa tra =16 e =80 anni al momento della firma del modulo di consenso/assenso informato.
    NOTA: I soggetti con età <18 anni devono pesare =40 kg e devono avere un indice di massa corporea (BMI) =16,5 kg/m2
    4. I soggetti devono presentare diagnosi documentata (radiologica o endoscopica con istologia) di CU da =3 mesi prima dello screening. I seguenti documenti devono essere disponibili nella documentazione originale (source documentation) di ciascun soggetto:
    • Un referto della biopsia a conferma della diagnosi istologica.
    • Un referto che documenti la durata della malattia sulla base di una colonscopia precedente.
    NOTA: Se tale documentazione non è disponibile al momento dello screening, durante il periodo di screening è necessario eseguire una colonscopia con biopsia a conferma della diagnosi.
    5. I soggetti devono essere disposti a sottoporsi a sigmoidoscopia o colonscopia flessibile (se preferito), inclusa la raccolta di campioni mediante biopsia, durante lo screening dopo il soddisfacimento di tutti i criteri di inclusione.
    6. I soggetti devono essere affetti da CU da moderata a grave, definita da un punteggio Mayo totale =6, incluso un sottopunteggio =2 della lettura centralizzata dell’endoscopia, un sottopunteggio =1 per il sanguinamento rettale e un sottopunteggio =1 per la frequenza delle feci al baseline (Visita 2).
    7. I soggetti devono presentare evidenza di CU che si estende in prossimità del retto (non limitata alla proctite).
    8. I soggetti devono aver avuto una risposta inadeguata o una mancata risposta o una intolleranza ad almeno 1 trattamento convenzionale quale ad esempio mesalazina (acido 5-amminosalicilico [5-ASA]), glucocorticoidi, immunosoppressori (azatioprina [AZA], 6-mercaptopurina [6MP], o metotrexato [MTX]), o anti-TNF.
    9. I soggetti che ricevono qualsiasi trattamento(i) per la CU descritto nella Sezione 5.2.1 del protocollo sono eleggibili a condizione che siano stati, o sia previsto che siano, in trattamento con una dose stabile per il periodo di tempo stabilito.
    10. I soggetti devono essere di sesso maschile oppure di sesso femminile non in stato di gravidanza o allattamento che, se sessualmente attivi, accettano di aderire ai requisiti di contraccezione previsti dal protocollo, oppure soggetti di sesso femminile non fertili. I soggetti di sesso maschile e femminile fertili e sessualmente attivi devono accettare di utilizzare forme di contraccezione appropriati (ovvero metodi altamente efficaci per i soggetti di sesso femminile e metodi clinicamente appropriati per i soggetti di sesso maschile) (come descritto nella Sezione 4.4. del protocollo) per l’intera durata dello studio.
    E.4Principal exclusion criteria
    1. Subjects with indeterminate colitis, microscopic colitis, non-steroidal anti-inflammatory drug-induced colitis, ischemic colitis, infectious colitis, or clinical/histologic findings suggestive of Crohn’s disease.
    2. Subjects with colonic dysplasia or neoplasia.
    3. Subjects with past medical history or presence of toxic megacolon.
    4. Subjects with colonic stricture, past medical history of colonic resection, a history of bowel surgery within 6 months before screening, or who are likely to require surgery for UC during the treatment period.
    5. Subjects at risk for colorectal cancer must have a colonoscopy performed during the screening period with results available within 10 days before the baseline visit (Visit 2), unless the subject has had a surveillance colonoscopy performed within 1 year prior to screening, and any adenomatous polyps found at that examination have been excised. Colonoscopy report and pathology report from the colonoscopy performed during screening or in the prior year confirming no evidence of dysplasia and colon cancer must be available in the source documents.
    Subjects at risk for colorectal cancer include, but are not limited to:
    • Subjects with extensive colitis for =8 years or disease limited to left side of colon (ie, distal to splenic flexure) for =10 years before screening, regardless of age.
    • Subjects =50 years of age at the time of signing of the informed consent form.
    6. Subjects have had prior treatment with ontamalimab (SHP647)
    7. Subjects with known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients.
    8. Subjects have received anti-TNF treatment within 60 days before baseline (Visit 2).
    9. Subjects have received any biologic with immunomodulatory properties (other than anti TNFs) within 90 days before baseline (Visit 2).
    10. Subjects have received any nonbiologic treatment with immunomodulatory properties (other than their current background UC treatment) within 30 days before baseline (Visit 2).
    11. Subjects have ever received anti-integrin/adhesion molecule treatment (eg, natalizumab, vedolizumab, efalizumab, etrolizumab, or any other investigational anti-integrin/adhesion molecule).
    12. Subjects have received parenteral or rectal glucocorticoids, or rectal 5-ASA, within 14 days before screening endoscopic procedure.
    13. Subjects have received leukocyte apheresis or selective lymphocyte, monocyte, or granulocyte apheresis or plasma exchange within 30 days before baseline (Visit 2).
