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    Summary
    EudraCT Number:2018-001272-37
    Sponsor's Protocol Code Number:0173
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2018-08-09
    Trial results View 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 number2018-001272-37
    A.3Full title of the trial
    A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease
    Estudio de fase 2, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos, para evaluar la eficacia y seguridad de la terapia de inducción con 2 dosis de TD-1473 en pacientes con enfermedad de Crohn activa de intensidad moderada a severa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease
    Ensayo clínico para investigar la eficacia y la seguridad de TD-1473 en el tratamiento de la enfermedad de Crohn activa de intensidad moderada a severa
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and Safety of TD-1473 in Crohn’s Disease
    Eficacia y seguridad de TD-1473 en la enfermedad de Crohn
    A.4.1Sponsor's protocol code number0173
    A.5.4Other Identifiers
    Name:US INDNumber:139,354
    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 SponsorTheravance Biopharma Ireland Limited
    B.1.3.4CountryIreland
    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 supportTheravance Biopharma Ireland Limited
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTheravance Biopharma Ireland Limited
    B.5.2Functional name of contact pointClinical Operations - CC
    B.5.3 Address:
    B.5.3.1Street Address901 Gateway Boulevard
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post code94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number900811 335
    B.5.5Fax number+1650808 4181
    B.5.6E-mailIBDstudies@theravance.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 nameTD-1473
    D.3.2Product code TD-1473
    D.3.4Pharmaceutical form 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 INNNot assigned
    D.3.9.2Current sponsor codeTD-1473
    D.3.9.3Other descriptive nameTHRX-139060
    D.3.9.4EV Substance CodeSUB192730
    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 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 nameTD-1473
    D.3.2Product code TD-1473
    D.3.4Pharmaceutical form 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 INNNot Assigned
    D.3.9.2Current sponsor codeTD-1473
    D.3.9.3Other descriptive nameTHRX-139060
    D.3.9.4EV Substance CodeSUB192730
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated 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 activa de intensidad moderada a severa (EC)
    E.1.1.1Medical condition in easily understood language
    Crohn’s Disease (CD)
    Enfermedad de Crohn (EC)
    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 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 the study are as follows:
    • To assess the effect of TD-1473 compared to placebo in improving Crohn’s Disease Activity Index (CDAI) score at Week 12 in subjects with moderately-to-severely active CD
    • To assess the safety and tolerability of TD-1473
    Los objetivos principales del estudio son los siguientes:
    + Evaluar el efecto del TD-1473, comparado con placebo, en la consecución de una mejor puntuación en el Índice de actividad de la enfermedad de Crohn (CDAI) en la semana 12 en pacientes con EC activa de intensidad moderada a severa.
    + Evaluar la seguridad y tolerabilidad del TD-1473
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to assess the effects of TD-1473 given for 12 weeks compared to placebo as follows:
    • To induce clinical remission
    • To induce clinical response
    • To induce endoscopic response
    • To improve the Simplified Endoscopy Score for Crohn’s Disease (SES-CD)
    Los objetivos secundarios del estudio son evaluar los efectos del TD-1473 administrado durante 12 semanas, comparado con placebo, en los siguientes aspectos:
    + Inducción de la remisión clínica
    + Inducción de la respuesta clínica
    + Inducción de la respuesta endoscópica
    Obtención de una mejor puntuación en el Índice endoscópico simplificado de la enfermedad de Crohn (SES-CD)
    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 Genetic Test
    An optional genetic testing will be performed in all subjects who agree to participate and provide their additional specific consent. The genetic blood sample should be collected at the Day 1 visit
    Prueba genética opcional
    Se efectuará una prueba genética opcional in todos los sujetos que estén de acuerdo en participar y den su consentimiento específico adicional. La muestra de sangre para el análisis genético se debe tomar en la visita del día 1
    E.3Principal inclusion criteria
    Inclusion Criteria for Induction:
    1. Subject is willing and able to provide written, signed informed consent at Screening Part 1 prior to start of any study-related procedures
    2. Subject is a male or female at least 18 years of age at the time of Screening
    3. Subject has a history of CD with involvement of at least the ileum or any portion of the colon at a minimum, diagnosed by radiology, endoscopy, and/or histology at least 3 months prior to Screening by ileocolonoscopy and confirmed on histology. The report of a previous diagnostic exam (endoscopy, radiology, and/or pathology) must be reviewed by the investigator and included in the source documents.
