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    Summary
    EudraCT Number:2017-000617-23
    Sponsor's Protocol Code Number:SHP647-307
    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 number2017-000617-23
    A.3Full title of the trial
    A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 307)
    Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli per valutare efficacia e sicurezza di SHP647 come terapia di mantenimento in soggetti con malattia di Crohn da moderata a grave (CARMEN CD 307)
    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 Crohn's Disease, 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.
    Studio di ricerca per valutare se un farmaco sperimentale, SHP647, è sicuro ed efficace nel trattamento della malattia di Crohn 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)
    A.3.2Name or abbreviated title of the trial where available
    CARMEN CD 307
    CARMEN CD 307
    A.4.1Sponsor's protocol code numberSHP647-307
    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 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 pointMelanie Ivarsson
    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 number0016175849253
    B.5.5Fax number0017814822954
    B.5.6E-mailmivarsson0@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 nameSHP647
    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 INNAnti-MAdCAM antibody
    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 nameSHP647
    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 INNAnti-MAdCAM antibody
    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
    Crohn's disease
    Malattia di Crohn
    E.1.1.1Medical condition in easily understood language
    Long-term condition that results in inflammation of the gastrointestinal tract
    Condizione cronica (a lungo termine) che risulta in un'infiammazione del tratto gastrointestinale
    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 LLT
    E.1.2Classification code 10011402
    E.1.2Term Crohn's disease (colon)
    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 coprimary objectives of the study are to evaluate the efficacy of SHP647 as maintenance treatment in subjects with moderate to severe Crohn's Disease (CD) based on:
    -Clinical remission based on 2-item patient-reported outcome (PRO) (abdominal pain severity and very soft stool/liquid stool frequency)
    -Enhanced endoscopic response based on centrally read colonoscopy.
    Gli obiettivi co-primari di questo studio sono la valutazione dell’efficacia di SHP647 come trattamento di mantenimento nei soggetti con malattia di Crohn (CD) da moderata a grave sulla base di:
    • Remissione clinica sulla base degli esiti riferiti dal paziente (PRO) a due voci (gravità del dolore addominale e frequenza di feci liquide/molto morbide)
    • Migliore risposta endoscopica sulla base della lettura centralizzata della colonscopia.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of SHP647 as maintenance treatment:
    -on clinical remission as measured by Crohn's Disease Activity Index (CDAI)
    -on glucocorticoid-free clinical remission based on patient-reported clinical signs and symptoms (as measured by 2-item PRO)
    -on clinical remission based on abdominal pain severity and very soft stool/liquid stool frequency (alternate thresholds)
    -based on achieving clinical remission as well as achieving enhanced endoscopic response in the same subject
    -on complete endoscopic healing.
    To evaluate the efficacy of SHP647 on maintenance:
    -of clinical remission among subjects in clinical remission at baseline of the SHP647-307 study based on patient-reported clinical signs and symptoms (as measured by 2-item PRO)
    -of enhanced endoscopic response among subjects with enhanced endoscopic response at baseline of the SHP647-307 study based on centrally read colonoscopy
    •Valutare l’efficacia di SHP647 come trattamento di mantenimento sulla remissione clinica
    misurata dall’indice CDAI
    libera da glucocorticoidi sulla base dei segni e sintomi clinici
    sulla base della gravità del dolore addominale e frequenza di feci liquide/molto morbide
    •Valutare l’efficacia di SHP647 nel mantenimento
    della remissione clinica in soggetti in remissione al baseline dello studio SHP647-307 sulla base dei segni e sintomi clinici
    del miglioramento della risposta endoscopica nei soggetti con migliore risposta endoscopica al baseline dello studio SHP647-307
    •Valutare l’efficacia di SHP647 come trattamento di mantenimento sulla base del raggiungimento della remissione clinica, nonché il raggiungimento della migliore risposta endoscopica nello stesso soggetto
    •Valutare l’effetto di SHP647 come trattamento di mantenimento sulla guarigione endoscopica completa.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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 have completed the 16-week induction treatment period from study SHP647-305 or SHP647-306 and met the following criteria at baseline in maintenance Study SHP647-307:
    a) Meet endoscopic response criteria of a reduction in SES-CD from induction study (SHP647-305 or SHP647-306) baseline by =25% at Week 16 of induction study (SHP647-305 or SHP647-306)
    OR
    b) Meet at least 1 of the following 4 criteria at baseline in maintenance study SHP647-307, in addition to no worsening of endoscopic score as measured by SES-CD relative to induction study (SHP647-305 or SHP647-306) baseline:
    i. Achieving clinical remission as determined by meeting the criteria for clinical remission using the 2-item PRO, ie, 2-item PRO subscores of average worst daily abdominal pain =3 (based on 11-point numerical rating scale [NRS]) over the 7 most recent days* and average daily stool type frequency =2 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*
    ii. A decrease of at least 100 points in CDAI score (CDAI-100) from induction study (SHP647-305 or SHP647-306) baseline.
