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    Summary
    EudraCT Number:2019-001087-30
    Sponsor's Protocol Code Number:CT-P13_3.8
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-17
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-001087-30
    A.3Full title of the trial
    A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease
    Studio randomizzato, in doppio cieco, controllato con placebo, di fase III per valutare l’efficacia e la sicurezza dell’iniezione sottocutanea di CT-P13 (CT-P13 SC) come terapia di mantenimento in pazienti con malattia di Crohn attiva di grado da moderato a severo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease
    Valutare l’efficacia e la sicurezza dell’iniezione sottocutanea di CT-P13 (CT-P13 SC) come terapia di mantenimento in pazienti con malattia di Crohn
    A.3.2Name or abbreviated title of the trial where available
    /
    /
    A.4.1Sponsor's protocol code numberCT-P13_3.8
    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 SponsorCELLTRION INC.
    B.1.3.4CountryKorea, Republic of
    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 supportCelltrion, Inc
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelltrion, Inc
    B.5.2Functional name of contact pointSung Hyun Kim
    B.5.3 Address:
    B.5.3.1Street Address23, Academy-ro
    B.5.3.2Town/ cityYeonsu-gu, Incheon
    B.5.3.3Post code22014
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number82328505778
    B.5.5Fax number82328371203
    B.5.6E-mailsunghyun.kim@celltrion.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Inflectra
    D.2.1.1.2Name of the Marketing Authorisation holderCelltrion Healthcare Hungary Kft EU/1/13/853/006 (007, 010, 008, 011, 015, 016, 009)
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 [CT-P13]
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.2Current sponsor code/
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.2.1.1.1Trade name Remisma
    D.2.1.1.2Name of the Marketing Authorisation holderCelltrion Healthcare Hungary Kft.
    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 name00000
    D.3.2Product code [CT-P13]
    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 INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.2Current sponsor codeCT-P13
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.2Current sponsor codeCT-P13
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    Moderately to Severely Active Crohn's Disease
    Malattia di Crohn attiva di grado da moderato a severo
    E.1.1.1Medical condition in easily understood language
    Crohn's Disease
    Malattia di Crohn
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superiority of CT-P13 SC over Placebo SC based on clinical remission and endoscopic response at Week 54.
    Dimostrare la superiorità di CT-P13 SC rispetto al Placebo SC in base a remissione clinica e risposta endoscopica alla Settimana 54
    E.2.2Secondary objectives of the trial
    To evaluate additional efficacy, PK, pharmacodynamics (PD) and overall safety including immunogenicity
    Valutare ulteriormente l'efficacia, la farmacocinetica (PK), la farmacodinamica (PD) e la sicurezza generale, compresa l'immunogenicità
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is male or female aged 18 to 75 years, inclusive.
    2. Patient who has moderately to severely active CD with a score on the CDAI of 220 to 450 points at Screening.
    3. Patient with average (of 7 days) daily stool frequency >=4 points (of Type 6 or Type 7 on the BSFS and/or an average (of 7 days) worst daily abdominal pain of >=2 points (using 4 point scale) at Screening.
    4. Patient who has a SES CD of >=6 points for ileal-colonic CD or >=4 points including ulcer score from at least 1 segment for ileal CD or colonic CD at Screening.
    5. Patient who has CD, confirmed at any time in the past by radiography, histology, or endoscopy, of at least 3 months' disease duration prior to the first administration of the study drug (Day 0).
    6. Patient who has been treated for active CD but has not responded despite a full and adequate course of therapy with corticosteroids and/or immunosuppressants; or who is intolerant to or has medical contraindications for such therapies.