    14. Subjects have participated in other investigational studies within either 30 days or 5 half lives of investigational product used in the study (whichever is longer) before baseline (Visit 2).
    15. Subjects have received a live (attenuated) vaccine within 30 days before the baseline visit (Visit 2).
    16. Subjects with active enteric infections (positive stool culture and sensitivity), Clostridium difficile infection or pseudomembranous colitis [subjects with C. difficile infection at screening may be allowed re-test after treatment], evidence of active cytomegalovirus infection or Listeria monocytogenes, known active invasive fungal infections such as histoplasmosis or parasitic infections, clinically significant underlying disease that could predispose the subjects to infections, or a history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks before the baseline visit (Visit 2).
    17. Subjects with abnormal chest x-ray findings at screening (Visit 1), such as presence of active tuberculosis (TB), general infections, heart failure, or malignancy.
    18. Subjects with evidence of active or latent infection with Mycobacterium tuberculosis (TB) or subjects with this history who have not completed a generally accepted full course of treatment before randomization are excluded. All other subjects must have either the Mantoux tuberculin skin test or IGRA performed.
    I soggetti con:
    1. colite indeterminata, colite microscopica, colite indotta da farmaci anti-infiammatori non steroidei, colite ischemica, colite infettiva o risultati clinici/istologici indicativi di malattia di Crohn.
    2. displasia o neoplasia del colon.
    3. anamnesi medica precedente o presenza di megacolon tossico.
    4. stenosi del colon, anamnesi medica precedente di resezione del colon, anamnesi di intervento chirurgico all’intestino nei 6 mesi precedenti lo screening, o che probabilmente necessiteranno di un intervento chirurgico per la CU durante il periodo di trattamento.
    5. I soggetti a rischio di sviluppare carcinoma del colon-retto devono presentare una colonscopia eseguita durante il periodo di screening con risultati disponibili entro 10 giorni prima della visita basale, a meno che il soggetto non si sia stato sottoposto a colonscopia di controllo eseguita nell’anno precedente lo screening ed eventuali polipi adenomatosi rilevati in occasione di tale esame siano stati asportati. Il referto della colonscopia e il referto di patologia ottenuti dalla colonscopia eseguita durante lo screening o nell’anno precedente che confermano che non ci sono evidenze di displasia e carcinoma del colon devono essere inseriti nella documentazione originale
    I soggetti a rischio di sviluppare carcinoma del colon-retto includono, a titolo esemplificativo:
    • I soggetti con colite estesa da =8 anni oppure malattia limitata al lato sinistro del colon da =10 anni prima dello screening, indipendentemente dall’età.
    • I soggetti con età = 50 anni al momento della firma del modulo di consenso informato.
    6. I soggetti che hanno ricevuto precedente trattamento con ontamalimab (precedentemente SHP647)
    7. I soggetti con intolleranza o ipersensibilità note o sospette al prodotto sperimentale, ai composti strettamente correlati o a qualsiasi dei componenti dichiarati.
    8. I soggetti che hanno ricevuto trattamento con anti-TNF nei 60 giorni precedenti il baseline
    9. soggetti che hanno ricevuto qualsiasi agente biologico con proprietà immunomodulatorie nei 90 giorni precedenti il baseline
    10. soggetti che hanno ricevuto qualsiasi trattamento non biologico con proprietà immunomodulatorie nei 30 giorni precedenti la baseline
    11. soggetti che abbiano ricevuto in un qualunque momento trattamento con molecola anti-integrina che agisce sull’adesione
    12. soggetti che hanno ricevuto glucocorticoidi per via parenterale o rettale, o 5-ASA per via rettale, nei 14 giorni precedenti la procedura endoscopica allo screening.
    13. soggetti che hanno ricevuto leucocito-aferesi o linfocito, monocito o granulocito-aferesi selettiva o plasmaferesi nei 30 giorni precedenti la baseline
    14. soggetti che hanno partecipato ad altri studi sperimentali nei 30 giorni o nelle 5 emivite del prodotto sperimentale che viene utilizzato nello studio precedenti il baseline
    15. soggetti che hanno ricevuto un vaccino vivo (attenuato) nei 30 giorni precedenti la visita di baseline
    16. soggetti con infezioni enteriche attive, infezione da Clostridium difficile o colite pseudomembranosa, evidenza di infezione attiva da citomegalovirus o da Listeria monocytogenes, note infezioni fungine invasive attive quali istoplasmosi o infezioni parassitarie, malattia preesistente clinicamente significativa che potrebbe predisporre il soggetto a contrarre infezioni, o anamnesi di infezione seria nelle 4 settimane precedenti la visita di baseline
    17. soggetti che presentano risultati anomali della radiografia del torace allo screening quali presenza di tubercolosi attiva, infezioni generiche, insufficienza cardiaca o tumori maligni.