    iii. A decrease of =30% and at least 2 points from induction study (SHP647-305 or SHP647-306) baseline in the average daily worst abdominal pain over the 7 most recent days*, with the average daily stool frequency of type 6/7 (very soft stools/liquid stools) either: (i) not worsening from induction study (SHP647-305 or SHP647-306) baseline and/or (ii) meeting the criteria for clinical remission, ie, 2-item PRO subscore of average daily stool frequency =2 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*
    iv. A decrease of =30% from induction study (SHP647-305 or SHP647306) baseline in the average daily stool frequency of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*, with the average daily worst abdominal pain either: (i) not worsening from induction study (SHP647-305 or SHP647-306) baseline and/or (ii) meeting the criteria for clinical remission, ie, 2-item PRO subscore of average worst daily abdominal pain =3 (based on 11-point NRS) over the 7 most recent days* *Note: The 7 days may or may not be contiguous during the 10 days of data collection before colonoscopy preparation, depending on days to be excluded because of missing data. If fewer than 7 days are available, the criterion will be calculated on all available most recent 6 or 5 days. If fewer than 5 days are available, the criterion will be treated as missing.
    4. Subjects receiving any treatment(s) for CD are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
    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 informato e/o assenso alla partecipazione allo studio scritto, firmato e datato (personalmente o da un rappresentante legale autorizzato), come applicabile.
    3. I soggetti devono aver completato il periodo di trattamento di induzione di 16 settimane nello studio SHP647 305 o SHP647 306 e aver soddisfatto i seguenti criteri al baseline nello studio di mantenimento SHP647 307:
    a) soddisfare i criteri di risposta endoscopica di una riduzione del punteggio SES-CD per la malattia di Crohn (Simple Endoscopic Score for Crohn’s Disease) dal baseline dello studio di induzione (SHP647 305 o SHP647 306) del =25% alla Settimana 16 dello studio di induzione (SHP647 305 o SHP647 306)
    OPPURE
    b) soddisfare almeno 1 dei seguenti 4 criteri al baseline dello studio di mantenimento SHP647-307, oltre a nessun peggioramento del punteggio endoscopico misurato da SES-CD relativo al baseline dello studio di induzione (SHP647 305 o SHP647 306):
    i. Ottenere la remissione clinica come stabilito soddisfacendo i criteri per la remissione clinica utilizzando il PRO a 2 voci, ovvero, sottopunteggi del PRO a 2 voci della media del dolore addominale peggiore quotidiano =3 (sulla base della scala numerica di valutazione [NRS] a 11 punti ) negli ultimi 7 giorni* e della media della frequenza defecatoria quotidiana =2 di tipo 6/7 (feci liquide/molto morbide) come mostrato nella BSFS negli ultimi 7 giorni*.
    ii. Una diminuzione di almeno 100 punti nel punteggio CDAI (CDAI-100) dal baseline dello studio di induzione (SHP647 305 o SHP647 306).
    iii. Una diminuzione del =30% e almeno 2 punti dal baseline dello studio di induzione (SHP647 305 o SHP647 306) nella media del dolore addominale peggiore quotidiano negli ultimi 7 giorni*, con media della frequenza defecatoria quotidiana di tipo 6/7 (feci liquide/molto morbide) che: (i) non peggiora dal baseline dello studio di induzione (SHP647 305 o SHP647 306) e/o (ii) soddisfa i criteri di remissione clinica, ossia sottopunteggio del PRO a 2 voci della media della frequenza defecatoria quotidiana =2 di tipo 6/7 (feci liquide/molto morbide) come mostrato nella BSFS negli ultimi 7 giorni*.
    iv. Una diminuzione del =30% dal baseline dello studio di induzione (SHP647 305 o SHP647 306) della media della frequenza defecatoria quotidiana di tipo 6/7 (feci liquide/molto morbide) come mostrato nella BSFS negli ultimi 7 giorni*, con media del dolore addominale peggiore quotidiano che: (i) non peggiora dal baseline dello studio di induzione (SHP647 305 o SHP647 306) e/o (ii) soddisfa i criteri di remissione clinica, ossia sottopunteggio del PRO a due voci della media del dolore addominale peggiore quotidiano =3 (sulla base della NRS a 11 punti ) negli ultimi 7 giorni*.