    7. Patient who is receiving a stable dose of the following CD treatments or currently not receiving CD treatment during the specified time frame:
    • Azathioprine (AZA), 6-mercaptopurine (6-MP) or Methotrexate (MTX) for at least 8 weeks prior to the first administration of the study drug (Day 0)
    • Oral corticosteroids at the equivalent dose of 20 mg/day or less of prednisone for at least 2 weeks prior to the first administration of the study drug (Day 0)
    • Oral budesonide at a dose of 6 mg/day or less for at least 4 weeks prior to the first administration of the study drug (Day 0)
    • 5-Aminosalicylates (5-ASA) or antibiotics (i.e., ciprofloxacin, metronidazole) for at least 4 weeks prior to the first administration of the study drug (Day 0)
    8. Patient who has adequate renal and hepatic function at Screening as defined by the following clinical chemistry results:
    • Serum creatinine <1.5×upper limit of normal (ULN) or an estimated
    creatinine clearance level >50 mL/min (by Cockcroft-Gault formula)
    • Serum alanine aminotransferase <2.5×ULN
    • Serum aspartate aminotransferase <2.5×ULN
    • Serum total bilirubin <2×ULN
    9. Patient who has the following clinical hematology results at Screening:
    • Hemoglobin >=8.5 g/dL (SI [Système International d'Unités] units: >=85
    g/L or 5.28 mmol/L)
    • White blood cell count >=3.5×103 cells/µL (SI units: >=3.5×109 cells/L)
    • Neutrophil count >=1.5×10*3 cells/µL (SI units: >=1.5×10*9 cells/L)
    • Platelet count >=100×10*3 cells/µL (SI units: >=100×10*9 cells/L)
    10. Patient (or legal guardian, if applicable) who is informed of the full nature and purpose of the study, including possible risks and side effects, has the ability to cooperate with the investigator and is given ample time and opportunity to read or understand verbal and/or written instructions, and has signed and dated the written informed consent form (ICF) prior to participation in the study.
    11. For both male and female patients, the patient and his or her partner of childbearing potential who agree to use one of the following medically acceptable methods of contraception during the course of the study and for 6 months following discontinuation of study drug (excluding women who are not of childbearing potential and men who have been sterilized):
    • Barrier contraceptives (male condom, female condom, or diaphragm with a spermicidal gel)
    • Hormonal contraceptives (implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings)
    • Intrauterine device
    1.Paziente di sesso maschile o femminile di età compresa tra 18 e 75 anni inclusi
    2.Paziente affetto/a da CD attiva di grado da moderato a severo con un punteggio CDAI da 220 a 450 punti allo Screening
    3.Paziente con frequenza media (su 7 giorni) giornaliera delle feci >= 4 punti (di Tipo 6 o Tipo 7 sulla BSFS) e/o peggior dolore addominale giornaliero medio (su 7 giorni) >= 2 punti (utilizzando una scala a 4 punti) allo Screening
    4.Paziente con SES-CD >= 6 punti per CD di colon e ileo o >= 4 punti incluso il punteggio per l'ulcera da almeno 1 segmento per CD dell'ileo o per CD del colon allo Screening.
    5.Paziente con CD confermata in qualsiasi momento in passato tramite esame radiografico, istologico o endoscopico, e durata della malattia di almeno 3 mesi prima della prima somministrazione del farmaco in studio (Giorno 0).
    6.Paziente trattato/a per CD attiva ma che non ha risposto nonostante un ciclo completo e adeguato di terapia con corticosteroidi e/o immunosoppressori; o che è intollerante a queste terapie o presenta controindicazioni mediche per tali terapie.
    7.Paziente che riceve una dose stabile dei seguenti trattamenti per CD o che attualmente non riceve un trattamento per CD durante il periodo di tempo specificato:
    •Azatioprina (AZA) o 6-mercaptopurina (6-MP) o Metotrexato (MTX) per almeno 8 settimane prima della prima somministrazione del farmaco in studio (Giorno 0)
    •Corticosteroidi per via orale alla dose equivalente di 20 mg/die o meno di prednisone per almeno 2 settimane prima della prima somministrazione del farmaco in studio (Giorno 0)
    •Budesonide per via orale alla dose di 9 mg/die (se il dosaggio specifico per paese è stato approvato per il trattamento per CD) o di 6 mg/die o meno per almeno 4 settimane prima della prima somministrazione del farmaco in studio (Giorno 0)
    •5-aminosalicilati (5-ASA) o antibiotici (ovvero ciprofloxacina, metronidazolo) per almeno 4 settimane prima della prima somministrazione del farmaco in studio (Giorno 0)
    8.Paziente che presenta funzionalità renale ed epatica adeguate allo screening come definito dai seguenti risultati degli esami di chimica clinica:
    •Creatinina sierica < 1,5 × limite superiore della norma (ULN) o un livello stimato di clearance della creatinina > 50 ml/min (in base alla formula di Cockcroft-Gault)
    •Alanina aminotransferasi sierica < 2,5 × ULN
    •Aspartato aminotransferasi sierica < 2,5 × ULN
    •Bilirubina sierica totale < 2 × ULN
    9.Allo screening, il/la paziente presenta i seguenti risultati degli esami clinici ematologici:
    •Emoglobina >= 8,5 g/dl (Unità SI [Sistema Internazionale di Unità di misura]: >= 85 g/l o 5,28 mmol/l)
    •Conta dei globuli bianchi >= 3,5 × 10*3 cellule/µl (Unità SI: >= 3,5 × 10*9 cellule/l)
    •Conta dei neutrofili >= 1,5 × 10*3 cellule/µl (Unità SI: >= 1,5 × 10*9 cellule/l)
    •Conta delle piastrine >= 100 × 10*3 cellule/µl (Unità SI: >= 100 × 10*9 cellule/l)
    10.Paziente (o tutore legale, se applicabile) pienamente informato sulla natura e sullo scopo dello studio, compresi i possibili rischi ed effetti collaterali, che ha la capacità di collaborare con lo sperimentatore e al quale vengono concessi tutto il tempo e le opportunità necessari per leggere o comprendere le istruzioni in forma orale o scritta e che ha sottoscritto e datato il modulo di consenso informato (ICF) scritto prima della partecipazione allo studio.
