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    Summary
    EudraCT Number:2019-001087-30
    Sponsor's Protocol Code Number:CT-P13_3.8
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-09-10
    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 ConcernedSpain - AEMPS
    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
    Estudio de fase III, aleatorizado, doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de CT-P13 en inyección subcutánea (CT-P13 SC) como tratamiento de mantenimiento en pacientes con enfermedad activa de Crohn de moderada a grave
    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
    Evaluando eficacia y seguridad de CT-P13 subcutáneo (CT-P13 SC) como terapia de mantenimiento en pacientes con enfermedad de Crohn
    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 organisationPPD
    B.5.2Functional name of contact pointGlobal Project Management
    B.5.3 Address:
    B.5.3.1Street AddressBlock 15, Woodlands Office park, Woodmead
    B.5.3.2Town/ cityJohannesburg
    B.5.3.3Post code1930
    B.5.3.4CountrySouth Africa
    B.5.4Telephone number900 834 223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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.3.2Product code CT-P13
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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.3.11 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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 Inflectra
    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.3.2Product code CT-P13
    D.3.4Pharmaceutical form Powder for concentrate 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.3.9.4EV 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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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: 3
    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.3.2Product code CT-P13
    D.3.4Pharmaceutical form Solution for injection in pre-filled injector
    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.3.11 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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    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
    Enfermedad activa de Crohn de moderada a grave
    E.1.1.1Medical condition in easily understood language
    Crohn’s Disease
    Enfermedad de 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.
    Demostrar la superioridad de CT-P13 SC sobre el placebo SC basándose en la remisión clínica y la respuesta endoscópica en la semana 54.
    E.2.2Secondary objectives of the trial
    To evaluate additional efficacy, PK, pharmacodynamics (PD), usability, and overall safety including immunogenicity
    Evaluar la eficacia adicional, la farmacocinética (FC), la farmacodinámica (FD), la manejabilidad y la seguridad global, incluida la inmunogenicidad.
    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 ≥1.5×103 cells/µL (SI units: ≥1.5×109 cells/L)
    • Platelet count ≥100×103 cells/µL (SI units: ≥100×109 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
    Male and female patients and their partners who have been surgically sterilized for less than 6 months prior to the date of informed consent must agree to use any of the medically acceptable methods of contraception. Menopausal females must have experienced their last period more than 12 months prior to the date of informed consent to be classified as not of childbearing potential.
    1.Ser varón o mujer de 18 a 75 años de edad, ambos inclusive.
    2.Presentar EC activa de moderada a grave con una puntuación CDAI de 220 a 450 puntos en el período de selección.
    3.Tener una frecuencia diaria media (a lo largo de 7 días) de deposiciones ≥ 4 (de tipo 6 o 7 según la BSFS) o una puntuación diaria media (a lo largo de 7 días) del peor dolor abdominal ≥ 2 (en la escala de 4 puntos) en el período de selección.
    4.Tener una puntuación de la SES-CD ≥ 6 para la EC ileal-colónica or ≥ 4 puntos incluida la puntuación de úlcera en al menos un segmento para la EC ileal o la EC colónica en el período de selección.
    5.Presentar EC, confirmada en cualquier momento del pasado mediante radiografía, histología o endoscopia, desde al menos 3 meses antes de la primera administración del fármaco del estudio (día 0).
    6.Haber recibido tratamiento para la EC pero sin respuesta a un ciclo de tratamiento completo y adecuado con un corticosteroide o un inmunodepresor, o bien presentar intolerancia a dicho tratamiento o contraindicaciones médicas para su administración.
    7. Estar recibiendo los siguientes tratamientos para la EC en dosis estables o no estar recibiendo actualmente tratamiento para la EC ni haberlo hecho durante el período especificado:
    -Azatioprina (AZA), 6-mercaptopurina (6-MP) o metotrexato (MTX) desde al menos 8 semanas antes de la primera administración del fármaco del estudio (día 0).
    -Corticosteroides orales en dosis equivalente a 20 mg/día o menos de prednisona desde al menos 2semanas antes de la primera administración del fármaco del estudio (día 0).
    -Budesonida oral en dosis equivalente a 6 mg/día o menos durante al menos 4 semanas antes de la primera administración del fármaco del estudio (día 0).
    -5-aminosalicilatos (5-ASA) o antibióticos (es decir, ciprofloxacino, metronidazol) durante al menos 4 semanas antes de la primera administración del fármaco del estudio (día 0).
