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    Summary
    EudraCT Number:2016-001367-36
    Sponsor's Protocol Code Number:GS-US-419-3895
    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:2017-02-01
    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 number2016-001367-36
    A.3Full title of the trial
    Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease
    Estudios combinados de fase III, aleatorizados, doble ciego y controlados con placebo, para evaluar la eficacia y la seguridad de filgotinib en la inducción y el mantenimiento de la remisión en pacientes con enfermedad de Crohn de actividad moderada a intensa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease
    Estudio para evaluar un nuevo tratamiento en pacientes con enfermedad de Crohn de actividad moderada a intensa
    A.4.1Sponsor's protocol code numberGS-US-419-3895
    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 SponsorGilead Sciences, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34913789830
    B.5.5Fax number+441223897284
    B.5.6E-mailclinical.trials@gilead.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 nameFilgotinib
    D.3.2Product code GS-6034
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFILGOTINIB
    D.3.9.3Other descriptive nameFilgotinib
    D.3.9.4EV Substance CodeSUB182273
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFilgotinib
    D.3.2Product code GS-6034
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFILGOTINIB
    D.3.9.3Other descriptive nameFilgotinib
    D.3.9.4EV Substance CodeSUB182273
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral 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 (CD)
    Enfermedad de Crohn de actividad moderada a intensa (EC)
    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 19.1
    E.1.2Level LLT
    E.1.2Classification code 10013099
    E.1.2Term Disease Crohns
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of Cohort A Induction Study are:
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical remission by Patient Reported Outcomes (PRO2) at Week 10
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing endoscopic response at Week 10

    The primary objectives of Cohort B Induction Study are:
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical remission by PRO2 at Week 10
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing endoscopic response at Week 10

    The primary objectives of the Maintenance Study are:
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical remission by PRO2 at Week 58
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing endoscopic response at Week 58
    Los objetivos principales del estudio de inducción en la cohorte A son:
    •Evaluar la eficacia de filgotinib, en comparación con placebo,en cuanto a remisión clínica determinada mediante los resultados notificados por el paciente de 2 ítems(RNP2)en semana 10.
    •Evaluar la eficacia de filgotinib, en comparación con placebo, en cuanto a respuesta endoscópica en la semana 10
    Los objetivos principales del estudio de inducción en la cohorte B son:
    •Evaluar la eficacia de filgotinib,en comparación con placebo,en cuanto a remisión clínica determinada mediante los RNP2 en semana 10
    •Evaluar la eficacia de filgotinib,en comparación con placebo,en cuanto a respuesta endoscópica en semana 10.
    Los objetivos principales del estudio de mantenimiento son:
    •Evaluar la eficacia de filgotinib,en comparación con placebo,en cuanto a remisión clínica determinada mediante los RNP2 en semana 58
    •Evaluar la eficacia de filgotinib,en comparación con placebo,en cuanto a respuesta endoscópica en semana 58
    E.2.2Secondary objectives of the trial
    Key secondary objectives of both Cohort A Induction Study & Cohort B Induction Study are:
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical remission by Crohn’s Disease Activity Index (CDAI) at Week 10
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing both clinical remission by PRO2 score & endoscopic response at Week 10

    Key secondary objectives of the Maintenance Study are:
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical remission by CDAI at Week 58
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing sustained clinical remission by PRO2 at Weeks 10 & 58
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing both clinical remission by PRO2 & endoscopic response at Week 58
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing 6-month corticosteroid-free remission by PRO2 at Week 58
    Objetivos secundarios fundamentales de los estudios de inducción en cohortes A y B son evaluar eficacia de filgotinib,en comparación con placebo,en cuanto a remisión clínica determinada mediante:
    -Indice de actividad de la enfermedad de Crohn(CDAI,Crohn’s Disease Activity Index)en semana 10
    -RNP2 y respuesta endoscópica en semana 10
    Objetivos secundarios fundamentales del estudio de mantenimiento son:
    -Evaluar eficacia de filgotinib,en comparación con placebo,en cuanto a remisión clínica determinada mediante CDAI en semana 58
    -Evaluar eficacia de filgotinib en comparación con placebo,en cuanto al mantenimiento de remisión clínica determinada mediante RNP2 en semanas 10 y 58
    -Evaluar eficacia de filgotinib en comparación con placebo,en cuanto a remisión clínica determinada mediante RNP2 y respuesta endoscópica en semana 58
    -Evaluar eficacia de filgotinib en comparación con placebo,en cuanto a remisión sin corticoesteroides durante 6 meses determinada mediante RNP2 en semana 58
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic (PK) Substudy
    An optional PK substudy will be performed in a subset of subjects (approximately 30 subjects each in Cohort A and Cohort B) who provide a separate informed consent. In the PK substudy, the daily dose of study drug should be administered under supervision in the clinic (between Week 2 and Week 10 inclusive), and additional PK samples should be collected predose and at 0.5, 1, 2, 3, 4, and 6 hours post dose.