    11.Per i pazienti di entrambi i sessi: paziente e rispettivo/a partner in età fertile che accettano di utilizzare uno dei seguenti metodi contraccettivi accettabili dal punto di vista medico per tutta la durata dello studio e nei 6 mesi successivi alla sospensione del farmaco in studio (ad esclusione delle donne non in età fertile e degli uomini resi sterili):
    •contraccettivi di barriera (preservativo maschile, preservativo femminile o diaframma con un gel spermicida)
    •contraccettivi ormonali (impianti, iniettabili, contraccettivi orali in combinazione, cerotti transdermici o anelli contraccettivi)
    •Dispositivo intrauterino
    E.4Principal exclusion criteria
    1. Patient who has previously received 2 or more biologic agents, 2 or more Janus kinase (JAK) inhibitors, or 2 or more of both biologic agents and JAK inhibitors.
    2. Patient who has previously demonstrated inadequate response or intolerance to TNFa inhibitors for the treatment of CD.
    3. Patient who has previously received infliximab for treatment of CD or other disease.
    4. Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins, or has a hypersensitivity to immunoglobulin products.
    5. Patient who has received or has a plan to receive any of following prohibited medications or treatments:
    • Parenteral corticosteroids for the treatment of CD within 2 weeks prior to the first administration of the study drug (Day 0)
    • Janus kinase (JAK) inhibitors therapy including but not limited to tofacitinib and baricitinib within 4 weeks prior to the first administration of the study drug (Day 0)
    • Alkylating agents within 12 months prior to the first administration of the study drug (Day 0)
    • Cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks prior to the first administration of the study drug (Day 0)
    • Live or live-attenuated vaccine within 4 weeks prior to the first administration of the study drug (Day 0)
    • Abdominal surgery for, including but not limited to, active gastrointestinal bleeding, peritonitis, intestinal obstruction, gastrointestinal resection or intra abdominal or pancreatic abscess requiring surgical drainage within 6 months prior to the first administration of the study drug (Day 0)
    • Nonautologous stem cell therapy (e.g., Prochymal) within 12 months prior to the first administration of the study drug (Day 0)
    • Apheresis (e.g., Adacolumn apheresis) for the treatment of CD within 3 weeks prior to the first administration of the study drug (Day 0)
    • Use of total parenteral nutrition within a month prior to the first administration of the study drug (Day 0)
    • Use of exclusive enteral nutrition for more than 3 consecutive days within a month or any single day of exclusive enteral nutrition within 2 weeks prior to the first administration of the study drug (Day 0)
    6. Patient who has a current or history of any of the following infections:
    • Known infection with hepatitis B or hepatitis C (active or carrier state), or infection with human immunodeficiency virus (HIV). However, a patient who is without cirrhosis of liver and recovered from a past hepatitis B or hepatitis C infection can be enrolled. In case of hepatitis C infection, patient who has achieved a sustained virologic response (SVR) for at least 12 weeks after completing the treatment for hepatitis C infection can be enrolled.
    • Acute infection requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug (Day 0)
    • Other serious infection, in the investigator's opinion, within 6 months prior to the first administration of the study drug (Day 0)
    • Other chronic or recurrent infection, in the investigator's opinion, within 6 weeks prior to the first administration of the study drug (Day 0)
    • Past or current granulomatous infections or opportunistic infections (e.g., herpes zoster, cytomegalovirus, Pneumocystis carinii, aspergillosis, or mycobacteria other than TB) or invasive fungal infection (e.g., histoplasmosis)
    7. Patient who has a medical condition including 1 or more of the following:
    • Diagnosed with UC or indeterminate colitis
    1. Paziente che ha precedentemente ricevuto 2 o più agenti biologici, 2 o più inibitori della janus chinasi (JAK), oppure 2 o più di entrambi agenti biologici e inibitori della JAK
    2. Paziente che ha precedentemente dimostrato una risposta inadeguata o un'intolleranza agli inibitori del TNFa per il trattamento della CD.
    3. Paziente che ha precedentemente ricevuto infliximab per il trattamento della CD o altre malattie.
    4. Paziente che presenta allergie a uno qualsiasi degli eccipienti di infliximab, a qualsiasi altra proteina murina e/o umana, o con un'ipersensibilità a prodotti contenenti immunoglobulina.
    5. Paziente che ha ricevuto o ha in programma di ricevere uno qualsiasi dei seguenti farmaci o trattamenti vietati:
    • Corticosteroidi per via parenterale per il trattamento della CD entro 2 settimane prima della prima somministrazione del farmaco in studio (Giorno 0)
    • Terapia con inibitori della janus chinasi (JAK) compresi, a titolo esemplificativo, tofacitinib e baricitinib nelle 4 settimane precedenti la prima somministrazione del farmaco in studio (Giorno 0)
    • Agenti alchilanti nei 12 mesi precedenti la prima somministrazione del farmaco in studio (Giorno 0)
    • Ciclosporina, tacrolimus, sirolimus o micofenolato mofetile entro le 8 settimane precedenti la prima somministrazione del farmaco in studio (Giorno 0)
    • Vaccinazione con vaccini vivi o vivi-attenuati entro le 4 settimane precedenti la prima somministrazione di farmaco in studio (Giorno 0)
    • Intervento chirurgico addominale, compresi, a titolo esemplificativo, intervento per emorragia gastrointestinale attiva, peritonite, ostruzione intestinale, resezione gastrointestinale o ascesso intra-addominale o pancreatico che richieda drenaggio chirurgico nei 6 mesi precedenti la prima somministrazione del farmaco in studio (Giorno 0)
    • Terapia con cellule staminali non autologhe (come, ad esempio, Prochymal) nei 12 mesi precedenti la prima somministrazione del farmaco in studio (Giorno 0)
    • Aferesi (ad esempio aferesi con Adacolumn) per il trattamento della CD nei 3 mesi precedenti la prima somministrazione del farmaco in studio (Giorno 0)
    • Uso di nutrizione parenterale totale entro un mese prima della prima somministrazione del farmaco in studio (Giorno 0)
    • Uso esclusivamente di nutrizione enterale per più di 3 giorni consecutivi in un mese o un singolo giorno di nutrizione esclusivamente enterale nelle 2 settimane precedenti la prima somministrazione del farmaco in studio (Giorno 0)
    6. Paziente che presenta un’anamnesi attuale di una delle seguenti infezioni:
    • Infezione nota da epatite B o epatite C (stato attivo o di portatori), o infezione da virus dell'immunodeficienza umana (HIV). Tuttavia, un/una paziente che non presenta cirrosi epatica ed è guarito da un'infezione passata di epatite B o epatite C può essere arruolato/a. In caso di infezione da epatite C, un/una paziente che ha raggiunto una risposta virologica prolungata (SVR) da almeno 12 settimane dopo aver completato il trattamento per l’infezione da epatite C può essere arruolato/a.
    • Infezione acuta che richiede l'uso di antibiotici per via orale entro 2 settimane o iniezione parenterale di antibiotici entro le 4 settimane precedenti la prima somministrazione del farmaco in studio (Giorno 0)
    • Altre infezioni serie, secondo il giudizio dello sperimentatore, nei 6 mesi precedenti la prima somministrazione del farmaco in studio (Giorno 0)
    • Altre infezioni croniche o ricorrenti, secondo il giudizio dello sperimentatore, nelle 6 settimane precedenti la prima somministrazione del farmaco in studio (Giorno 0)
    • Infezioni granulomatose passate o in corso o infezioni opportunistiche (ad es. herpes zoster, citomegalovirus, Pneumocystis carinii, aspergillosi o micobatteri diversi dalla TB) o infezioni fungine invasive (ad es. istoplasmosi)
    7. Paziente che presenta una condizione medica comprendente uno o più dei seguenti fattori:
    • Diagnosi di UC o colite indeterminata
    E.5 End points
    E.5.1Primary end point(s)
    • Clinical remission at Week 54, defined as an absolute CDAI score of <150 points
    • Endoscopic response at Week 54, defined as a 50% decrease in SES-CD score from the baseline value
    • Remissione clinica alla Settimana 54, definita come un punteggio CDAI assoluto < 150
    • Risposta endoscopica alla Settimana 54, definita come una diminuzione del 50% del punteggio SES-CD rispetto al valore basale
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endopoint evaluation will be conducted at Week 54.
    La valutazione degli endpointprimari sarà condotta alla Settimana 54.
    E.5.2Secondary end point(s)
    Key Secondary endpoints
    • CDAI-100 response at Week 54, defined as a decrease in CDAI score of 100 points or more from the baseline value
    • Clinical remission at Week 54, defined as an average worst daily abdominal pain score of = 1 (using 4-point scale), and an average loose/watery stool frequency score of = 3 (of Type 6 or Type 7 on BSFS) with no worsening in either score compared to the baseline value
    • Corticosteroid-free remission at Week 54, defined as being in clinical remission (by an absolute CDAI score of <150) in addition to not receiving oral corticosteroid for at least 8 weeks prior to Week 54, among the patients who used oral corticosteroids at baseline
    • Endoscopic remission at Week 54, defined as an absolute SES-CD score of = 4 and at least 2-point reduction from the baseline value with no sub-score of >1
    Other Secondary endpoints:
    • Clinical remission, defined as an absolute CDAI score of <150 points
    • Maintenance of clinical remission at Week 54, defined as being in clinical remission by CDAI score of <150 points, among the patients in clinical remission at Week 10
    • Sustained clinical remission at both Week 22 and Week 54, defined as an average worst daily abdominal pain score of =1 (using 4-point scale), and an average loose/watery stool frequency score of =3 (of Type 6 or Type 7 on BSFS) at both Week 22 and Week 54 with no worsening in either score compared to the baseline value
    • CDAI-70 response, defined as a decrease in CDAI score of 70 points or more from the baseline value
    • CDAI-100 response, defined as a decrease in CDAI score of 100 points or more from the baseline value
    • Maintenance of clinical response at Week 54, defined as being in CDAI- 100 response at Week 54, among the patients in CDAI-100 response at Week 10
    • Sustained clinical response at both Week 22 and Week 54, defined as a reduction from the baseline value in average worst daily abdominal pain score (using 4-point scale), and/or in average daily loose/watery stool frequency (of Type 6 or Type 7 on BSFS) at both Week 22 and Week 54
    • Endoscopic remission, defined as an absolute SES-CD score of =4 and at least 2-point reduction from the baseline value with no sub-score of >1
    • Endoscopic response, defined as a 50% decrease in SES-CD score from the baseline value
    • Patient global scale, defined as a question that asks a patient's position on achieving remission from his or her CD symptoms (Yes or No)
    • Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
    Pharmacokinetic Assessments:
    For all patients, Ctrough will be assessed up to Week 100 and Cmax will be assessed at Week 6. Blood samples for PK analysis will be collected at pre-dose of Weeks 0, 2, 6, 10, 14, 22, 30, 38, 46, 54, 62, 70, 78, 86, 94, 102 and within 15 minutes after the end of the study drug infusion of Week 6. On the day of initiation dose adjustment, blood sample for PK analyses will be collected at pre-dose.