    8.Tener una función renal y hepática adecuada en el período de selección, definida por los siguientes resultados de bioquímica clínica:
    -Creatinina sérica < 1,5 veces el límite superior de la normalidad (LSN) o aclaramiento de creatinina calculado > 50 ml/min (según la fórmula de Cockroft-Gault).
    -Alanina-aminotransferasa sérica < 2,5 veces el LSN.
    -Aspartato-aminotransferasa sérica < 2,5 veces el LSN.
    -Bilirrubina total en suero < 2 veces el LSN.
    9. Presentar los siguientes resultados de hematología clínica en la fase selección:
    -Hemoglobina ≥ 8,5 g/dl (unidades SI [Sistema Internacional]: ≥ 85 g/l o 5,28 mmol/l).
    -Recuento de leucocitos ≥ 3,5 × 103células/µl (unidades SI: ≥ 3,5 × 109células/l).
    -Recuento de neutrófilos ≥ 1,5 × 103 células/µl (unidades SI: ≥ 1,5 × 109células/l).
    -Recuento de plaquetas ≥ 100 × 103células/µl (unidades SI: ≥ 100 × 109células/l).
    10.El paciente (o su tutor legal cuando proceda) está enteramente informado de la naturaleza y el objetivdel estudio, incluidos los posibles riesgos y efectos secundarios, tiene la capacidad de colaborar con einvestigador, se le ha dado el tiempo suficiente y la oportunidad de leer y entender instruccioneverbales o por escrito y ha firmado y fechado el documento de consentimiento informado (DCI) antede participar en el estudio.
    11.Tanto si son varones como mujeres, los pacientes y sus parejas en edad fértil se comprometen a utilizauno de los siguientes métodos anticonceptivos médicamente aceptables durante el estudio y durante lo6 meses siguientes a la suspensión del tratamiento con fármaco del estudio (exceptuando las mujeres sicapacidad de procrear y los varones esterilizados):
    -Anticonceptivos de barrera (preservativo masculino, preservativo femenino o diafragma con geespermicida).
    -Anticonceptivos hormonales (implantes, inyectables, anticonceptivos orales combinados, parchetransdérmicos o anillos anticonceptivos).
    -Dispositivo intrauterino.
    Los pacientes, tanto varones como mujeres, y sus parejas que hayan sido esterilizados por métodosquirúrgicos menos de 6 meses antes de la fecha del consentimiento informado deberán comprometerse autilizar cualquier método anticonceptivo médicamente aceptable. Se considera que no están en edad fértil las mujeres posmenopáusicas que hayan tenido su última menstruación más de 12 meses antes dela fecha del consentimiento informado.
    E.4Principal exclusion criteria
    1. Patient who has previously received either a TNFα inhibitor or biological agent within 5 half-lives prior to the first administration of the study drug (Day 0).
    2. Patient who has previously demonstrated inadequate response or intolerance to TNFα 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
    • Extensive colonic resection (subtotal and total colectomy) prior to the first administration of the study drug (Day 0)
    • History of more than 3 small-bowel resection procedures prior to the first administration of the study drug (Day 0)
    • Diagnosed with short bowel syndrome
    • Evidence of fixed symptomatic stenosis or obstruction of the large or small intestine
    • Currently require or are anticipated to require surgical intervention for CD during the study
    • Active entero-vesical, entero-retroperitoneal, entero-cutaneous, or entero-vaginal fistulae within 6 months prior to the first administration of the study drug (Day 0). Entero-enteral fistulae without clinically significant symptoms in the investigator’s opinion and anal fistulae without draining problems are allowed
    • Stoma (e.g., ileostomy or colostomy) within 6 months prior to the first administration of the study drug (Day 0)
    • Evidence of infection from enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin within 6 months prior to the first administration of the study drug (Day 0)
    • Body mass index ≥35 kg/m2
    • Uncontrolled diabetes mellitus, even after insulin treatment
    • Uncontrolled hypertension (as defined by systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg)
    1.Haber recibido un inhibidor del TNFα o un fármaco biológico en las 5 semividas previas a 1ªadministración del fármaco del estudio (día 0)
    2.Haber presentado una respuesta insuficiente o intolerancia al tratamiento previo con inhibidores del TNFα para la EC
    3.Haber recibido con anterioridad infliximab para el tratamiento de la EC o de otra enfermedad
    4.Ser alérgico a cualquiera de los excipientes de infliximab o a otras proteínas murinas o humanas, o haber sufrido reacciones de hipersensibilidad a productos que contengan inmunoglobulinas
    5.Haber recibido o tener previsto recibir alguno de los siguientes medicamentos o tratamientos prohibidos:
