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    Summary
    EudraCT Number:2018-004346-42
    Sponsor's Protocol Code Number:3150-301-008
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-11-11
    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 number2018-004346-42
    A.3Full title of the trial
    A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease
    Estudio de fase IIb/III, doble ciego, multicéntrico, aleatorizado, de doble simulación, controlado con placebo y fármaco activo, con grupos paralelos e ininterrumpido de 52 semanas de duración para evaluar la eficacia y la seguridad de brazikumab en participantes con enfermedad de Crohn activa de moderada a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease
    Estudio controlado con placebo y fármaco active de brazikumab en participantes con enfermedad de Crohn activa de moderada a grave
    A.3.2Name or abbreviated title of the trial where available
    52-Week Phase 2b/3 Crohn’s Disease Study
    Estudio de fase IIb/III de 52 semanas de duración de la enfermedad de Crohn
    A.4.1Sponsor's protocol code number3150-301-008
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03759288
    A.5.4Other Identifiers
    Name:INDNumber:111,773
    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 SponsorAllergan Ltd.
    B.1.3.4CountryEuropean Union
    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 supportAllergan Sales LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Ltd.
    B.5.2Functional name of contact pointCTRG
    B.5.3 Address:
    B.5.3.1Street Address1st Floor, Marlow International, The Parkway
    B.5.3.2Town/ cityMarlow, Buckinghamshire
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailML-CTRG@Allergan.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 nameBrazikumab
    D.3.2Product code Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
    D.3.4Pharmaceutical form Solution for injection/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 INNBRAZIKUMAB
    D.3.9.1CAS number 1610353-18-8
    D.3.9.3Other descriptive nameAnti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
    D.3.9.4EV Substance CodeSUB188673
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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 RoleComparator
    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 Humira®
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 No
    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 nameBrazikumab
    D.3.2Product code Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
    D.3.4Pharmaceutical form Solution for injection/infusion
    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 INNBRAZIKUMAB
    D.3.9.1CAS number 1610353-18-8
    D.3.9.3Other descriptive nameAnti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
    D.3.9.4EV Substance CodeSUB188673
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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
    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
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn's Disease
    Enfermedad de Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn's disease is a disease that causes the intestines to become swollen and may develop ulcers
    La enfermedad de Crohn es una enfermedad que produce la inflamación de los intestinos y puede desarrollar úlceras
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10011402
    E.1.2Term Crohn's disease (colon)
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Stage 1: To compare the efficacy of brazikumab with that of placebo to achieve endoscopic response and clinical remission at Week 12

    Stage 2: To compare the efficacy of brazikumab with that of Humira® to achieve endoscopic response and clinical remission at Week 52 in participants who are BM+
    Etapa 1: Comparar la eficacia de brazikumab con la del placebo para conseguir una respuesta endoscópica y remisión clínica en la semana 12.

    Etapa 2: Comparar la eficacia de brazikumab con la de Humira® para conseguir una respuesta endoscópica y remisión clínica en la semana 52 en los participantes BM+.
    E.2.2Secondary objectives of the trial
    Stage 1:
    To compare the efficacy of brazikumab with that of placebo to achieve sustained endoscopic response and clinical remission at both Wk12 and Wk52
    To compare the efficacy of brazikumab with that of placebo to achieve endoscopic remission and clinical remission at Wk52
    To compare the efficacy of brazikumab with that of placebo to achieve endoscopic response at Week 12 and endoscopic remission at Wk52 and clinical remission at both Wk12 and Wk52
    Stage 2:
    To compare the efficacy of brazikumab with that of Humira® to achieve sustained endoscopic response and clinical remission at both Wk12 and Wk52 in participants who are BM+
    To compare the efficacy of brazikumab with that of Humira® to achieve endoscopic remission and clinical remission at Wk52 in participants who are BM+
    To compare the efficacy of brazikumab with that of Humira® to achieve CS free (for the last 12 wks before the assessment at Wk 52) endoscopic and clinical remission at Wk 52 in participants who are BM+
    Etapa1
    Comparar la eficacia de brazikumab con la del placebo para conseguir respuesta endoscópica y remisión clínica prolongadas en la sem 12 y 52
    Comparar la eficacia de brazikumab con la del placebo para conseguir una respuesta endoscópica y remisión clínica en la sem 52
    Comparar la eficacia de brazikumab con la del placebo para conseguir respuesta endoscópica en la sem 12 y remisión endoscópica en la sem 52 y remisión clínica en la sem 12 y 52
    Etapa 2
    Comparar eficacia de brazikumab con la de Humira para conseguir respuesta endoscópica y remisión clínica prolongadas en la sem 12 y 52 en los participantes BM+
    Comparar leficacia de brazikumab con la de Humira para conseguir remisión endoscópica y remisión clínica en la sem 52 en los participantes BM+
    Comparar eficacia de brazikumab con la de Humira para conseguir remisión endoscópica y remisión clínica sin corticoesteroides (en las 12 últimas semanas antes de la evaluación de la sem 52) en la sem 52 en los participantes BM+
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged 16 to 80 years, inclusive, or minimum age of adult consent according to local regulations, at Screening. For participants less than 18 years of age, the participant must weigh at least 40 kg at Screening.