    4. Subjects must have up-to-date colorectal cancer screening as per locally adopted guidelines (e.g., if subject has had ≥ 8 years of disease involving >30% of the colon, surveillance biopsies or chromoendoscopy should be performed if either is indicated as per locally adopted guidelines but has not been performed within the 12 months prior to Screening)
    5. Subject has CDAI score ≥ 220 and ≤ 450 (required in order to proceed to endoscopy during Screening Stage 2 visit)
    6. Subject has a SES-CD score of ≥ 6 (≥ 4 if isolated ileal disease) with ulceration (corresponding to a score of ≥1) in at least 1 of the 5 ileocolonic segments on the Ulcerated Surface subscore of the SES-CD, as assessed by central reading, during Screening
    7. Subject is corticosteroid-dependent or had intolerance or inadequate response to any of the following: aminosalicylates, corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate), or biologics (anti-TNF anti-IL- 12/IL-23 therapy, or integrin)
    8. If subject is currently receiving an oral corticosteroid, subject is eligible if:
    a. the subject has been on corticosteroid for a minimum of 4 weeks prior to Day 1 AND
    b. the dose is equivalent to or less than prednisone 25 mg/day or budesonide 9 mg/day AND
    c. the dose is stable for at least 2 weeks prior to Screening Stage 2 AND
    d. the subject is willing to continue on the same dose as warranted until Week 8
    9. If subject is currently receiving oral aminosalicylate (including, but not limited to sulfasalazine or mesalamine), the subject is eligible provided the subject has been on a stable dose for ≥ 3 weeks prior to Day 1 and is willing to stay on the same dose as warranted until Week 12
    Inclusion Criteria for ATE:
    1. Subject has completed Induction
    Criterios de inclusión para la inducción:
    1. Paciente dispuesto a y capaz de proporcionar un consentimiento informado firmado en la parte 1 de la selección antes del inicio de cualquier procedimiento relacionado con el estudio.
    2. Paciente hombre o mujer con una edad mínima de 18 años en el momento de la selección.
    3. Paciente con antecedentes de EC evidenciada mediante ileocolonoscopia y confirmada histológicamente, con afectación diagnosticada mediante radiología, endoscopia o histología de, como mínimo, el íleo o alguna porción del colon desde al menos 3 meses antes de la selección. El investigador deberá evaluar el informe de una exploración diagnóstica previa (endoscópica, radiológica o anatomopatológica) e incluirlo en los documentos fuente.
    4. Los pacientes deberán haber realizado las pruebas de detección sistemática de cáncer colorrectal de acuerdo con las directrices aprobadas a nivel local (por ej., si un paciente ha tenido la enfermedad durante ≥8 años con afectación de >30% del colon, deberían efectuarse biopsias o cromoendoscopias de vigilancia en caso de que cualquiera de las dos pruebas esté indicada en las directrices locales pero no se haya efectuado en los 12 meses previos a la selección).
    5. Paciente con una puntuación CDAI ≥220 y ≤450 (necesaria para proceder a realizar la endoscopia durante la visita de la etapa 2 de la selección).
    6. Paciente con una puntuación SES-CD ≥6 (≥4 en caso de enfermedad ileal aislada) con ulceración (correspondiente a una puntuación ≥1) en, como mínimo, uno de los cinco segmentos ileocolónicos en el subíndice de Superficie ulcerada del índice SES-CD, según interpretación centralizada, durante la selección.
    7. Paciente con dependencia de corticoesteroides o con intolerancia o respuesta inadecuada a cualquiera de los siguientes fármacos: aminosalicilatos, corticoesteroides, inmunomoduladores (azatioprina, 6-mercaptopurina o metotrexato) o agentes biológicos (anti-TNF, anti-IL-12/IL-23 o anti-integrinas).