    -Corticosteroides parenterales para el tratamiento de la EC en las 2 semanas previas a 1ªadministración del fármaco del estudio (día 0)
    -Inhibidores de la cinasa Janus (JAK) como tofacitinib y baricitinib, entre otros, en las 4 semanas previas a 1ªadministración del fármaco del estudio (día 0)
    -Agentes alquilantes en los 12 meses previos a 1ªadministración del fármaco del estudio(día 0)
    -Ciclosporina, tacrolimús, sirolimús o micofenolato de mofetilo en las 8 semanas previas a 1ªadministración del fármaco del estudio (día 0)
    -Vacuna de organismos vivos o atenuados en las 4semanas previas a 1ªadministración del fármaco del estudio(día 0)
    -Cirugía abdominal por, entre otros motivos,hemorragia digestiva activa,peritonitis,obstrucción intestinal,resección gastrointestinal o absceso intraabdominal o pancreático que precisa drenaje quirúrgico en los 6 meses previos a 1ªadministración del fármaco del estudio(día 0)
    -Terapia con células progenitoras no autólogas (p. ej., Proquimmal) en los 12 meses previos a 1ªadministración del fármaco del estudio (día 0)
    -Aféresis (por ejemplo, aféresis con Adacolumn) para el tratamiento de la EC en las 3 semanas previas a 1ªadministración del fármaco del estudio (día 0)
    -Alimentación parenteral total en el mes previo a 1ªadministración del fármaco del estudio(día 0)
    -Alimentación enteral exclusiva durante más de 3 días consecutivos en el último mes o un único día de alimentación enteral exclusiva en las 2 semanas previas a 1ªadministración del fármaco del estudio (día 0)
    6.Antecedentes o diagnóstico actual de las siguientes infecciones:
    -Infección confirmada por el virus de la hepatitis B o el virus de la hepatitis C (activa o en estado de portador) o por el virus de la inmunodeficiencia humana (VIH). Los pacientes que no tengan cirrosis hepática y se hayan recuperado de una hepatitis B o C anterior podrán participar en el
    estudio. En caso de infección por el virus de la hepatitis C, podrán participar los pacientes que hayan presentado una respuesta virológica mantenida (RVM) durante al menos 12 semanas después de finalizar el tratamiento contra la hepatitis C
    -Infección aguda que precisa antibióticos orales en las 2semanas previas o antibióticos parenterales en las 4 semanas previas a 1ªadministración del fármaco del estudio (día 0)
    -Otra infección grave, en opinión del investigador, en los 6 meses previos a 1ªadministración del fármaco del estudio (día 0)
    -Otra infección crónica o recurrente, en opinión del investigador, en las 6semanas previas a 1ªadministración del fármaco del estudio (día 0)
    -Infecciones granulomatosas u oportunistas pasadas o presentes (p. ej., herpes zóster, infección por citomegalovirus o Pneumocystis carinii, aspergilosis o infección por micobacterias distintas de las de la TB) o micosis invasora (p. ej., histoplasmosis)
    7.Presentar uno o más de los problemas médicos siguientes:
    -Diagnóstico de CU o colitis indeterminada
    -Resección amplia del colon (colectomía subtotal o total) antes de 1ªadministración del fármaco del estudio (día 0)
    -Haberse sometido a más de tres procedimientos de resección del intestino delgado antes de 1ªadministración del fármaco del estudio (día 0)
    -Diagnóstico de síndrome del intestino corto
    -Signos de estenosis fija sintomática u obstrucción del intestino grueso o delgado
    -Necesidad actual o prevista de intervención quirúrgica para la EC durante el estudio
    -Paciente con fístula enterovesical, enterorretroperitoneal, enterocutánea y enterovaginal activa en los 6meses previos a 1ªadministración del fármaco del estudio(día 0). Se permiten fístulas enteroenterales sin síntomas clínicos de importancia en opinión del investigador y fístulas anales
    sin problemas de supuración
    -Estoma (p. ej., ileostomía o colostomía) en los 6 meses previos a 1ªadministración del fármaco del estudio (día 0)
    -Signos de infección por patógenos entéricos o presencia de huevos o parásitos patógenos o toxina de Clostridium difficile en los 6 meses previos a 1ª administración del fármaco del estudio(día 0)
    -Índice de masa corporal ≥ 35 kg/m2
    -Diabetes mellitus no controlada, incluso después del tratamiento con insulina
    -Hipertensión arterial no controlada (definida como una presión arterial sistólica ≥ 160 mmHg o una presión arterial diastólica ≥ 100 mmHg)
    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
    -Remisión clínica en la semana 54, definida como una puntuación CDAI absoluta menor de 150 puntos
    -Respuesta endoscópica en la semana 54, definida como una disminución de la puntuación SES-CD del 50% con respecto al valor basal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endopoint evaluation will be conducted at Week 54.