    2. Diagnosis of ileal, ileocolonic, or colonic CD with an onset of symptoms for a minimum of 3 months prior to Screening as determined by the investigator based on clinical history, exclusion of other etiologies including infectious causes, and characteristic endoscopic and/or histologic findings.
    3. Moderately to severely active CD
    4. Participant had an inadequate response or intolerance to intervention with oral aminosalicylates, oral CS, azathioprine, methotrexate, or 6-mercaptopurine, or demonstrated CS dependence for the treatment of CD.
    5. Participants taking 5-aminosalicylates, Oral prednisone (or equivalent), Budesonide, Immunomodulators, Oral antibiotics, Probiotics must be at a stable dose.
    6. Meets the following TB criteria: Participant has no known history of active TB; Participant has no known history of latent TB without completion of an appropriate course of intervention or is presently taking appropriate ongoing prophylactic intervention; Meets 1 of the following acceptable TB test results: Negative QFT-TB obtained from central laboratory within 4 weeks prior to randomization or For a positive QFT-TB test obtained during Screening from the central laboratory, active TB must be ruled out or Indeterminate QFT-TB test obtained during the Screening period from the central laboratory with ongoing QFT-TB testing; A negative tuberculin skin test is required if the QFT-TB test is not approved/registered in that country; Participants with a history of using anti-TNFα agents for a treatment course of 1 year or longer who have discontinued an anti-TNFα agent within 6 months prior to Screening must obtain a chest x-ray showing no evidence of active TB within 8 weeks prior to Screening or during Screening.
    7. Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 acceptable methods of contraception from Screening.
    8. Female participants who are post-menopausal and of non-childbearing potential must have an elevated FSH at or above the range for post-menopausal women by the central laboratory during Screening.
    9. Nonsterilized males who are sexually active with a female partner of childbearing potential must comply with the methods of contraception
    10. Ability to provide written informed consent prior to any study procedures
    11. Willingness and ability to attend all study visits, comply with the study procedures, read and write in order to complete questionnaires, and be able to complete the study period
    1. Entre 16 y 80 años de edad, ambos incluidos, o edad mínima para consentimiento adulto conforme a las normativas locales, en la selección. Para participantes menores de 18 años, el participante debe pesar al menos 40 kg en la selección.
    2. Diagnóstico de EC del íleon, íleon-colon o colon, cuyos síntomas hayan comenzado al menos tres meses antes de la selección, según determine el investigador sobre la base de la historia clínica, exclusión de otras etiologías incluidas las causas infecciosas y observaciones endoscópicas o histológicas características.
    3. EC moderada a gravemente activa
    4. El participante ha presentado una respuesta insuficiente o intolerancia a la intervención con aminisalicilatos orales, corticoesteroides orales, azatioprina, metotrexato o 6-mercaptopurina o dependencia de corticoesteroides para el tratamiento de la EC
    5. Participantes tomando 5-aminosalicilatos, prednisona oral (o equivalente), budesonide, Inmunomoduladores, antibióticos orales, probioticos, deben estar a una dosis estable
    6. Cumple los siguientes criterios de TB: el participante no tiene antecedentes conocidos de TB activa; el participante no tiene antecedentes conocidos de TB latente sin realizar un ciclo apropiado de intervención ni está recibiendo actualmente una intervención profiláctica apropiada en curso; cumple uno de los siguientes resultados de prueba de TB aceptables: QFT-TB negativo obtenido del laboratorio central en las 4 semanas previas a la aleatorización, o con una prueba QFT-TB positiva obtenida durante la selección del laboratorio central, debe descartarse la TB activa o una prueba QFT-TB indeterminada obtenida durante la selección del laboratorio central con una prueba QFT-TB en curso; si la prueba QFT-TB no está aprobada/registrada en ese país, será necesaria una prueba de tuberculina cutánea negativa; los participantes con antecedentes de uso de agentes anti-TNFα durante un ciclo de tratamiento de 1 año o más, que hayan discontinuado un agente anti-TNFα en los 6 meses previos a la selección, deben tener una radiografía de tórax que no muestre signos de TB en las 8 semanas previas a la selección o durante la selección.
