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    Summary
    EudraCT Number:2018-004002-25
    Sponsor's Protocol Code Number:CNTO1959UCO3001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-09-04
    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 number2018-004002-25
    A.3Full title of the trial
    A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis
    Estudio fase 2b/3 aleatorizado, doble-ciego, controlado con placebo, grupo paralelo, multicéntrico, para evaluar la Eficacia y Seguridad de Guselkumab en pacientes con Colitis Ulcerosa activa de moderada a severa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis
    Un estudio de la Eficacia y Seguridad de Guselkumab en pacientes con Colitis Ulcerosa activa de moderada a severa.
    A.3.2Name or abbreviated title of the trial where available
    QUASAR
    QUASAR
    A.4.1Sponsor's protocol code numberCNTO1959UCO3001
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Cilag, S.A.
    B.5.2Functional name of contact pointGlobal Clinical Operations Spain
    B.5.3 Address:
    B.5.3.1Street AddressPº Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+34672603548
    B.5.5Fax number+34917228628
    B.5.6E-mailcalvare@its.jnj.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 nameguselkumab
    D.3.2Product code CNTO1959
    D.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    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 INNGUSELKUMAB
    D.3.9.2Current sponsor codeCNTO 1959
    D.3.9.4EV Substance CodeSUB179789
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    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 nameguselkumab
    D.3.2Product code CNTO1959
    D.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    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 INNGuselkumab
    D.3.9.2Current sponsor codeCNTO 1959
    D.3.9.4EV Substance CodeSUB179789
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    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.3.1Product nameguselkumab
    D.3.2Product code CNTO1959
    D.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    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 INNGuselkumab
    D.3.9.2Current sponsor codeCNTO 1959
    D.3.9.4EV Substance CodeSUB179789
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    D.IMP: 4
    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 nameguselkumab
    D.3.2Product code CNTO1959
    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 INNGuselkumab
    D.3.9.2Current sponsor codeCNTO 1959
    D.3.9.4EV Substance CodeSUB179789
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    D.IMP: 5
    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 nameguselkumab
    D.3.2Product code CNTO1959
    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 INNGuselkumab
    D.3.9.2Current sponsor codeCNTO 1959
    D.3.9.4EV Substance CodeSUB179789
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    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/infusion in pre-filled syringe
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    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 Ulcerative Colitis
    Colitis Ulcerosa activa de moderada a severa.
    E.1.1.1Medical condition in easily understood language
    Inflammation of Digestive Tract
    Inflamación del tracto digestivo.
    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
    To evaluate the efficacy and safety of guselkumab in moderately to severely active UC.
    Evaluar la Eficacia y Seguridad de Guselkumab en pacientes con Colitis Ulcerosa activa de moderada a severa.
    E.2.2Secondary objectives of the trial
    - To evaluate the impact of guselkumab on health-related quality of life (HRQoL) and health economics outcome measures.
    - To evaluate the PK, immunogenicity, and pharmacodynamics (PD) of guselkumab therapy, including changes in C-reactive protein (CRP) and fecal calprotectin.
    - Evaluar la repercusión de guselkumab en la calidad de vida relacionada con la salud (CdVRS) y los indicadores de economía sanitaria.
    - Evaluar la farmacocinética (FC), la inmunogenicidad y la farmacodinamia (FD) del tratamiento de guselkumab, incluidos los cambios en la proteína C reactiva (PCR) y la calprotectina fecal
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional pharmacogenomic substudy
    Subestudio farmacogenómico opcional.
    E.3Principal inclusion criteria
    1. Male or female, 18 years of age or older
    2. Documented diagnosis of UC at least 3 months before screening
    3. Moderately to severely active UC as defined by baseline modified Mayo score
    4. History of inadequate response to or failure to tolerate conventional or advanced therapy as defined in the protocol
    5. Screening laboratory test results within the study protocol defined parameters