    La evaluación del criterio de valoración principal se llevará a cabo en la semana 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 52 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, and within 15 minutes after the end of the study drug infusion of Week 6.
    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
    • Any time between 120 hours and 168 hours after study drug administration of Week 22
    • Pre-dose of Week 24
    Pharmacodynamic Assessments:
    • Fecal calprotectin
    • C-reactive protein (CRP)
    Usability Assessments:
    The following Usability endpoints for PFS or AI will be assessed only for self-injected patients.
    • Usability for PFS as assessed by patient rating using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Weeks 14, 16, 18, 20, and 22.
    • Usability for AI as assessed by patient rating using PRE- and POST-SIAQ at Weeks 56, 58, 60, and 62.
    • The observer rating of successful self-injection for PFS using the Self-Injection Assessment Checklist at Week 14 and 22.
    • The observer rating of successful self-injection for AI using the Self-Injection Assessment Checklist at Weeks 56 and 62.
    Safety Assessments:
    Safety assessments will be performed on immunogenicity, hypersensitivity monitoring, vital sign measurements, weight, 12-lead ECGs, monitoring of TB signs and symptoms, monitoring of cardiovascular disease related signs and symptoms, chest X ray, IGRA, hepatitis B and C and HIV-1 and -2 status, NYHA functional classification assessment, diabetes mellitus, stool microbiology, physical examination findings, AEs, AEs of special interest (infusion-related reaction/systemic injection reaction, infection, delayed hypersensitivity, localized injection site reaction, malignancy), monitoring of drug-induced liver injury, pregnancy testing, clinical laboratory analyses, local site pain using 100 mm Visual Analogue Scale, and prior and concomitant medications.
    In case of delayed hypersensitivity including serum sickness-like reactions, the following assessments will be additionally performed to determine serum sickness during the study period:
    • Immunogenicity
    • Clinical laboratory analyses
    • Complement (C3, C4) and total hemolytic complement
    Criterios valoración secundarios fundamentales:
    -Respuesta CDAI-100 en sem54, definida como disminución de puntuación CDAI de100 puntos o más vs valor basal
    -Remisión clínica en sem54,definida como puntuación diaria media del peor dolor abdominal ≤ 1(en una escala de 4puntos) y puntuación media de frecuencia de deposiciones sueltas o líquidas ≤ 3(tipo 6 o 7escala BSFS)sin empeoramiento de ninguna de las puntuaciones vs valor basal
    -Remisión sin corticoides en sem54,definida por estar en remisión clínica(puntuación absoluta del CDAI basal<150) y, pacientes que recibían corticosteroides orales en momento basal,no haber recibido tratamiento oral con corticosteroides durante al menos 8sem anteriores a sem54
    -Remisión endoscópica en sem54,definida como puntuación SES-CD absoluta ≤4 con reducción de al menos 2puntos vs valor basal y ninguna subpuntuación >1
    Otros criterios de valoración secundarios:
    -Remisión clínica,definida como puntuación CDAI absoluta <150
    -Mantenimiento de remisión clínica en sem54, definida como puntuación CDAI<150 puntos,entre los pacientes en remisión clínica en sem10
    -Remisión clínica mantenida en sem22y54,definida como puntuación media del peor dolor abdominal diario ≤ 1(escala de 4puntos) y puntuación media de frec de deposiciones sueltas o líquidas ≤ 3(tipo 6 o 7 escala BSFS)en sem22y54 sin empeoramiento de ninguna de las puntuaciones vs valor basal
    -Respuesta CDAI-70,definida como disminución de puntuación CDAI de70puntos o más vs valor basal
    -Respuesta CDAI-100,definida como disminución de puntuación CDAI de100puntos o más vs valor basal
    -Mantenimiento de respuesta clínica en sem54,definida como respuesta CDAI-100 en sem54,entre pacientes con respuesta CDAI-100 en sem10.