    8. Si el paciente está recibiendo actualmente un corticoesteroide oral, será apto si:
    a. ha estado recibiendo el corticoesteroide durante un mínimo de 4 semanas antes del día 1 Y
    b. la dosis es equivalente o inferior a 25 mg/día de prednisona o 9 mg/día de budesonida Y
    c. la dosis se ha mantenido durante al menos 2 semanas antes de la etapa 2 de la selección Y
    d. el paciente está dispuesto a continuar con la misma dosis, según sea necesario, hasta la semana 8.
    9. Si el paciente recibe actualmente aminosalicilatos orales (incluidos, entre otros, sulfasalazina o mesalamina) será apto siempre y cuando haya estado recibiendo una dosis estable durante ≥3 semanas antes del día 1 y esté dispuesto a seguir con la misma dosis, según sea necesario, hasta la semana 12.
    Criterios de inclusión para la fase de PTA:
    1. El paciente ha completado la fase de inducción.
    E.4Principal exclusion criteria
    Exclusion Criteria Pertinent to GI:
    1. Subject with a confirmed or suspected diagnosis or history of primary sclerosing cholangitis (PSC)
    2. Subject has had extensive colonic resection (i.e., more than half of colon), subtotal or total colectomy, intestinal resection within 6 months of Screening, > 2 small bowel resections or carries a diagnosis of short bowel syndrome or currently has an ostomy
    3. Subject has a history of colonic mucosal dysplasia. Subjects will not be excluded from the study because of a pathology finding of indefinite dysplasia with reactive atypia or because of spontaneous (non-colitis-associated) adenomas that have been completely resected
    Exclusion Criteria Pertinent to Medications:
    1. Medications of exclusion (Refer to Protocol Section 6.4.29 for prohibited medications) below must be discontinued within the timeframe specified (if applicable)
    • azathioprine, 6-mercaptopurine, or methotrexate taken within the 14 days prior to Day 1
    • anti-TNFs (e.g., adalimumab, infliximab, golimumab, etanercept, certolizumab, or biosimilars) taken within the 60 days or 5 half-lives, whichever is shorter, prior to Day 1
    • intravenous corticosteroids within the 14 days prior to Day 1
    • rectal mesalamine or corticosteroid (i.e., enemas or suppositories) taken within the 14 days prior to Day 1
    • prior exposure to vedolizumab, ustekinumab, mycophenolic acid, tacrolimus, sirolimus, or cyclosporine taken within 60 days prior to Day 1
    • Any prior exposure to natalizumab, rituximab, efalizumab, fingolimod, cyclophosphamide, or thalidomide
    • NSAIDs taken on a regular (more than 3 times per week, on average) basis (regular use of aspirin ≤ 325 mg per day for cardiovascular protection is allowed).
    • anakinra or any other immune-modifying biologic agent taken within 90 days, or 5 half-lives, whichever is shorter, prior to Day 1
    2. Any prior exposure to an approved JAK inhibitor or potential exposure to an investigational JAK inhibitor
    3. Subject has participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Screening or 5x the half-life of the investigational drug, whichever is longer, or is currently participating in another trial of an investigational drug (or medical device)
    4. Subject has failed ≥ 3 biologic agents of 3 different mechanisms of action (i.e., anti-TNF, anti-integrin, and anti-IL12/23)
    Exclusion Criteria Pertinent to Infections:
    1. Subject is positive for:
    a. hepatitis B virus (HBV) surface antigen
    b. hepatitis B virus core antibody (unless subject has positive hepatitis B surface antibody and undetectable serum hepatitis B DNA)
    c. hepatitis C virus (HCV) antibody unless: a) there is evidence of undetectable viral load measured twice six months apart after completion of treatment regimen and b) viral load during Screening is undetectable
    d. hepatitis E antibody
    e. human immunodeficiency virus (HIV) antibody
    2. The subject has or may have untreated active or latent TB as evidenced by any of the following:
    a. Two indeterminate or one positive QuantiFERON®-TB Gold result within 90 days prior to screening or during the Screening Period, without having completed an adequate treatment for latent or active TB before Screening OR
    b. Chest X-ray within 90 days prior to Screening in which active or latent pulmonary TB cannot be excluded.
    A subject who has a history of latent or active tuberculosis (TB) may be eligible for the study if criteria outlined in Protocol Section 6.4.15 are met.