    Genomic Substudy
    An optional genomic substudy will be performed in all subjects who agree to participate and provide their additional specific consent. The genomic sample should be collected at the Day 1 visit, but may be collected at any time during the study.
    Subestudio de farmacocinética (FC)
    Se realizará un subestudio FC opcional en un subconjunto de pacientes (aproximadamente 30 pacientes en la cohorte A y 30 en la B) que proporcionen un consentimiento informado aparte. En el subestudio FC, la dosis diaria del fármaco del estudio se debe administrar bajo supervisión en el centro (en una visita entre las semanas 2 y 10, ambas inclusive) y se deben obtener muestras para FC antes de la dosis y 0,5, 1, 2, 3, 4 y 6 horas después de la dosis

    Subestudio de genómica
    Se llevará a cabo un subestudio de genómica opcional en todos los pacientes que accedan a participar y den su consentimiento específico adicional. La muestra para genómica se debería recoger en la visita del día 1, pero podrá hacerse en cualquier momento durante el estudio.
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for participation in either the Cohort A or B Induction Study.
    • Must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures
    • Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit
    • Females of childbearing potential must have a negative pregnancy test at screening and baseline
    • Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
    • Documented diagnosis of CD with a minimum disease duration of 6 months with involvement of the ileum and/or colon at a minimum
    • Moderately or severely active CD
    • Meet one of the protocol specified tuberculosis (TB) screening criteria
    • May be receiving the following drugs (subjects on these therapies must be willing to remain on stable doses for the times noted in the protocol)
    - Oral 5-aminosalicylate (5-ASA) compounds
    - Azathioprine or 6-mercaptopurine (6-MP) or methotrexate (MTX)
    - Oral corticosteroid therapy
    - Antibiotics for the treatment of CD
    • Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose

    Subjects must meet all of the additional inclusion criteria to be eligible for participation in Cohort A Induction Study.
    • Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least one of the following agents (depending on current country treatment recommendations/guidelines):
    - Corticosteroids
    - Immunomodulators

    Subjects must meet all of the additional inclusion criteria to be eligible for participation in Cohort B induction study.
    • Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least one of the following agents:
    - TNFα Antagonists
    - Vedolizumab
    • Must not have used any TNFα antagonist or vedolizumab ≤ 8 weeks prior to screening or any other biologic agent ≤ 8 weeks prior to screening or within 5 times the half-life of the biologic agent prior to screening, whichever is longer

    Subjects must meet all of the following inclusion criteria to be eligible for participation in the Maintenance Study.
    • Completion of Cohort A or B induction study with either clinical remission by PRO2 or endoscopic response at Week 10
    • Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose
    • May be on oral corticosteroid therapy (prednisone prescribed at a stable dose ≤ 30 mg/day or budesonide at a dose of ≤ 9 mg/day); dose must remain stable to Week 14
    Los pacientes deben cumplir todos los criterios de inclusión siguientes a fin de ser aptos para participar en las cohortes A o B del estudio de inducción.
    • Deben poder comprender y firmar un formulario de consentimiento informado por escrito, que debe obtenerse antes de iniciar los procedimientos del estudio.
    • Pueden ser hombres o mujeres no embarazadas ni en período de lactancia, con edad comprendida entre los 18 y los 75 años en la fecha de la visita de selección.
    • Las pacientes en edad fértil deben obtener un resultado negativo en una prueba de embarazo en la visita de selección e inicio.
    • Los pacientes de sexo masculino y las de sexo femenino con capacidad de concebir que mantengan relaciones sexuales heterosexuales deben aceptar el uso de los métodos anticonceptivos especificados en el protocolo.
    • Diagnóstico documentado de enfermedad de Crohn (EC) con una duración mínima de 6 meses con afectación mínima del íleon o el colon.
    • EC con actividad moderada o intensa.
    • Cumplir uno de los criterios de selección de tuberculosis (TB) especificado en el protocolo.
    • Pueden estar recibiendo los siguientes fármacos (pero deben estar dispuestos a seguir recibiendo dosis estables durante los momentos señalados en el protocolo):
    - Compuestos de 5-aminosalicilato (5-AAS) por vía oral.
    - Azatioprina o 6-mercaptopurina (6-MP) o metotrexato (MTX).
    - Tratamiento con corticoesteroides por vía oral.
    - Antibióticos para el tratamiento de la EC.
    • Disposición para evitar recibir vacunas elaboradas con microorganismos vivos o atenuados durante el estudio y durante las 12 semanas siguientes a la última dosis.