    18. Sono esclusi i soggetti che presentano evidenza di infezione attiva o latente da Mycobacterium tuberculosis o soggetti con questa anamnesi che non hanno completato un intero ciclo di trattamento generalmente accettato prima della randomizzazione. Tutti gli altri soggetti devono essersi sottoposti al test cutaneo di Mantoux per la tubercolina o al test IGRA.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of subjects in remission at the Week 12 visit. Remission is defined as a composite score of
    patient-reported symptoms using daily e-diary and centrally read
    endoscopy as follows:
    • stool frequency subscore of 0 or 1 with at least a 1-point change from baseline
    AND
    • rectal bleeding subscore of 0
    AND
    • endoscopic subscore of 0 or 1 (modified, excludes friability).
    L'endpoint di efficacia primario è la percentuale di soggetti in remissione alla visita della Settimana 12. La remissione è definita da un punteggio composito dei sintomi riferiti dal paziente mediante la compilazione giornaliera del diario elettronico e della lettura centralizzata dell’endoscopia come segue:
    • sottopunteggio di frequenza delle feci di 0 o 1 con variazione di almeno 1 punto rispetto al baseline
    E
    • sottopunteggio per il sanguinamento rettale di 0
    E
    • sottopunteggio endoscopico di 0 o 1 (modificato, esclude la friabilità).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12 visit
    Visita della settimana 12
    E.5.2Secondary end point(s)
    ¿endoscopic remission, as defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability), at the Week 12 visit.
    ¿ clinical remission, as defined by stool frequency subscore of 0 or 1 with at least a 1-point change from baseline in stool frequency subscore, and rectal bleeding subscore of 0, at the Week 12 visit.
    ¿ clinical response based on composite score at the Week 12 visit. Clinical response (composite) is defined as a decrease from baseline in the composite score of patient-reported
    symptoms using daily-e diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the subscore
    for rectal bleeding =1 point or a subscore for rectal bleeding =1.
    ¿ mucosal healing based on endoscopic and histological assessment at the Week 12 visit. Mucosal healing is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability) and centrally read Geboes score of =2.
    ¿ remissione endoscopica, definita da un sottopunteggio di 0 o 1 (modificato, esclude la friabilit¿) della lettura centralizzata dell¿endoscopia, alla visita della Settimana 12.
    ¿ P remissione clinica, definita da un sottopunteggio di frequenza delle feci di 0 o 1 con variazione di almeno 1 punto rispetto al baseline nel sottopunteggio di frequenza delle feci, e sottopunteggio per il sanguinamento rettale di 0, alla visita della Settimana 12.
    ¿ risposta clinica sulla base del punteggio composito alla visita della Settimana 12. La risposta clinica (composita) ¿ definita come diminuzione rispetto al baseline del punteggio composito dei sintomi riferiti dal paziente mediante la compilazione giornaliera del diario elettronico e della lettura centralizzata dell¿endoscopia di almeno 2 punti e almeno il 30%, con una diminuzione associata del sottopunteggio per il sanguinamento rettale di =1 punto o un sottopunteggio per il sanguinamento rettale di =1.
    ¿ guarigione della mucosa sulla base della valutazione endoscopica e istologica alla visita della Settimana 12. La guarigione della mucosa ¿ definita da un sottopunteggio di 0 o 1 (modificato, esclude la friabilit¿) della lettura centralizzata dell¿endoscopia e un punteggio Geboes di =2 della lettura centralizzata.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12 visit
    Visita della 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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    Qualit¿ della vita
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    ontamalimab 25mg o 75 mg
    25mg o 75mg ontamalimab
    E.8.2.4Number of treatment arms in the trial3
    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 concerned19
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA111
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Brazil
    Croatia
    Czechia
    Germany
    Greece
    Israel
    Italy
    Japan
    Lithuania
    Netherlands
    New Zealand
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    Slovenia
    South Africa
    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 Study Completion Date is defined as the date the final subject, across all sites, completes their final protocol-defined assessment.
    Please note that this includes the follow-up visit or contact, whichever is later.
    La data di conclusione dello studio ¿ definita come la data in cui l'ultimo soggetto di tutti i centi clinici completa la valutazione finale definita dal protocollo.
    Si prega di notare che questo include la visita o il contatto di follow-up, qualunque sia quello che avviene per ultimo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days19
    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: 82
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 726
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Adolescents (16-17 years)
    Adolescenti (16-17 anni)
    F.4 Planned number of subjects to be included
    F.4.1In the member state115
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 395
    F.4.2.2In the whole clinical trial 825
    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)
    At the end of the 12 week treatment period, eligible subjects will be offered the opportunity to participate in a double-blind maintenance study (SHP647-303; for subjects who achieve clinical response) or a
    long-term safety extension (LTS) study SHP647-304; for subjects who do not achieve a clinical response).
    Al termine del periodo di trattamento di 12 settimane, ai soggetti eleggibili sar¿ offerta l¿opportunit¿ di partecipare a uno studio di mantenimento in doppio cieco (SHP647-303; per i soggetti che raggiungono una risposta clinica) o a uno studio di estensione per valutare la sicurezza a lungo termine (LTS - Long-Term Safety) (SHP647-304; per i soggetti che non raggiungono una risposta clinica).
    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 Decision2018-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-23
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA