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    Summary
    EudraCT Number:2017-000573-37
    Sponsor's Protocol Code Number:SHP647-303
    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 number2017-000573-37
    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 Ulcerative Colitis (FIGARO UC 303)
    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 colite ulcerosa da moderata a grave (FIGARO UC 303)
    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 303).
    Studio di ricerca per determinare se un farmaco sperimentale, SHP647, ¿ sicuro ed efficace nel trattamento della Colite Ulcerosa da moderata a grave, a confronto del placebo (trattamento privo del principio attivo) - utilizzando un disegno di studio randomizzato e in cieco (gli sperimentatori e i pazienti non sanno se ricevono il farmaco in studio o il placebo) (FIGARO UC 303).
    A.3.2Name or abbreviated title of the trial where available
    FIGARO UC 303
    FIGARO UC 303
    A.4.1Sponsor's protocol code numberSHP647-303
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03290781
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    A.5.4Other Identifiers
    Name:-Number:-
    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 number0000000000
    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
    Condizione a lungo termine che provoca infiammazione e ulcere nel colon e nel 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
    as maintenance treatment of remission, based on composite score of
    patient reported symptoms and centrally read endoscopy, in subjects
    with moderate to severe UC.
    Valutare l¿efficacia di ontamalimab come trattamento di mantenimento sulla 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
    The key secondary objectives of the study are as follows:
    ¿ To evaluate the efficacy of ontamalimab on endoscopic remission, based on centrally read endoscopy.
    ¿ To evaluate the efficacy of ontamalimab on clinical remission, based on composite score of patient-reported symptoms.
    ¿ To evaluate the efficacy of ontamalimab on maintenance of remission among subjects in remission at baseline of the SHP647-303 study, based on composite score of patient-reported symptoms and centrally read endoscopy.
    ¿ To evaluate the efficacy of ontamalimab on clinical response, based on composite score of patient-reported symptoms and centrally read endoscopy.
    ¿ To evaluate the efficacy of ontamalimab on mucosal healing, based on a centrally read on endoscopic and histological assessments using the Geboes Score grading system.
    ¿ To evaluate the efficacy of ontamalimab on glucocorticoid free clinical remission.
    ¿ To evaluate the efficacy of ontamalimab on glucocorticoid free remission.
    Obiettivi Secondari principali:
    Valutare l¿efficacia di ontamalimab
    -sulla remissione endoscopica, sulla base della lettura centralizzata dell¿endoscopia.
    -sulla remissione clinica, sulla base del punteggio composito dei sintomi riferiti dal paziente.
    -sul mantenimento della remissione in soggetti in remissione alla baseline dello studio SHP647-303, sulla base del punteggio composito dei sintomi riferiti dal paziente e della lettura centralizzata dell¿endoscopia.
    -sulla risposta clinica, sulla base del punteggio composito dei sintomi riferiti dal paziente e della lettura centralizzata dell¿endoscopia.
    -sulla guarigione della mucosa, sulla base delle valutazioni istologiche ed endoscopiche lette a livello centrale, usando il sistema di classificazione del punteggio Geboes.
    -sulla remissione clinica libera da glucocorticoidi.
    -sulla remissione libera da glucocorticoidi.
    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 have completed the 12 week induction treatment
    period from study SHP647 301 or SHP647-302.
    4. Subjects must have achieved clinical response in induction study
    SHP647-301 or SHP647 302. Clinical response is defined as:
    1) A decrease from the induction study (SHP647 301 or SHP647-302)
    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
    OR
    2) A decrease from the induction study (SHP647 301 or SHP647-302)
    baseline in total Mayo score of at least 3 points and at least 30%, with
    an accompanying decrease in the rectal bleeding subscore of at least 1
    point or an absolute rectal bleeding subscore of 0 or 1.
    For eligibility assessment, clinical response will be determined based on
    the centrally read endoscopy performed during screening and at Week
    12 of induction study SHP647 301 or SHP647 302.
    5. Subjects receiving any treatment(s) for UC described in Section 5.2.1
    are eligible provided they have been, and are anticipated to be, on a
    stable dose for the designated period of time.
    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).
    3. I soggetti devono aver completato il periodo di trattamento di induzione di 12 settimane nello studio SHP647-301 o SHP647-302.
    4. I soggetti devono aver raggiunto risposta clinica nello studio di induzione SHP647-301 o SHP647-302. La risposta clinica è definita come:
    1) Una diminuzione rispetto al baseline del punteggio composito dei sintomi riferiti dal paziente mediante la compilazione giornaliera del diario elettronico e la 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 =1
    OPPURE
    2) Una diminuzione del punteggio Mayo totale rispetto al baseline dello studio di induzione (SHP647-301 o SHP647-302) di almeno 3 punti e almeno il 30%, con una diminuzione associata del sottopunteggio per il sanguinamento rettale di almeno 1 punto o un sottopunteggio assoluto per il sanguinamento rettale di 0 o 1.
    Per la valutazione dell’eleggibilità, la risposta clinica sarà stabilita sulla base della lettura centralizzata dell’endoscopia eseguita durante lo screening e alla Settimana 12 dello studio di induzione SHP647-301 o SHP647-302.
    5. I soggetti che ricevono qualsiasi trattamento 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.
    E.4Principal exclusion criteria
    Subjects are excluded from the study if any of the following exclusion
    criteria are met:
    1. Subjects who had major protocol deviation(s) (as determined by the
    sponsor) in induction study SHP647 301 or SHP647 302.
    2. Subjects who permanently discontinued investigational product
    because of an adverse event (AE), regardless of relatedness to investigational product, in
    induction study SHP647-301 or SHP647-302.
    3. Subjects who are likely to require surgery for UC during the study
    period.
    4. Subjects are females who became pregnant during induction study
    SHP647-301 or SHP647 302, females who are planning to become
    pregnant during the study period, or males or females of childbearing
    potential not agreeing to continue acceptable contraception methods (ie, highly effective methods for female and medically appropriate methods for male study subjects)
    through the conclusion of study participation (see Section 4.4).
    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, and 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 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).
    8. 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.
    9. Subjects with any other severe acute or chronic medical or psychiatric
    condition or laboratory or 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.
    10. Subjects with known exposure to Mycobacterium tuberculosis (TB)
    since testing at screening in induction study SHP647-301 or SHP647-302
    and who are without a generally accepted course of treatment.
    11. 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.
    12. Subjects who are participating in or plan to participate in other
    investigational studies (other than induction study SHP647-301 or
    SHP647 302) during study SHP647-303.
    I soggetti sono esclusi dallo studio se soddisfano uno dei seguenti criteri:
    1. I soggetti che presentavano deviazione/i rilevante/i dal protocollo (come stabilito dallo Sponsor) nello studio di induzione SHP647-301 o SHP647-302.
    2. I soggetti che hanno interrotto in maniera permanente il prodotto sperimentale a causa di un evento avverso (AE) collegato o meno al prodotto sperimentale, nello studio di induzione SHP647-301 o SHP647-302.
    3. I soggetti che probabilmente necessiteranno di un intervento chirurgico per la CU durante il periodo dello studio.
    4. I soggetti di sesso femminile che iniziano una gravidanza durante lo studio di induzione SHP647-301 o SHP647-302, 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 (ovvero, metodi altamente efficaci per i soggetti dello studio di sesso femminile e metodi appropriati a livello medico per i soggetti dello studio di sesso maschile) fino alla conclusione della partecipazione allo studio.
    5. I soggetti che non accettano di posticipare la donazione di organi o tessuti, inclusio i soggetti di sesso maschile che hanno in programma di depositare o donare lo sperma e i soggetti di sesso femminile che stanno pianificando di raccogliere o donare ovuli devono accettare di non farloper 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 con tumore maligno di nuova diagnosi o con recidive di tumore maligno (diversi da carcinoma cutaneo a cellule basali rescisso, a cellule squamose o carcinoma in situ della cervice uterina che è stato trattato e non presenta evidenza di recidiva).
    8. 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.
    9. I soggetti che presentano qualsiasi condizione psichiatrica o medica grave cronica o 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.
    10. I soggetti con esposizione nota a Mycobacterium tuberculosis (TB) dopo i test effettuati allo screening nello studio di induzione SHP647-301 o SHP647-302 e che sono senza un ciclo di trattamento generalmente accettato.
    11. 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.
    12. I soggetti che stanno partecipando o hanno in programma di partecipare ad altri studi sperimentali (diversi dallo studio di induzione SHP647-301 o SHP647-302) durante lo studio SHP647-303.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is proportion of subjects in remission at
    the Week 52 visit. Remission is defined as a composite score of patientreported
    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
    induction
    (SHP647 301 or SHP647 302) 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 52. La remissione è definita da un punteggio composito dei sintomi riferiti dal paziente mediante la compilazione giornaliera del diario elettronico e la lettura centralizzata dell’endoscopia come segue:
    • sottopunteggio di frequenza delle feci di 0 o 1 con variazione di almeno 1 punto rispetto al baseline dello studio di induzione (SHP647-301 o SHP647-302)
    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 52 visit
    visita alla settimana 52
    E.5.2Secondary end point(s)
    ¿ Proportion of subjects with endoscopic remission, as defined by
    centrally read endoscopic subscore 0 or 1 (modified, excludes friability),
    at the Week 52 visit.
    ; Proportion of subjects with clinical remission as defined by stool
    frequency subscore of 0 or 1 with at least a 1-point change from
    induction study (SHP647-301 or SHP647-302) baseline in stool
    frequency subscore, and rectal bleeding subscore of 0, at the Week 52
    visit.
    ; Proportion of subjects with sustained remission, ie, in remission at the
    SHP647-303 Week 52 visit, among subjects who were in remission at the
    time of baseline in study SHP647 303. Remission is defined as a
    composite score of patient-reported symptoms using daily e-diary and
    centrally read endoscopy, with stool frequency subscore of 0 or 1 with at
    least a 1-point change from induction study (SHP647-301 or SHP647302)
    baseline, and rectal bleeding subscore of 0, and endoscopic
    subscore
    of 0 or 1 (modified, excludes friability).
    ; Proportion of subjects with clinical response based on composite score
    at the Week 52 visit. Clinical response (composite) is defined as a
    decrease from induction study (SHP647-301 or SHP647 302) baseline in
    the composite score of subject-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. ; Proportion of subjects with mucosal healing, based on endoscopic and
    histologic assessment, at the Week 52 visit. Mucosal healing is defined
    by centrally read endoscopic subscore 0 or 1 (modified, excludes
    friability) and centrally read Geboes score of =2.
    ; Proportion of subjects achieving glucocorticoid-free clinical remission
    at Week 52, among subjects using glucocorticoids in study SHP647-303
    baseline. Glucocorticoid-free clinical remission is defined as clinical
    remission in addition to not requiring any treatment with glucocorticoids
    for at least 4 weeks prior to the Week 52 visit. Clinical remission is
    defined as stool frequency subscore of 0 or 1 with at least a 1-point
    change from induction study (SHP647-301 or SHP647-302) baseline in
    stool frequency subscore, and rectal bleeding subscore of 0, at the Week
    52 visit.
    ; Proportion of subjects achieving glucocorticoid-free remission at Week
    52, among subjects using glucocorticoids in study SHP647-303 baseline.
    Glucocorticoid-free remission is defined as remission in addition to not
    requiring any treatment with glucocorticoids for at least 4 weeks prior to
    the Week 52 visit. Remission is defined as a composite score of subjectreported
    symptoms using daily e diary and endoscopy, with stool
    frequency
    subscore of 0 or 1 with at least a 1-point change from
    induction
    study (SHP647-301 or SHP647-302) baseline, and rectal
    bleeding
    subscore of 0, and endoscopic subscore of 0 or 1 (modified,
    excludes
    friability).
    ¿ Percentuale di soggetti che presentano remissione endoscopica, definita da un sottopunteggio endoscopico letto centralmente di 0 o 1 (modificato, esclude la friabilit¿), alla visita della Settimana 52.; ¿ Percentuale di soggetti che presentano 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 nello studio di induzione (SHP647-301 o SHP647-302), e sottopunteggio per il sanguinamento rettale di 0, alla visita della Settimana 52.; ¿ Percentuale di soggetti con remissione prolungata, ovvero in remissione alla visita della settimana 52 dello studio SHP647-303, tra i soggetti che erano in remissione al momento del baseline dello studio SHP647-303. La remissione ¿ definita come un punteggio composito dei sintomi riferiti dal paziente mediante la compilazione giornaliera del diario elettronico e la lettura centralizzata dell¿endoscopia, con il sottopunteggio di frequenza delle feci di 0 o 1 con variazione di almeno 1 punto rispetto al baseline dello studio di induzione (SHP647-301 o SHP647-302), il sottopunteggio per il sanguinamento rettale di 0, e il sottopunteggio endoscopico di 0 o 1 (modificato, esclude la friabilit¿).
    ; ¿ Percentuale di soggetti che presentano risposta clinica sulla base del punteggio composito alla visita della Settimana 52. La risposta clinica (composita) ¿ definita come diminuzione rispetto al baseline dello studio di induzione (SHP647-301 o SHP647-302) del punteggio composito dei sintomi riferiti dal soggetto mediante la compilazione giornaliera del diario elettronico e la 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 =1.; ¿ Percentuale di soggetti che presentano guarigione della mucosa sulla base della valutazione endoscopica e istologica alla visita della Settimana 52. La guarigione della mucosa ¿ definita da un sottopunteggio endoscopico letto centralmente di 0 o 1 (modificato, esclude la friabilit¿) e un punteggio Geboes letto centralmente =2.; ¿ Percentuale di soggetti che raggiungono remissione clinica libera da glucocorticoidi alla Settimana 52, tra i soggetti che utilizzano glucocorticoidi al baseline dello studio SHP647-303. La remissione clinica libera da glucocorticoidi ¿ definita come remissione clinica, oltre alla non richiesta di trattamento con glucocorticoidi per almeno 4 settimane prima della visita della Settimana 52. La remissione clinica ¿ definita come 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 52.; ¿ Percentuale di soggetti che raggiungono remissione libera da glucocorticoidi alla Settimana 52, tra i soggetti che utilizzano glucocorticoidi al baseline dello studio SHP647-303. La remissione libera da glucocorticoidi ¿ definita come remissione, oltre alla non richiesta di trattamento con glucocorticoidi per almeno 4 settimane prima della visita della Settimana 52. La remissione ¿ definita come un punteggio composito dei sintomi riferiti dal soggetto mediante la compilazione giornaliera del diario elettronico e l¿endoscopia, con il sottopunteggio di frequenza delle feci di 0 o 1 con variazione di almeno 1 punto rispetto al baseline dello studio di induzione (SHP647-301 o SHP647-302), il sottopunteggio per il sanguinamento rettale di 0 o 1 e il sottopunteggio endoscopico di 0 o 1 (modificato, esclude la friabilit¿).
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 52 visit; week 52 visit; week 52 visit; week 52 visit; week 52 visit; week 52 visit; week 52 visit
    visita alla settimana 52; visita alla settimana 52; visita alla settimana 52; visita alla settimana 52; visita alla settimana 52; visita alla settimana 52; visita alla 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
    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 25 mg o 75 mg
    25 mg or 75 mg 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 EEA337
    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
    France
    Germany
    Greece
    Hungary
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Lebanon
    Lithuania
    Mexico
    Netherlands
    New Zealand
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Switzerland
    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 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 della sperimentazione ¿ definita come la data in cui l'ultimo soggetto, in tutti i centri, completa la valutazione finale definita dal protocollo. Si noti che ci¿ include la visita o il contatto di follow-up, a seconda di quale evento si verifica pi¿ tardi.
    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 months5
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days18
    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: 77
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 679
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 305
    F.4.2.2In the whole clinical trial 772
    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 52 week treatment period, the subject will either
    enter the LTS study (SHP647 304) or the 16 week safety follow up
    period.
    Alla fine del periodo di trattamento di 52 settimane, il soggetto entrer¿ nello studio LTS (SHP647 304) o nel periodo del follow-up di sicurezza di 16 settimane.
    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
    P.Date of the global end of the trial2021-07-01
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