    *Nota: I 7 giorni potranno essere contigui o meno durante i 10 giorni di raccolta dei dati precedenti la preparazione alla colonscopia, in base ai giorni da escludere a causa di dati mancanti. Se sono disponibili meno di 7 giorni, il criterio sarà calcolato su tutti i 6 o 5 giorni più recenti disponibili. Se sono disponibili meno di 5 giorni, il criterio sarà considerato mancante.
    4. I soggetti che ricevono qualsiasi trattamento(i) per la CD 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.
    E.4Principal exclusion criteria
    1. Subjects who had major protocol deviation(s) (as determined by the sponsor) in induction study SHP647-305 or SHP647-306.
    2. Subjects who permanently discontinued investigational product because of an AE, regardless of relatedness to investigational product, in induction study SHP647-305 or SHP647-306.
    3. Subjects who are likely to require surgery for CD during the study period, except minor interventions (eg, seton placement for anal fistulas).
    4. Subjects are females who became pregnant during induction study SHP647-305 or SHP647-306, females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue using appropriate contraception methods through the conclusion of study participation.
    5. Subjects who do not agree to postpone donation of any organ or tissue, including male subjects who are planning to bank or donate sperm, or female subjects who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
    6. Subjects who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures.
    7. Subjects who have developed obstructive colonic stricture, or enterovesical or enterovaginal fistulae during the induction study (SHP647-305 or SHP647-306).
    8. Subjects who have a newly diagnosed malignancy or recurrence of malignancy (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).
    9. Subjects who have developed any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal [except disease under study], endocrine, cardiovascular, pulmonary, immunologic [eg, Felty's syndrome], or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the subject if he or she participates in the study.
    10. Subjects with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    11. Subjects with known exposure to Mycobacterium tuberculosis since testing at screening in induction study SHP647-305 or SHP647-306 and who have been advised to require treatment for latent or active disease but who are without a generally accepted course of treatment.
    12. Subjects with any of the abnormalities described in the protocol in hematology and/or serum chemistry profiles during the evaluation of the last visit in the SHP647-305 or SHP647-306 studies. If the results are considered by the investigator to be transient and inconsistent with the subject's clinical condition, may be repeated once prior to enrolment in Study SHP647-307.
    13. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are sponsor employees directly involved in the conduct of the study.
    14. Subjects who are participating in other investigational studies (other than induction study SHP647-305 or SHP647-306) or plan to participate in other investigational studies during Study SHP647-307
    1. I soggetti che presentavano deviazione/i rilevante/i dal protocollo (come stabilito dallo Sponsor) nello studio SHP647 305.
    2. I soggetti che hanno interrotto in maniera permanente il prodotto sperimentale a causa di un AE correlato o meno al prodotto sperimentale nello studio SHP647 305.
    3. I soggetti che probabilmente necessiteranno di un intervento chirurgico per la CD durante il periodo dello studio, ad eccezione degli interventi minori
    4. I soggetti di sesso femminile che iniziano una gravidanza durante lo studio di induzione SHP647-305 o SHP647 306, i soggetti di sesso femminile che hanno in programma di iniziare una gravidanza durante il periodo di partecipazione allo studio, o i soggetti di sesso maschile o femminile in età fertile che non accettano di continuare ad utilizzare metodi contraccettivi appropriati fino alla conclusione della partecipazione allo studio.
    5. I soggetti che non accettano di posticipare la donazione di organi o tessuti, inclusi soggetti di sesso maschile che hanno in programma di depositare o donare lo sperma o soggetti di sesso femminile che stanno pianificando di raccogliere o donare ovuli per la durata dello studio e fino a 16 settimane dopo l’assunzione dell’ultima dose di prodotto sperimentale.
    6. I soggetti che, secondo il parere dello sperimentatore o dello sponsor, saranno non collaborativi o incapaci di attenersi alle procedure dello studio.
    7. I soggetti che hanno sviluppato stenosi ostruttiva del colon o fistole enterovescicali o enterovaginali durante lo studio di induzione (SHP647 305 o SHP647-306).
    8. I soggetti con tumore maligno di nuova diagnosi o ricorrenza di tumore maligno (diversi da carcinoma cutaneo rescisso a cellule basali, carcinoma a cellule squamose o carcinoma in situ della cervice uterina che è stato trattato e non presenta evidenza di recidiva).
    9. I soggetti che hanno sviluppato qualsiasi malattia/condizione importante o evidenza di una condizione clinica instabile (ad es., malattia renale, epatica, ematologica, gastrointestinale [ad eccezione della malattia in studio], endocrina, cardiovascolare, polmonare, immunologica [ad es. Sindrome di Felty] o infezione locale attiva/malattia infettiva) che, a giudizio dello Sperimentatore, aumenterebbe in modo significativo il rischio per il soggetto che partecipa allo studio.
    10. I soggetti che presentano qualsiasi condizione psichiatrica o medica cronica o grave in fase acuta o anomalie nei risultati dei test di laboratorio o dell’elettrocardiogramma (ECG) che possano aumentare il rischio associato alla partecipazione allo studio o alla somministrazione del prodotto sperimentale o che possano interferire con l'interpretazione dei risultati dello studio e che, secondo l'opinione dello sperimentatore, renderebbero il soggetto inadeguato all'ingresso in questo studio.
    11. I soggetti con esposizione nota a Mycobacterium tuberculosis (TB) dopo i test effettuati allo screening nello studio di induzione SHP647-305 o SHP647-306 e che sono stati informati in merito alla necessità di ricevere trattamento per malattia latente o attiva, ma che non hanno un ciclo di trattamento generalmente accettato.
    12. I soggetti che presentano una delle anomalie descritte nel protocollo nei profili ematologici e/o chimici del siero durante la valutazione dell'ultima visita negli studi SHP647 305 o SHP647 306. Se i risultati sono considerati dallo Sperimentatore transitori e incompatibili con la condizione clinica del soggetto, potranno essere ripetuti una volta prima dell’arruolamento nello Studio SHP647-307.
    13. I soggetti che sono membri dello staff del centro sperimentale o parenti di tali membri dello staff del centro o i soggetti che sono dipendenti dello Sponsor direttamente coinvolti nella conduzione dello studio.
    14. I soggetti che stanno partecipando ad altri studi sperimentali (diversi dallo studio di induzione SHP647 305 o SHP647 306) o che hanno in programma di partecipare ad altri studi sperimentali durante lo Studio SHP647 307.
    E.5 End points
    E.5.1Primary end point(s)
    Coprimary efficacy endpoints are:
    -Clinical remission as defined by the following: 2- item PRO subscores of average worst daily abdominal pain =3 (based on 11-point NRS) over the 7 most recent days and average daily stool frequency =2 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days. The 7 most recent days may or may not be contiguous during the 10 days of data collection before colonoscopy preparation, depending on days to be excluded because of missing data. If fewer than 7 days are available, the endpoint will be calculated on all available most recent 6 or 5 days. If fewer than 5 days are available, the endpoint will be treated as missing.
    -Enhanced endoscopic response as measured by a decrease in SES-CD of at least 50% from induction study (SHP647-305 or SHP647-306) baseline.
    Gli endpoint di efficacia co-primari sono:
    • Remissione clinica alla visita della Settimana 52 definita da quanto segue: sottopunteggi del PRO a 2 voci della media del dolore addominale peggiore quotidiano =3 (sulla base della NRS a 11 punti) negli ultimi 7 giorni e della media della frequenza defecatoria quotidiana =2 di tipo 6/7 (feci liquide/molto morbide) come mostrato nella BSFS negli ultimi 7 giorni. Gli ultimi 7 giorni potranno essere contigui o meno durante i 10 giorni di raccolta dei dati precedenti la preparazione alla colonscopia, in base ai giorni da escludere a causa di dati mancanti. Se sono disponibili meno di 7 giorni, l’endpoint sarà calcolato su tutti i 6 o 5 giorni più recenti disponibili. Se sono disponibili meno di 5 giorni, l’endpoint sarà considerato mancante.
    • Migliore risposta endoscopica alla Settimana 52 misurata da una diminuzione nel SES-CD di almeno il 50% rispetto al baseline dello studio di induzione (SHP647-305 o SHP647-306).
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 52
    settimana 52
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoints are as follows:
    ¿ Clinical remission at the Week 52 visit as measured by CDAI <150
    ¿ Glucocorticoid-free clinical remission at the Week 52 visit, among subjects using glucocorticoids at induction study baseline. Glucocorticoid-free clinical remission is defined as clinical remission by 2-item PRO (as defined for the coprimary endpoint) in addition to not requiring any treatment with glucocorticoids for at least 12 weeks prior to the Week 52 visit.