    For patients who agreed to collect further blood samples, additional blood samples for further Population PK analysis will be collected at following time points:
    • Any time between 48 hours and 72 hours after study drug administration of Week 22
    Endpoint secondari principali:
    • Risposta CDAI-100 alla Settimana 54, definita come una diminuzione del punteggio CDAI di 100 punti o più rispetto al valore basale
    • Remissione clinica alla Settimana 54, definita come punteggio medio del dolore addominale giornaliero peggiore = 1 (utilizzando una scala a 4 punti), e un punteggio medio di frequenza delle feci molli/liquide = 3 (di Tipo 6 o Tipo 7 sulla BSFS) senza alcun peggioramento di nessuno dei due punteggi rispetto al valore basale
    • Remissione senza trattamento con corticosteroidi alla Settimana 54, definita come remissione clinica (tramite un punteggio assoluto CDAI < 150) insieme all’assenza della somministrazione di corticosteroidi per almeno 8 settimane prima della Settimana 54, tra i pazienti che assumevano corticosteroidi orali al baseline
    • Remissione endoscopica alla Settimana 54, definita come un punteggio assoluto SES-CD = 4 e una riduzione di almeno 2 punti rispetto al valore basale senza alcun sotto-punteggio > 1
    Altri endpoint secondari:
    • Remissione clinica, definita come un punteggio CDAI assoluto < 150 punti
    • Mantenimento della remissione clinica alla Settimana 54, definita come remissione clinica tramite punteggio CDAI < 150 punti, tra i pazienti in remissione clinica alla Settimana 10
    • Remissione clinica prolungata sia alla Settimana 22 che alla Settimana 54, definita come un punteggio medio giornaliero del dolore addominale peggiore = 1 (utilizzando una scala a 4 punti) e un punteggio medio della frequenza di feci molli/liquide = 3 (di Tipo 6 o Tipo 7 sulla BSFS) sia alla Settimana 22 che alla Settimana 54, senza alcun peggioramento di nessuno dei due punteggi rispetto al valore basale
    • Risposta CDAI-70, definita come una diminuzione del punteggio CDAI di 70 punti o più rispetto al valore basale
    • Risposta CDAI-100, definita come una diminuzione del punteggio CDAI di 100 punti o più rispetto al valore basale
    • Mantenimento della risposta clinica alla Settimana 54, definita come presenza della risposta CDAI-100 alla Settimana 54, tra i pazienti con risposta CDAI-100 alla Settimana 10
    • Risposta clinica prolungata sia alla Settimana 22 che alla Settimana 54, definita come una riduzione rispetto al valore basale del punteggio medio giornaliero del dolore addominale peggiore (utilizzando una scala a 4 punti) e/o della frequenza media giornaliera di feci molli/liquide (di Tipo 6 o Tipo 7 sulla BSFS) sia alla Settimana 22 che alla Settimana 54
    • Remissione endoscopica, definita come un punteggio assoluto SES-CD = 4 e una riduzione di almeno 2 punti rispetto al valore basale senza alcun sotto-punteggio > 1
    • Risposta endoscopica, definita come una diminuzione del 50% del punteggio SES-CD rispetto al valore basale
    • Scala globale del paziente, definita come una domanda sulla posizione del paziente in merito al raggiungimento della remissione dai sintomi di CD (Sì o No)
    • Questionario SIBDQ (Short Inflammatory Bowel Disease Questionnaire, Questionario breve sulla malattia infiammatoria intestinale)
    Valutazioni farmacocinetiche:
    Per tutti i pazienti la Cmin sarà valutata fino alla Settimana 100 e la Cmax sarà valutata alla Settimana 6:
    Campioni di sangue per le analisi di farmacocinetica (PK) saranno raccolti prima della somministrazione della dose (prima dell’inizio della somministrazione del farmaco in studio) delle Settimane 0, 2, 6, 10, 14, 22, 30, 38, 46, 54, 62, 70, 78, 86, 94, 102 ed entro 15 minuti dopo la fine dell’infusione di farmaco in studio della Settimana 6. Il giorno in cui inizia l’adeguamento della dose, saranno raccolti campioni di sangue per analisi di PK, prima della somministrazione.
    Per pazienti che hanno accettato la raccolta di campioni di sangue aggiuntivi per ulteriori analisi di Farmacocinetica della popolazione, i campioni verranno raccolti con la seguente tempistica.
    • In qualsiasi momento tra 48 ore e 72 ore dopo la somministrazione del farmaco in studio della Settimana 22
    E.5.2.1Timepoint(s) of evaluation of this end point
    Key secondary endopoints evaluations will be conducted at Week 54 and other secondary endopoints evaluations will be conducted at time points described in protocol. PK, PD and safety assessments will be perfored at the time points specificed in the schedule of events (Table 10-1 and 10- 2).
    Le valutazioni degli endpoint secondari principali saranno condotte alla Settimana 54 e altre valutazioni degli endopoint secondari saranno condotte nei punti temporali descritti nel protocollo. Valutazioni di PK, PD e di sicurezza saranno condotte nei punti temporali specificati nel programma degli eventi (Tabella 10-1 e 10-2).
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA106
    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
    Belarus
    Brazil
    Bulgaria
    Chile
    Croatia
    Czechia
    France
    Germany
    Greece
    Hungary
    India
    Israel
    Italy
    Japan
    Latvia
    Mexico
    Moldova, Republic of
    Peru
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Turkey
    Ukraine
    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
    LVLS
    LVLS
    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 months11
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 552
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 600
    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)
    Patients will transition to local standard of care treatment if required in the opinion of the investigator.
    I pazienti passeranno al trattamento standard di cura locale se richiesto a giudizio 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 Decision2019-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-04
    P. End of Trial
    P.End of Trial StatusOngoing
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