    7. Las mujeres en edad fértil que sean sexualmente activas y tengan una pareja masculina no esterilizada deben usar 2 métodos anticonceptivos aceptables desde la selección.
    8. Las participantes posmenopáusicas y que no estén en edad fértil deben mostrar un aumento de FSH al mismo nivel o por encima del intervalo de las mujeres posmenopáusicas según los análisis del laboratorio central durante la selección.
    9. Los hombres no esterilizados y sexualmente activos que tengan una pareja femenina en edad fértil deben seguir los métodos anticonceptivos
    10. Capacidad para otorgar su consentimiento informado por escrito antes de que se realice cualquier procedimiento del estudio
    11. Disposición y capacidad para acudir a todas las visitas del estudio, cumplir con los procedimientos del estudio, leer y escribir para rellenar los cuestionarios y poder terminar el período del estudio.
    E.4Principal exclusion criteria
    1. Participant has previously received Humira® and was intolerant to treatment or had met the criteria for primary or secondary non-response to treatment:
    a. Primary non-response: Signs and symptoms of persistently active disease despite a history of at least 1 induction regimen of Humira® per the local label consisting of at least 2 doses at least 2 weeks apart
    b. Secondary non-response: Recurrence of symptoms of persistently active disease during scheduled maintenance dosing of Humira® per the local label following prior clinical benefit
    c. Intolerance: AE associated with discontinuation of Humira® therapy, including, but not limited to, hypersensitivity, infusion-related reaction, infection, or congestive heart failure
    2. Participant is unable or unwilling to have endoscopic procedures performed during the study.
    3. History or current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, colonic mucosal dysplasia, primary sclerosing cholangitis, or untreated bile acid malabsorption.
    4. History of toxic megacolon within 3 months prior to Baseline (Visit 2).
    5. Any intra-abdominal surgery, bowel resection, diversion, placement of ostomy or stoma within 3 months prior to Screening. Participants with a draining stoma are excluded.
    6. Participant has an enterocutaneous or entovesicular fistula. Participants with active fistulas may be considered if there is no anticipation for surgery and there is no evidence of active infection (eg, abscess) after further discussion with the study medical monitor.
    7. Bowel perforation during the 6 months prior to Screening or evidence of obstruction within 3 months of Screening.
    8. Complications of CD including short bowel syndrome, strictures/stenoses with obstruction or pre-stenotic dilation, or conditions where surgery may be anticipated within 6 months, or other conditions that may confound efficacy evaluations for the study.
    9. Participant has any non-passable colonic stenosis/narrowing identified during the qualifying ileocolonoscopy (successful endoscope passage to the caecum with inability to enter the endoscope into the ileum is not covered under this exclusion criterion, and does not require exclusion).
    10. Ongoing nutritional dependency for total parenteral nutrition or an elemental diet at Screening.
    11. Participant has any of the following related to infections:
    a. Evidence of a recent (within 6 months of Baseline [Visit 2]) systemic fungal infection, requiring inpatient hospitalization, and/or antifungal treatment. Participants treated for localized fungal infections (eg, oral, vaginal, and skin candidiasis, onychomycosis) are not excluded.
    b. Any infection requiring hospitalization or treatment with IV anti-infectives (including anti-viral treatment) within 4 weeks of Screening
    c. Cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 8 weeks prior to Screening
    d. Clinically significant chronic infection (eg, osteomyelitis) that has not resolved within 8 weeks of Screening
    e. Non-serious infection requiring oral anti-infectives within 2 weeks prior to randomization must be further discussed with the study medical monitor. Chronic suppressive antiviral treatment for herpes simplex virus in the absence of active lesions or uncomplicated urinary tract infections are not considered exclusionary.
    f. Participant has clinical evidence of or suspected to have an abscess during Screening. Cutaneous and perianal/perirectal abscesses are not exclusionary if drained and adequately treated at least 3 weeks prior to Screening.
    g. Diagnosis of peritonitis or receiving treatment for peritonitis within 8 weeks prior to Screening
    h. Participant has any underlying condition that predisposes participant to infections
    12. Previous allogenic bone marrow transplant or history of organ or cell-based transplantation (eg, islet cell transplantation or autologous stem cell transplantation) with the exception of corneal transplant.
    13. Chronic hepatitis B or C infection, TB, or C. difficile-positive at Screening (Visit 1).
    14. Known history of primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection, including HIV infection. Participants with positive results of HIV testing by the central laboratory will be excluded.