    Los pacientes deben cumplir todos los criterios de inclusión adicionales a fin de ser aptos para participar en la cohorte A del estudio de inducción.
    • Respuesta clínica insuficiente, pérdida de la respuesta o intolerancia demostradas con anterioridad a al menos uno de los siguientes fármacos (según las recomendaciones/directrices de tratamiento en vigor de cada país):
    - Corticoesteroides.
    - Inmunomoduladores.

    Los pacientes deben cumplir todos los criterios de inclusión adicionales a fin de ser aptos para participar en la cohorte B del estudio de inducción.
    • Respuesta clínica insuficiente, pérdida de la respuesta o intolerancia demostradas con anterioridad con al menos uno de los siguientes fármacos:
    - Antagonistas del TNFα.
    - Vedolizumab.
    • No haber utilizado ningún antagonista del TNFα ni vedolizumab en un plazo de ≤8 semanas antes de la selección, ni ningún otro fármaco biológico en un plazo de ≤8 semanas antes de la selección o de 5 veces la semivida del fármaco biológico antes de la selección, lo que suponga más tiempo.

    Los pacientes deben cumplir todos los criterios de inclusión siguientes a fin de ser aptos para participar en el estudio de mantenimiento.
    • Finalización del estudio de inducción en las cohortes A o B, con remisión clínica determinada mediante los RNP2 o con respuesta endoscópica en la semana 10.
    • Disposición para evitar recibir vacunas elaboradas con microorganismos vivos o atenuados durante el estudio y durante las 12 semanas siguientes a la última dosis.
    • Pueden utilizar tratamiento con corticoesteroides por vía oral (receta de prednisona a una dosis estable de ≤30 mg/día o budesonida a una dosis de ≤9 mg/día); la dosis debe permanecer estable hasta la semana 14.
    E.4Principal exclusion criteria
    Subjects who meet any of the following exclusion criteria are not to be enrolled in either the Cohort A or B induction study
    • Pregnant or lactating females
    • Males and females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods
    • Females who may wish to become pregnant and/or plan to undergo egg donation or egg harvesting for the purpose of current or future fertilization during the course of the study and up to 35 days after the last dose of the study drug
    • Male subjects unwilling to refrain from sperm donation during the study and for at least 90 days after the last dose of study drug
    • Known hypersensitivity to filgotinib
    • Currently have complications of CD
    • Have any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to Day 1 and are not anticipated to require surgery
    • History of major surgery or trauma within 30 days prior to screening
    • Presence of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
    • History of total colectomy, hemi-colectomy, presence of ileostomy or colostomy, or likely requirement for surgery during the study
    • Dependence on parenteral nutrition
    • History or evidence of incompletely resected colonic mucosal dysplasia
    • Stool sample positive for Clostridium difficile (C. diff) toxin, Escherichia coli (E. coli), Salmonella species (spp), Shigella spp, Campylobacter spp, or Yersinia spp
    • Stool sample positive for ova and parasites test (O&P) unless approved by the medical monitor
    • Active clinically significant infection or any infection requiring hospitalization or treatment with intravenous anti-infectives within 30 days of screening (or 8 weeks of Day 1); or any infection requiring oral anti-infective therapy within 2 weeks of screening (or 6 weeks of Day 1)
    • Infection with HIV, hepatitis B, or hepatitis C
    • Presence of Child-Pugh Class C hepatic impairment
    • Active TB or history of latent TB that has not been treated
    • History of malignancy within the last 5 years except for subjects who have been treated or resected for non-melanoma skin cancer or cervical carcinoma in situ
    • History of lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorder, or multiple myeloma
    • History of treatment with lymphocyte-depleting therapies, including but not limited to alemtuzumab, cyclophosphamide, total lymphoid radiation, and rituximab
    • History of leukocytapheresis ≤ 6 months prior to screening
    • Use of any prohibited concomitant medications as described in the protocol
    • Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease) or psychiatric problem (including, but not limited to alcohol or drug abuse) that, in the opinion of the Investigator, would make the subject unsuitable for the study or would prevent compliance with the study protocol
    • Administration of a live or attenuated vaccine within 30 days of randomization
    • History of opportunistic infection or immunodeficiency syndrome
    • Currently on any chronic systemic (oral or intravenous) anti-infective therapy for chronic infection (such as pneumocystis (PCP), cytomegalovirus (CMV), herpes zoster, atypical mycobacteria)
    • History of disseminated Staphylococcus aureus
    • History of symptomatic herpes zoster or herpes simplex within 12 weeks of screening, or any history of disseminated herpes simplex, herpes zoster, ophthalmic zoster, or central nervous system zoster