    3. Subject has:
    a. an active bacterial, parasitic, fungal, mycobacterial (including atypical infection), or viral infection, except for local skin or nail bed infection, within 30 days prior to Day 1
    b. any infection requiring hospitalization or intravenous antibiotics within 30 days prior to Screening
    c. any infection requiring oral antimicrobial treatment within 2 weeks prior to Screening
    d. a history of more than one episode of herpes zoster or one or more episodes of disseminated or complicated herpes zoster (complicated: multi-dermatomal, ophthalmic, or CNS involvement or post-herpetic neuralgia) or disseminated herpes simplex
    4. Subject has C. difficile or other gastrointestinal infections (e.g., Salmonella, Shigella, Yersinia, Campylobacter, E. Coli, etc.) on stool testing or cytomegalovirus [CMV] colitis suspected on endoscopic appearance during Screening. Subject may be treated, re-tested, and re- screened.
    Relativos al tracto GI:
    1. Diagnóstico confirmado o de sospecha o antecedentes de colangitis esclerosante primaria (CEP)
    2. Resección amplia del colon (más de la mitad del colon), colectomía subtotal o total, o resección intestinal en los 6 meses anteriores a la selección, con >2 resecciones del intestino delgado o diagnóstico de síndrome del intestino corto, o que actualmente tenga una ostomía
    3. Antecedentes de displasia de la mucosa del colon. No se excluirá a pacientes por un hallazgo anatomopatológico de displasia indefinida con atipia reactiva o por la presencia de adenomas espontáneos (no asociados a colitis) que se hayan extirpado completamente
    Relativos a los medicamentos:
    1. Los medicamentos siguientes que conllevan la exclusión del paciente (véase la Sección 6.4.29), deben suspenderse en los plazos especificados (si procede):
    + azatioprina, 6-mercaptopurina o metotrexato, en los 14 días previos al día 1
    + anti-TNF (por ej., adalimumab, infliximab, golimumab, etanercept, certolizumab o biosimilares) en los 60 días, o el periodo equivalente a 5 semividas, lo que suponga el menor tiempo, antes del día 1
    + corticoesteroides intravenosos en los 14 días previos al día 1;
    + mesalamina o corticoesteroides por vía rectal (es decir, enemas o supositorios) en los 14 días previos al día 1
    + exposición previa a vedolizumab, ustekinumab, ácido micofenólico, tacrólimus, sirolimus o ciclosporina en los 60 días previos al día 1
    + cualquier exposición previa a natalizumab, rituximab, efalizumab, fingolimod, ciclofosfamida o talidomida
    + AINE tomados habitualmente (más de 3 veces por semana, en promedio; se permite la toma habitual de ≤325 mg al día de ácido acetilsalicílico para profilaxis cardiovascular)
    + anakinra o cualquier otro agente biológico modificador de la respuesta inmunitaria, en los 90 días, o el periodo equivalente a 5 semividas, lo que suponga el menor tiempo, previos al día 1
    2. Exposición previa a un inhibidor JAK aprobado o posible exposición a un inhibidor JAK en investigación
    3. Paciente que haya participado en otro ensayo clínico con un fármaco (o producto sanitario) en investigación en los 30 días previos a la selección o el periodo equivalente a las 5 semividas del fármaco en investigación, lo que suponga el mayor tiempo, o que esté participando en otro ensayo con un medicamento (o producto sanitario) en investigación
    4. Paciente sin respuesta a ≥3 agentes biológicos con 3 mecanismos de acción distintos (anti-TNF, anti-integrinas y anti-IL12/23)
    Relativos a infecciones:
    1. El paciente presenta resultados positivos para:
    a. antígeno de superficie del virus de la hepatitis B (VHB)
    b. anticuerpos contra el antígeno central del VHB (excepto si el paciente tiene resultados positivos para los anticuerpos contra el antígeno de superficie del VHB y ADN del VHB indetectable en suero)
    c. anticuerpos contra el virus de la hepatitis C (VHC) excepto si: a) se han obtenido pruebas de una carga viral indetectable en mediciones realizadas en dos ocasiones con un intervalo de seis meses entre ellas, después de la finalización de la pauta de tratamiento y b) la carga viral durante la selección es indetectable
    d. anticuerpos contra el virus de la hepatitis E
    e. anticuerpos contra el virus de la inmunodeficiencia humana (VIH)
    2. El paciente presenta o podría presentar una tuberculosis (TB) activa o latente no tratada, que se demuestre por cualquiera de las pruebas siguientes:
    a. Dos resultados de QuantiFERON®-TB Gold indeterminados o uno positivo en los 90 días previos a la selección o durante el periodo de selección, sin haber completado un tratamiento adecuado para la TB latente o activa antes de la selección O
    b. Radiografía de tórax en los 90 días previos a la selección con la cual no se puede descartar una TB activa o latente
    Un paciente con antecedentes de TB latente o activa puede ser apto para el estudio si se cumplen los criterios descritos en la Sección 6.4.15.