    15. Prior history of or current diagnosis of a demyelinating disorder.

    All exclusion criteria cannot be list in this field, please refer to the section 5.2 of the protocol
    1. El participante ha recibido previamente Humira® y no toleró el tratamiento o cumplía los criterios de no respuesta principal o secundaria al tratamiento:
    a. Ausencia de respuesta primaria: Signos y síntomas de enfermedad persistentemente activa pese a los antecedentes de al menos un régimen de inducción con Humira® según el prospecto local que consiste en al menos 2 dosis a intervalos de al menos 2 semanas.
    b. Ausencia de respuesta secundaria: Recurrencia de síntomas de enfermedad activa persistentemente durante las dosis de mantenimiento de Humira® programadas según el prospecto local tras un beneficio clínico previo.
    c. Intolerancia: AA asociados a la interrupción de la terapia con Humira®, incluidos entre otros, hipersensibilidad, reacción relacionada con la infusión, infección o insuficiencia cardíaca congestiva.
    2. El participante no puede o no desea someterse a un procedimiento endoscópico durante el estudio.
    3. Antecedentes o diagnóstico actual de colitis ulcerosa, colitis indefinida, colitis microscópica, colitis isquémica, displasia de la mucosa del colon, colangitis esclerosante primaria o malabsorción de ácido biliar no tratada.
    4. Antecedentes de megacolon tóxico en los 3 meses anteriores al período inicial (visita 2).
    5. Cualquier cirugía intraabdominal, resección intestinal, desviación, colocación de ostomía o estoma en los 3 meses anteriores a la selección. Se excluye a los participantes con un estoma con drenaje.
    6. El participante tiene una fístula enterocutánea o enterovesicular. Podrá considerarse a los participantes con fístulas activas si no se prevé cirugía y no hay signos de infección activa (p.ej., absceso) después de haberlo comentado más a fondo con el monitor médico del estudio.
    7. Perforación intestinal en los 6 meses previos a la selección o signos de obstrucción en los 3 meses anteriores a la selección.
    8. Complicaciones de la EC, como síndrome del intestino corto, estrechamientos/estenosis con obstrucción o dilatación preestenósica o patologías en las que se prevea cirugía en los 6 meses siguientes u otras patologías que puedan confundir las evaluaciones de eficacia para el estudio.
    9. El participante tiene alguna estenosis/estrechamiento de colon que no se puede sobrepasar, detectado durante la ileocolonoscopia de comprobación de requisitos (el paso con éxito de la endoscopia al ciego, con imposibilidad de introducir el endoscopio en el íleon no está cubierto en este criterio de exclusión y no requiere exclusión).
    10. Dependencia nutricional actual de nutrición parenteral o una dieta básica en la selección.
    11. El participante tiene alguna de las siguientes relacionadas con infecciones:
    a. Signos de infección fúngica reciente (en los 6 meses anteriores al período inicial [visita 2]) que requiera hospitalización del paciente o tratamiento antifúngico. No se excluye a los participantes tratados con infecciones fúngicas localizadas (p.ej., orales, vaginales y candidiasis cutánea, onicomicosis).
    b. Cualquier infección que requiera hospitalización o tratamiento con antiinfecciosos i.v. (incluido el tratamiento antivírico) en las 4 semanas anteriores a la selección.
    c. Infección por citomegalovirus o virus de Epstein-Barr no resuelta totalmente en las 8 semanas previas a la selección.
    d. Infección crónica clínicamente significativa (p.ej., osteomielitis) que no se haya resuelto en las 8 semanas anteriores a la selección.
    e. Una infección no grave que requiera antiinfecciosos orales en las 2 semanas previas a la aleatorización se comentará más a fondo con el monitor médico del estudio. No se considera excluyente el tratamiento antivírico supresor crónico para el virus del herpes simple en ausencia de lesiones activas o infecciones urinarias no complicadas.
    f. El participante presenta signos clínicos o se sospecha que tiene un absceso durante la selección. Los abscesos cutáneos y perianales/perirrectales no son excluyentes si se drenan y se tratan adecuadamente durante al menos 3 semanas antes de la selección.
    g. Diagnóstico de peritonitis o tratamiento para peritonitis en las 8 semanas anteriores a la selección.
    h. El participante tiene alguna patología de base que le predispone a infecciones.
    12. Trasplante de médula ósea alogénico previo o antecedentes de trasplante de órgano o células (p.ej., trasplante de células de islotes o trasplante autólogo de células madre) con la excepción del trasplante de córnea.
    13. Infección por hepatitis B o C crónica, TB o positivo para C. difficile en la selección (visita 1).
    14. Antecedentes conocidos de inmunodeficiencia primaria, esplenectomía o cualquier enfermedad de base que predisponga al paciente a infecciones, incluida la infección por el VIH. Se excluirá a los participantes con resultados positivos en la prueba del VIH según los análisis del laboratorio central.

    Todos los criterios de exclusión no pueden ser listados en este campo, por favor refiérase a la sección 5.2 del protocolo
    E.5 End points
    E.5.1Primary end point(s)
    Stage 1:
    a. Endoscopic response
    b. Clinical remission
    Stage 2:
    a. Endoscopic response
    b. Clinical remission
    Etapa 1:
    a. Respuesta endoscópica
    b. Remisión clínica
    Etapa 2:
    a. Respuesta endoscópica
    b. Remisión clínica
    E.5.1.1Timepoint(s) of evaluation of this end point
    Stage 1:
    a. at Week 12: Minimum of 50% decrease from Baseline in SES‑CD total score
    b. at Week 12: Average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND
    Average daily AP subscore of ≤ 1 as assessed on the CDAI AP item
    Stage 2:
    a. at Week 52
    b. at Week 52
    Etapa 1:
    a. en la semana 12: Reducción de un mínimo del 50 % respecto al período basal en la puntuación total de SES CD
    b. en la semana 12: Subpuntuación diaria media de LSF de ≤3 según la evaluación por el punto CDAI LSF, Y Subpuntuación diaria media de AP de ≤1 según la evaluación por el punto CDAI AP
    Etapa 2:
    a. en la semana 52
    b. en la semana 52
    E.5.2Secondary end point(s)
    Stage 1:
    a. Endoscopic response
    b. Clinical remission
    c. Endoscopic remission
    d. Clinical remission
    e. Endoscopic response and endoscopic remission
    f. Clinical remission
    Stage 2:
    a. Endoscopic response
    b. Clinical remission
    c. Endoscopic remission
    d. Clinical remission
    e. CS-free endoscopic remission
    f. CS-free clinical remission
    Etapa 1:
    a. Respuesta endoscópica
    b. Remisión clínica
    c. Respuesta endoscópica
    d. Remisión clínica
    e. Respuesta endoscópica and Remisión endoscópica
    f. Remisión clínica
    Stage 2:
    a. Respuesta endoscópica
    b. Remisión clínica
    c. Remisión endoscópica
    d. Remisión clínica
    e. Remisión endoscópica sin corticoesteroides
    f. Remisión clínica sin corticoesteroides
    E.5.2.1Timepoint(s) of evaluation of this end point
    Stage 1:
    a. at both Week 12 and Week 52
    b. at both Week 12 and Week 52
    c. at Week 52
    - SES-CD total score of 0-2 OR
    - SES-CD total score of ≤ 4 and at least 2‑point reduction from Baseline with no
    subscore > 1
    d. at Week 52
    e. at Week 12 and at Week 52
    f. at both Week 12 and Week 52
    Stage 2:
    a. at both Week 12 and Week 52.
    b. at both Week 12 and Week 52
    c. at Week 52
    d. at Week 52
    e. at Week 52
    f. at Week 52
    Etapa 1:
    a. en la semana 12 y en la semana 52
    b. en la semana 12 y en la semana 52
    c. en la semana 52
    - S Puntuación total de SES-CD de 0-2, O
    - Puntuación total de SES-CD de ≤4 y reducción de al menos 2 puntos respecto al período basal sin subpuntuación >1
    d. en la semana 52
    e. en la semana 12 y en la semana 52
    f. en la semana 12 y en la semana 52
    Etapa 2:
    a. en la semana 12 y en la semana 52
    b. en la semana 12 y en la semana 52
    c. en la semana 52
    d. en la semana 52
    e. en la semana 52
    f. en la semana 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy 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 No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Doble Simulación, Operativamente Eficiente
    Double Dummy, Operationally Seamless
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA180
    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
    Belgium
    Bulgaria
    Canada
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    Israel
    Italy
    Netherlands
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Sweden
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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 Ultimo Paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 150
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 150
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 600
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Adolescents
    Adolescentes
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 2000
    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)
    No interventions will be dispensed after the end of the study unless the participant enters the open-label brazikumab study (Study 3150-303-008).
    Ninguna intervención sera dispensada después del fin del studio a menos que el participante entre en el estudio abierto de brazikumab (Estudio 3150-303-008).
    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 Decision2019-12-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-06-01
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