    Subjects who meet any of the following exclusion criteria are not to be enrolled in Cohort A induction study.
    • Prior or current use of TNFα antagonist, including (but not limited to) infliximab, adalimumab, golimumab, certolizumab, or biosimilar agent
    • Prior or current use of vedolizumab

    Subjects who meet the following exclusion criterion are not to be enrolled in Cohort B induction study.
    • Have used any TNFα antagonist or vedolizumab ≤ 8 weeks prior to screening or any other biologic agent ≤ 8 weeks prior to screening or within 5 times the half-life of the biologic agent prior to screening, whichever is longer

    Subjects who meet any of the following exclusion criteria are not to be enrolled in the maintenance study.
    • Males and females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods
    • Females who may wish to become pregnant and/or plan to undergo egg donation or egg harvesting for the purpose of current or future fertilization during the course of the study and up to 35 days after the last dose of the study drug
    • Male subjects unwilling to refrain from sperm donation during the study and for at least 90 days after the last dose of study drug
    • Use of any prohibited concomitant medications as described in the protocol
    cohortes A ni B: Mujeres embarazadas o en período de lactancia;Hombres y mujeres con capacidad de procrear que no estén dispuestos a ceñirse a los métodos anticonceptivos especificados en el protocolo;Mujeres que deseen quedarse embarazadas o tengan previsto someterse a una donación o extracción de óvulos con el objeto de llevar a cabo su fecundación, en el momento actual o en el futuro, durante el transcurso del estudio y hasta durante 35 días después de la última dosis del fármaco del estudio;Hombres que no estén dispuestos a abstenerse de donar semen durante el estudio y al menos 90 días después de la última dosis del fármaco del estudio;Hipersensibilidad conocida al filgotinib;Presentar complicaciones de la EC en la actualidad;Presentar algún absceso actual o anterior, a menos que se les haya drenado y hayan recibido tratamiento al menos 6 semanas antes del día 1 y que no se prevea que necesiten intervención quirúrgica;Antecedentes de cirugía mayor o traumatismo en los 30 días anteriores a la selección;Presencia de colitis ulcerosa (CU), indeterminada, isquémica o fulminante, o megacolon tóxico;Antecedentes de colectomía total, hemicolectomía, presencia de ileostomía o colostomía, o probable necesidad de intervención quirúrgica durante el estudio.• Dependencia de nutrición parenteral;Antecedentes o pruebas de displasia de la mucosa del colon con resección incompleta;Resultados positivos en el análisis de heces para toxina de Clostridium difficile (C. diff), Escherichia coli (E. coli) o de las especies Salmonella, Shigella, Campylobacter o Yersinia;Resultados positivos de las muestras de heces en la prueba de huevos y parásitos, a menos que lo haya aprobado el supervisor médico;Infección activa clínicamente significativa o cualquier infección que exija hospitalización o tratamiento con agentes antiinfecciosos por vía intravenosa en los 30 días antes de la selección (u 8 semanas antes del día 1); o cualquier infección que exija tratamiento antiinfeccioso por vía oral en las 2 semanas antes de la selección (o 6 semanas antes del día 1); Infección por el VIH, la hepatitis B o la hepatitis C;Presencia de trastorno hepático de clase C por Child-Pugh;TB activa o antecedentes de TB latente que no haya recibido tratamiento;Antecedentes de neoplasia maligna en los últimos 5 años, a excepción de los pacientes que hayan recibido