    -Respuesta clínica mantenida en sem22y54,definida como reducción vs valor basal de puntuación diaria media del peor dolor abdominal(escala 4puntos) o frecuencia diaria media de deposiciones sueltas o líquidas (tipo 6 o 7escala BSFS)en sem22y54
    -Remisión endoscópica, definida como puntuación SES-CD absoluta ≤4 con reducción de al menos 2puntos vs al valor basal y ninguna subpuntuación >1
    -Respuesta endoscópica, definida como disminución del 50% de puntuación SES-CD vs valor basal
    -Escala global del paciente, definida como pregunta al paciente sobre su opinión acerca de si ha logrado remisión de síntomas deEC(sí o no).
    -Cuest abreviado de enfermedad inflamatoria intestinal (SIBDQ)
    Evaluaciones FC:
    Todos los pacientes,Cmín se evaluará hasta sem52 y Cmáx se evaluará en sem6.Se obtendrán muestras de sangre para análisis FC antes de administ de sem 0,2,6,10,14,22,30,38,46,54 y en los 15min siguientes al final de infusión del fármaco del estudio de sem6.Pacientes que acepten recogida de más muestras de sangre,se obtendrán muestras de sangre adicionales para análisis de FC poblacional en:
    -Cualquier momento entre 48y72horas después de administ del fármaco del estudio de sem22
    -Cualquier momento entre 120 y 168horas después de administ del fármaco del estudio de sem22
    -Antes de administ de sem24
    Evaluaciones FD:
    -Calprotectina fecal
    -Proteína C reactiva(PCR)
    Evaluaciones manejabilidad:
    Los siguientes criterios de valoración de manejabilidad de JPC o el AI se evaluarán únicamente en pacientes que se autoinyecten
    -Manejabilidad de JPC,evaluada por propio paciente mediante cuest de eval. de autoinyección (SIAQ) PRE y POST en sem14,16,18,20 y22
    -Manejabilidad del AI, evaluada por paciente mediante los cuest SIAQ-PRE y POST en semanas 56,58,60 y 62.
    -Valoración por parte del observador de autoinyección satisfactoria con JPC mediante lista de comprobación de autoinyección en sem14y22
    -Valoración por parte del observador de autoinyección satisfactoria con el AI mediante lista de comprobación de autoinyección en sem56y62
    Evaluaciones de seguridad:
    Con análisis de inmunogenicidad,vigilancia de reacciones de hipersensibilidad,determinación de constantes vitales,peso,ECG 12derivaciones,vigilancia de signos y síntomas de TB,vigilancia de signos y síntomas relacionados con enfermedad cardiovascular,radiografía de tórax, ALIG,estado de hepatitis B y C y de VIH 1 y 2,evaluación de clase funcional de NYHA,diabetes mellitus, microbiología fecal, hallazgos de la exploración física, AA,AA de interés especial(reacciones relacionadas con infusión/reacciones sistémicas a inyección,infecciones,hipersensibilidad tardía, reacciones localizadas en el lugar de inyección,neoplasias malignas),vigilancia de lesiones hepáticas inducidas por fármacos, prueba de embarazo,análisis clínicos de laborat,dolor localizado en el lugar de administración utilizando escala analógica visual de100mm,y medicamentos previos y concomitantes
    En caso de hipersensibilidad tardía,incluidas reacciones de tipo enfermedad del suero,se harán las evaluaciones siguientes para detectar presencia de enfermedad del suero durante el período del estudio:
    -Inmunogenicidad
    -Pruebas analíticas
    -Complemento(C3,C4)y complemento hemolítico total
    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).
    Criterios valoración secundarios fundamentales se llevaran a cabo en la semana 54 y otros criterios valoración secundarios se llevaran a cabo según los tiempos descritos en el protocolo. FC, FD y evaluaciones de seguridad se realizarán según los plazos especificados en el calendario de eventos (Tabla 10-1 y 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belarus
    Brazil
    Bulgaria
    Chile
    Croatia
    Czech Republic
    Estonia
    France
    Georgia
    Germany
    Greece
    Hungary
    India
    Ireland
    Israel
    Italy
    Latvia
    Mexico
    Moldova, Republic of
    Peru
    Poland
    Portugal
    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
    UVUP
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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: 570
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 261
    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.
    Los pacientes pasarán al tratamiento estándar local si así lo requiere el investigador.
    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 Decision2019-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-31
    P. End of Trial
    P.End of Trial StatusCompleted
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