    3. Paciente con:
    a. infección activa bacteriana, parasitaria, micótica, micobacteriana (incluidas las infecciones atípicas) o vírica, excepto infección cutánea local o del lecho ungueal, en los 30 días previos al día 1
    b. infección que requiera hospitalización o antibióticos por vía intravenosa en los 30 días previos a la selección
    c. infección que requiera tratamiento antimicrobiano oral en las 2 semanas previas a la selección
    d. antecedentes de más de un episodio de herpes zóster o de uno o más episodios de herpes zóster diseminado o complicado (multidermatómico, oftálmico o afectación del SNC o neuralgia postherpética) o herpes simple diseminado
    4. infección por C. difficile u otras infecciones gastrointestinales (por ej., salmonella, shigela, yersinia, campylobacter, E. coli, etc.) en análisis de heces o sospecha de colitis por citomegalovirus [CMV] según lo observado en la endoscopia durante la selección. Se puede tratar al paciente, repetir los análisis y volver a someterse a proceso de selección
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is:
    • CDAI score change from baseline at Week 12
    El criterio de valoración principal es:
    + Variación respecto a la evaluación basal en la puntuación CDAI en la semana 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    • CDAI clinical response (defined as reduction from baseline of ≥ 100 points or CDAI < 150) at Week 12
    • CDAI clinical remission (defined as CDAI < 150) at Week 12
    • SES-CD change from baseline at Week 12
    • Endoscopic response (SES-CD reduction of ≥ 50% from baseline or endoscopic remission) at Week 12
    • SFAP clinical remission defined as abdominal pain score ≤ 1 (on a scale of 0-3), stool frequency ≤ 2.8, and both not worse than baseline at Week 12
    Study Safety Endpoints:
    • Changes from baseline in vital signs, ECGs, and clinical laboratory results
    • Incidence and severity of AEs
    Los criterios de valoración secundarios son:
    + Respuesta clínica según la puntuación CDAI (definida como una reducción ≥100 puntos respecto a la evaluación basal o una puntuación CDAI <150) en la semana 12
    + Remisión clínica según la puntuación CDAI (definida como una puntuación en la CDAI <150) en la semana 12
    + Cambio en la puntuación SES-CD en la semana 12, respecto a la evaluación basal
    + Respuesta endoscópica (reducción en la SES-CD ≥50% respecto a la evaluación basal o remisión endoscópica) en la semana 12
    + Remisión clínica en la FDDA, definida como una puntuación del dolor abdominal ≤1 (en una escala de 0 a 3), una frecuencia de deposiciones ≤2,8 y ambos parámetros con un resultado en la semana 12 que no sea peor al de la evaluación basal.
    Criterios de valoración de la seguridad del estudio:
    + Variaciones, respecto a la evaluación basal, en las constantes vitales, los ECG y los resultados analíticos
    + Incidencia e intensidad de los AE
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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
    Fase combinada de inducción y prolongación del tratamiento activo (PTA)
    Combined Induction and Active Treatment Extension (ATE) phase
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    Bulgaria
    Croatia
    France
    Georgia
    Germany
    Greece
    Hungary
    Israel
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    South Africa
    Spain
    Ukraine
    United Kingdom
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 160
    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)
    None
    Ninguno
    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 Decision2018-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-27
    P. End of Trial
    P.End of Trial StatusRestarted
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