tratamiento por cáncer cutáneo no melanómico o carcinoma cervicouterino in situ, o a los que se les haya extirpado;Antecedentes de trastorno linfoproliferativo, linfoma, leucemia, trastorno mieloproliferativo o mieloma múltiple;Antecedentes de tratamiento con depletores de linfocitos, incluyendo, entre otros, alemtuzumab, ciclofosfamida, radioterapia linfoidea total y rituximab;Antecedentes de leucocitaféresis ≤6 meses antes de la selección;Uso de algún medicamento concomitante prohibido según lo descrito en el protocolo;Cualquier afección crónica médica (incluyendo, entre otras, neumopatía o cardiopatía) o psiquiátrica (incluyendo, entre otras, alcoholismo o drogadicción) que, en opinión del investigador, haría que el paciente no fuera apto para el estudio o impediría el cumplimiento de su protocolo;Administración de una vacuna con microorganismos vivos o atenuados en los 30 días anteriores a la aleatorización;Antecedentes de infección oportunista o síndrome de inmunodeficiencia;Tratamiento antiinfeccioso sistémico crónico (por vía oral o intravenosa) por infección crónica (como Pneumocystis, citomegalovirus, herpes zóster, micobacterias atípicas);Antecedentes de Staphylococcus aureus diseminado;Antecedentes de herpes zóster o herpes simple sintomáticos en las 12 semanas anteriores a la selección, o cualquier antecedente de herpes simple diseminado, herpes zóster, zóster oftálmico o zóster del sistema nervioso central.cohorte A:Uso anterior o actual de antagonistas del TNFα incluyendo (entre otros), infliximab, adalimumab, golimumab, certolizumab o fármacos biosimilares; Uso actual o anterior de vedolizumab.cohorte B:Haber utilizado algún antagonista del TNFα o vedolizumab en las ≤8 semanas antes de la selección, o algún otro fármaco biológico en un plazo de ≤8 semanas antes de la selección o de 5 veces la semivida del fármaco biológico antes de la selección, lo que suponga más tiempo.Estudio de mantenimiento: Hombres y mujeres con capacidad de procrear que no estén dispuestos a ceñirse a los métodos anticonceptivos especificados en el protocolo;Mujeres que deseen quedarse embarazadas o tengan previsto someterse a una donación o extracción de óvulos con el objeto de llevar a cabo su fecundación, en el momento actual o en el futuro, durante el transcurso del estudio y hasta durante 35 días después de la última dosis del fármaco del estudio;Hombres que no estén dispuestos a abstenerse de donar semen durante el estudio y al menos 90 días después de la última dosis del fármaco del estudio;Uso de algún medicamento concomitante prohibido según lo descrito en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Cohort A Induction Study
    • The proportion of subjects achieving clinical remission by PRO2 at Week 10
    • The proportion of subjects achieving endoscopic response at Week 10

    Cohort B Induction Study
    • The proportion of subjects achieving clinical remission by PRO2 at Week 10
    • The proportion of subjects achieving endoscopic response at Week 10

    Maintenance Study
    • The proportion of subjects achieving clinical remission by PRO2 at Week 58
    • The proportion of subjects achieving endoscopic response at Week 58
    Cohorte A del estudio de inducción
    • La proporción de pacientes que logra la remisión clínica determinada por los RNP2 en la semana 10.
    • La proporción de pacientes que alcanza la respuesta endoscópica en la semana 10.

    Cohorte B del estudio de inducción
    • La proporción de pacientes que logra la remisión clínica determinada por los RNP2 en la semana 10.
    • La proporción de pacientes que alcanza la respuesta endoscópica en la semana 10.