    Please see section 5.1 in the protocol for all inclusion criteria.
    1. Varón o mujer de 18 años de edad o más.
    2. Diagnóstico confirmado (histológicamente y endoscópicamente o radiográficamente) de CU al menos 3 meses antes de la selección. Se debe disponer de un informe de biopsia que respalde el diagnóstico en los documentos fuente.
    3. CU activa de moderada a grave, definida como un Índice de Mayo modificado inicial (Semana I-0) de 4 a 9, inclusive, utilizando la subpuntuación endoscópica de Mayo obtenida durante la revisión central de la video-endoscopia.
    4. Subpuntuación de Mayo de hemorragia rectal de ≥1 en la visita basal.
    5. Endoscopia de selección con subpuntuación de endoscopia de la puntuación de Mayo ≥2 en la obtenida durante la revisión central de la video-endoscopia.
    6. Un participante con colitis extensiva durante ≥8 años o enfermedad limitada al lado izquierdo del colon durante ≥10 años que debe haberse sometido a una colonoscopia completa para evaluar la presencia de displasia 1 año antes de la primera dosis de tratamiento del estudio o a una colonoscopia completa para evaluar la presencia de neoplasia maligna en la visita de selección.
    7. Un participante ≥45 años de edad debe haberse sometido a una colonoscopia completa para evaluar la presencia de pólipos adenomatosos en los 5 años anteriores a la primera dosis de tratamiento del estudio o a una colonoscopia completa para evaluar la presencia de pólipos adenomatosos en la visita de selección. Los pólipos adenomatosos se deben extirpar antes de la primera dosis de tratamiento del estudio.
    Tratamientos médicos concomitantes o previos recibidos
    8. Un participante debe:
    a. Haber fracasado a terapia avanzada, es decir, haber recibido tratamiento con 1 o más antagonistas de TNFα, vedolizumab o tofacitinib en una dosis aprobada para el tratamiento de la CU, y tener antecedentes documentados de respuesta inadecuada o intolerancia al tratamiento según se define en el apéndice 2 (apartado 10.2) y el apéndice 3 (apartado 10.3);
    O
    b.No haber recibido terapia avanzada (es decir, antagonistas de TNFα, vedolizumab o tofacitinib) o no haber presentado antecedentes de respuesta inadecuada o intolerancia a terapia avanzada y tener antecedentes previos o actuales de haber recibido medicación para la CU que incluye al menos 1 de los siguientes:
    1) Respuesta insuficiente o intolerancia al tratamiento actual con corticosteroides o inmunomoduladores orales (6-MP o AZA) según se define en el apéndice 4 (apartado 10.4).
    O
    2) Antecedentes de respuesta inadecuada o intolerancia a al menos 1 de los siguientes tratamientos: corticosteroides o inmunomoduladores orales o i.v. (6-MP o AZA) según se define en el apéndice 4 (apartado 10.4).
    O
    3) Antecedentes de dependencia a los corticosteroides (es decir, incapacidad de reducir con éxito la dosis de corticosteroides sin que reaparezcan los síntomas de CU) según se define en el apéndice 4 (apartado 10.4).
    9. Antes de recibir la primera dosis de tratamiento del estudio, se deben cumplir las siguientes condiciones:
    a. Si está recibiendo inmunomoduladores convencionales (AZA, 6-MP o MTX), se deben haber administrado durante ≥12 semanas y en una dosis estable durante al menos 4 semanas.
    b. Si se ha interrumpido recientemente la administración de AZA, 6-MP o MTX, se debe haber suspendido al menos durante 4 semanas.
    c. Si está recibiendo compuestos orales de 5-ASA, la dosis debe haber sido estable durante al menos 2 semanas.
    d. Si está recibiendo corticosteroides orales, distintos de budesonida o dipropionato de beclometasona, la dosis debe ser ≤20 mg/día de prednisona o su equivalente y debe haber sido estable durante al menos 2 semanas.
    e. Si está recibiendo budesonida o dipropionato de beclometasona, la dosis debe haber sido estable durante al menos 2 semanas.
    f. Si se ha interrumpido recientemente la administración de compuestos orales de 5-ASA o corticosteroides orales, se debe haber suspendido al menos durante 2 semanas.
    10. Los siguientes medicamentos/tratamientos deben haberse suspendido antes de recibir la primera dosis de tratamiento del estudio:
    a. Vedolizumab durante al menos 12 semanas.
    b.Tofacitinib y otros inhibidores de JAK durante al menos 2 semanas o 5 vidas medias lo que sea más prolongado.
    c. Tratamiento con antagonistas de TNFα (p. ej., infliximab, adalimumab o golimumab [o biosimilares aprobados para estos tratamientos]) durante al menos 8 semanas.
    d. Ciclosporina, micofenolato mofetilo, tacrolimus o sirolimus durante al menos 4 semanas.
    e. Se debe haber suspendido el uso de 6-tioguanina durante al menos 4 semanas.
    f. Corticosteroides rectales (es decir, corticosteroides administrados en el recto o colon sigmoide en forma de espuma, enema o supositorio) durante al menos 2 semanas.
    g. ...
    Por favor, refiérase a la sección 5.1 del protocolo para consultar todos los criterios de inclusión.
    E.4Principal exclusion criteria
    1. Severe extensive colitis as defined in the study protocol
    2. UC limited to the rectum only
    3. Presence of a stoma
    4. Presence or history of a fistula
    5. Presence of symptomatic colonic or small bowel obstruction
    6. History of extensive colonic resection
    7. History of colonic mucosal dysplasia
    8. Indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease.

    Please see section 5.2 in the protocol for all exclusion criteria.
    1.Colitis extensiva grave demostrada mediante:
    a.Hospitalización actual para el tratamiento de la CU.
    O
    b.Opinión del investigador de que el participante puede necesitar una colectomía en las 12 semanas siguientes a la visita basal del estudio.
    O
    c.Complejo de síntomas en las visitas de selección o basal que incluye al menos 4 de los siguientes:
    1)Diarrea con ≥6 movimientos intestinales/día con sangre macroscópica en las heces
    2)Sensibilidad abdominal grave o de rebote focal
    3)Fiebre persistente (temperatura ≥38 °C)
    4)Taquicardia (>100 latidos/minuto)
    5)Anemia (hemoglobina <8,5 g/dl)
    2.CU limitada solo al recto o a <20 cm del colon.
    3.Presencia de estoma.
    4.Presencia o antecedentes de fístula.
    5.Precisar, o haber precisado en los 2 meses anteriores a la selección, una cirugía para una hemorragia gastrointestinal activa, peritonitis, obstrucción intestinal o absceso intraabdominal o pancreático que requiera drenaje quirúrgico, u otras afecciones que pudieran confundir la evaluación del beneficio del tratamiento del estudio.
    6.Presencia de obstrucción del colon o del intestino delgado sintomática, confirmada por la evidencia objetiva radiográfica o endoscópica de una estenosis con obstrucción resultante (dilatación del colon o del intestino delgado proximal a la estenosis en la radiografía de bario o incapacidad de atravesar la estenosis en la endoscopia).
    7.Antecedentes de resección colónica extensa (p. ej., quedan menos de 30 cm de colon) que impediría una evaluación adecuada del efecto del tratamiento del estudio sobre la actividad clínica de la enfermedad.
    8.Antecedentes de displasia de la mucosa del colon. No se excluirá a los participantes del estudio debido a un hallazgo patológico de «indefinido para displasia con atipia reactiva».
    9.Presencia de pólipos colónicos adenomatosos en la endoscopia de selección, si no se extirparon antes de la inclusión en el estudio, o antecedentes de pólipos colónicos adenomatosos que no se extirparon.
    10.Diagnóstico de colitis indeterminada, colitis microscópica, colitis isquémica o enfermedad de Crohn, o hallazgos clínicos que sugieren enfermedad de Crohn.
    11.Cultivo de heces u otra prueba positiva para un patógeno entérico, incluida la toxina Clostridium difficile, en los 4 meses anteriores a la primera dosis de tratamiento del estudio, a menos que la prueba sea repetida con resultado negativo y no haya signos de infección en curso con ese patógeno.
    Tratamientos médicos simultáneos o previos recibidos
    12.Ha recibido por prescripticón médica los siguientes medicamentos o tratamientos:
    a.Tratamiento biológico dirigido a IL-12 y/o IL-23 (por ejemplo, ustekinumab, briakinumab, guselkumab, mirikizumab, tildrakizumab, brazikumab o risankizumab).
    b.Natalizumab en los 12 meses posteriores a la primera dosis de tratamiento del estudio.
    c.Agentes que reducen los linfocitos B o T (p. ej., rituximab, alemtuzumab) en los 12 meses posteriores a la primera dosis de tratamiento del estudio o continúan manifestando una reducción de los linfocitos B o T más de 12 meses después de finalizar el tratamiento con agentes que provocan la disminución de linfocitos.
    d.Cualquier medicamento/tratamiento en investigación en las 4 semanas anteriores a la primera dosis de tratamiento del estudio o en el plazo de 5 vidas medias del agente en investigación, lo que sea más prolongado.
    e.Aféresis (p. ej., aféresis con Adacolumn o Cellsorba) en las 2 semanas anteriores a la primera dosis de tratamiento del estudio.
    Infecciones o predisposición a tener infecciones
    13.Antecedentes de infección granulomatosa latente o activa, como la histoplasmosis o la coccidioidomicosis, antes de la selección. Consulte el criterio de inclusión 12 para obtener más información acerca de las posibilidades de participar con antecedentes de tuberculosis latente.
    14.Antecedentes de enfermedad infecciosa crónica o recurrente o en curso, entre las que se incluyen, entre otras, infecciones sinopulmonares recurrentes, bronquiectasia, infecciones renales/urinarias recurrentes (p. ej., pielonefritis recurrente, cistitis recurrente), heridas o úlceras cutáneas abiertas, supurantes o infectadas.
    15.Radiografía de tórax en las 12 semanas anteriores a la primera dosis de tratamiento del estudio que muestre una anomalía que indica una neoplasia maligna o una infección activa actual, incluida la tuberculosis.
    16.Antecedentes de virus de la inmunodeficiencia humana (VIH) con anticuerpos positivos o pruebas positivas para VIH en la selección.