    ¿ Clinical remission at the Week 52 visit as defined by the following: CD daily e-diary subscores of average daily abdominal pain =1 (based on the 4-point scale) over the 7 most recent days and average daily stool frequency =3 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days. The 7 most recent days may or may not be contiguous during the 10 days of data collection before colonoscopy preparation, depending on days to be excluded because of missing data. If fewer than 7 days are available, the endpoint will be calculated on all available most recent 6 or 5 days. If fewer than 5 days are available, the endpoint will be treated as missing.
    ¿ Sustained clinical remission, ie, in clinical remission at the SHP647307 Week 52 visit, among subjects who were in clinical remission by 2-item PRO (as defined for the coprimary endpoint) at the time of baseline in Study SHP647-307
    ¿Sustained enhanced endoscopic response, ie, in enhanced endoscopic response at the SHP647-307 Week 52 visit, among subjects who showed enhanced endoscopic response (as defined for the coprimary endpoint) at the time of baseline in Study SHP647-307
    ¿Both clinical remission by 2-item PRO and enhanced endoscopic response at Week 52 (composite endpoint)
    ¿Complete endoscopic healing at Week 52 defined as SES-CD=0-2.
    Gli endpoint di efficacia secondari principali sono i seguenti:
    • Remissione clinica alla visita della Settimana 52 misurata da CDAI <150
    • Remissione clinica libera da glucocorticoidi alla visita della Settimana 52, tra i soggetti che utilizzavano glucocorticoidi al baseline dello studio di induzione. La remissione clinica libera da glucocorticoidi è definita come remissione clinica dal PRO a 2 voci (secondo quanto definito per l’endpoint co-primario), oltre alla non richiesta di alcun trattamento con glucocorticoidi per almeno 12 settimane prima della visita della Settimana 52
    • Remissione clinica alla visita della Settimana 52 definita da quanto segue: sottopunteggi del diario elettronico relativo alla CD da compilare quotidianamente della media del dolore addominale quotidiano =1 (sulla base della scala a 4 punti ) negli ultimi 7 giorni e della media della frequenza defecatoria quotidiana =3 di tipo 6/7 (feci liquide/molto morbide) come mostrato nella BSFS negli ultimi 7 giorni. Gli ultimi 7 giorni potranno essere contigui o meno durante i 10 giorni di raccolta dei dati precedenti la preparazione alla colonscopia, in base ai giorni da escludere a causa di dati mancanti. Se sono disponibili meno di 7 giorni, l’endpoint sarà calcolato su tutti i 6 o 5 giorni più recenti disponibili. Se sono disponibili meno di 5 giorni, l’endpoint sarà considerato mancante.
    • Remissione clinica prolungata, ossia in remissione clinica alla visita della Settimana 52 dello studio SHP647-307, tra i soggetti che erano in remissione clinica in base al PRO a 2 voci (secondo quanto definito per l’endpoint co-primario) al momento del baseline nello Studio SHP647-307
    • Migliore risposta endoscopica prolungata, ossia migliore risposta endoscopica alla visita della Settimana 52 dello studio SHP647 307, tra i soggetti che avevano mostrato migliore risposta endoscopica (secondo quanto definito per l’endpoint co-primario) al momento del baseline nello Studio SHP647-307
    • Remissione clinica in base al PRO a 2 voci e risposta endoscopica migliore alla Settimana 52 (endpoint composito)
    • Guarigione endoscopica completa alla Settimana 52 definita da SES-CD=0-2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 52
    settimana 52
    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
    Qualità 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 No
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA172
    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
    Austria
    Belgium
    Bosnia and Herzegovina
    Brazil
    Bulgaria
    Canada
    Colombia
    Croatia
    Czechia
    Estonia
    Germany
    Greece
    Hungary
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Lithuania
    Mexico
    Netherlands
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Switzerland
    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 Study Completion Date is defined as the date the final subject, across all sites, completes their final protocol-defined assessment.This includes the follow-up visit or contact, whichever is later.
    La data di conclusione dello studio è 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 years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 98
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 866
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 19
    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 state95
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 499
    F.4.2.2In the whole clinical trial 983
    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 treatment period (Week 52), the subject will either enter the long-term study (Study SHP647-304) if eligible, or the 16 week safety follow-up period with the SoC at investigator' discretion.
    Al termine del periodo di trattamento (52 settimane) i soggetti entreranno nello studio di estensione (long-term study SHP647-304), se eleggibili, oppure completeranno il periodo di follow up di 16 settimane con la terapia standard (SoC) a discrezione dello Sperimentatore.
    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 Decision2019-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-09-13
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