    Estudio de mantenimiento.
    • La proporción de pacientes que logra la remisión clínica determinada por los RNP2 en la semana 58.
    • La proporción de pacientes que alcanza la respuesta endoscópica en la semana 58.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 10 and Week 58
    Semana 10 y semana 58
    E.5.2Secondary end point(s)
    Cohort A Induction Study
    The key secondary endpoints are:
    • The proportion of subjects achieving clinical remission by CDAI at Week 10
    • The proportion of subjects achieving both clinical remission by PRO2 and endoscopic response (combined into a single endpoint on a patient level) at Week 10

    Cohort B Induction Study
    The key secondary endpoints are:
    • The proportion of subjects achieving clinical remission by CDAI at Week 10
    • The proportion of subjects achieving both clinical remission by PRO2 and endoscopic response (combined into a single endpoint on a patient level) at Week 10

    Maintenance Study
    The key secondary endpoints are:
    • The proportion of subjects achieving clinical remission by CDAI at Week 58
    • The proportion of subjects achieving sustained clinical remission by PRO2 at Weeks 10 and 58
    • The proportion of subjects achieving both clinical remission by PRO2 and endoscopic response (combined into a single endpoint on a patient level) at Week 58
    • The proportion of subjects achieving 6 month corticosteroid-free remission by PRO2 at Week 58
    Cohorte A del estudio de inducción
    Los criterios de valoración secundarios clave son:
    • La proporción de pacientes que logra la remisión clínica determinada por el índice de actividad de enfermedad de Crohn (Crohn’s disease activity index, CDAI) en la semana 10.
    • La proporción de pacientes que logra tanto la remisión clínica determinada por los RNP2 como la respuesta endoscópica (combinadas en un único criterio de valoración a nivel del paciente) en la semana 10.

    Cohorte B del estudio de inducción
    Los criterios de valoración secundarios clave son:
    • La proporción de pacientes que logra la remisión clínica determinada por el CDAI en la semana 10.
    • La proporción de pacientes que logra tanto la remisión clínica determinada por los RNP2 como la respuesta endoscópica (combinadas en un único criterio de valoración a nivel del paciente) en la semana 10.

    Estudio de mantenimiento
    Los criterios de valoración secundarios clave son:
    • La proporción de pacientes que logra la remisión clínica determinada por el CDAI en la semana 58.
    • La proporción de pacientes que alcanza la remisión clínica mantenida, determinada mediante los RNP2, en las semanas 10 y 58.
    • La proporción de pacientes que logra tanto la remisión clínica determinada por los RNP2 como la respuesta endoscópica (combinadas en un único criterio de valoración a nivel del paciente) en la semana 58.
    • La proporción de pacientes que logra la remisión sin corticoesteroides durante 6 meses determinada mediante los RNP2 en la semana 58.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 10 and Week 58
    Semana 10 y semana 58
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Estudio de diseño combinado, con fase de inducción y mantenimiento
    Combined induction and maintenance phase study design
    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 trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned16
    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
    Argentina
    Australia
    Austria
    Belarus
    Belgium
    Brazil
    Bulgaria
    Canada
    Croatia
    Czech Republic
    France
    Georgia
    Germany
    Greece
    Hong Kong
    Hungary
    Iceland
    India
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    Netherlands
    New Zealand
    Norway
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Singapore
    Slovakia
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    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
    End of Study is defined as when the last subject has completed 58 weeks of treatment plus 30 days follow-up.
    El fin de estudio se define como cuando el último sujeto ha completado 58 semanas de tratamiento, más 30 días de seguimiento.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days26
    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: 1214
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 106
    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 state29
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 510
    F.4.2.2In the whole clinical trial 1320
    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)
    All subjects completing all study related procedures, including endoscopy at Week 58, will be offered an opportunity to participate in the LTE study. For those subjects who do not participate in the LTE study, after the subject has completed their study participation, the long-term care of the participant will remain the responsibility of their primary treating physicians.
    Se ofrecerá a todos los pacientes que completen todos los procedimientos relacionados con el estudio, incluyendo la endoscopia en la semana 58, una oportunidad para participar en el estudio ELP. En el caso de los pacientes que no participen en el estudio ELP, después de finalizar su participación en el estudio, la responsabilidad de la atención a largo plazo del participante continuará recayendo en sus médicos primarios tratantes.
    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 Decision2017-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-25
    P. End of Trial
    P.End of Trial StatusCompleted
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