    Por favor, refiérase a la sección 5.2 del protocolo para consultar todos los criterios de exclusión.
    E.5 End points
    E.5.1Primary end point(s)
    Induction study 1:
    Clinical response at Week 12

    Induction study 2:
    Clinical remission at Week 12

    Maintenance study:
    Clinical remission at Week 52
    Estudio de inducción 1:
    Respuesta clínica en semana 12.

    Estudio de inducción 2:
    Remisión clínica en la semana 12.

    Estudio de mantenimiento:
    Remisión clínica en la semana 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    Maintenance study
    · Symptomatic remission at Week 52
    · Endoscopic healing at Week 52
    · Corticosteroid-free clinical remission at Week 52
    · Clinical response at Week 52
    · Histo-endoscopic healing at Week 52
    · Clinical remission at Week 52 among the participants who had achieved clinical remission at maintenance baseline
    Estudio de mantenimiento:
    •Remisión sintomática en la semana M-52.
    •Cicatrización endoscópica en la semana M-52.
    •Remisión clínica sin corticosteroides (es decir, sin necesidad de tratamiento con corticosteroides durante al menos 8 semanas antes) en la semana M-52.
    •Respuesta clínica en la semana M-52.
    •Cicatrización histo-endoscópica en la semana M-52.
    •Remisión clínica en la semana M-52 entre los participantes que habían logrado la remisión clínica al inicio del mantenimiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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) Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA103
    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
    Argentina
    Australia
    Belgium
    Bulgaria
    Canada
    China
    Czech Republic
    France
    Germany
    Hong Kong
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Malaysia
    Netherlands
    Poland
    Portugal
    Russian Federation
    Spain
    Sweden
    Taiwan
    Thailand
    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
    LVLS
    Última visita del último paciente (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 months2
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days22
    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: 900
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 435
    F.4.2.2In the whole clinical trial 1000
    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)
    Participants should return to their primary physician to determine standard of care.
    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 Decision2020-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-21
    P. End of Trial
    P.End of Trial StatusOngoing
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