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    Summary
    EudraCT Number:2017-001976-48
    Sponsor's Protocol Code Number:IM011023
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-07-17
    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 number2017-001976-48
    A.3Full title of the trial
    A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease
    Estudio de fase II aleatorizado, doble ciego y controlado con placebo, para evaluar la seguridad y la eficacia de BMS-986165 en pacientes con enfermedad de Crohn de moderada a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease
    Estudio de fase II aleatorizado, doble ciego y controlado con placebo, para evaluar la seguridad y la eficacia de BMS-986165 en pacientes con enfermedad de Crohn de moderada a grave
    A.4.1Sponsor's protocol code numberIM011023
    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 SponsorBristol-Myers Squibb international Corporation
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBristol-Myers Squibb Research and Development
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointGCT-SU
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.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 nameBMS-986165
    D.3.2Product code BMS-986165
    D.3.4Pharmaceutical form Capsule
    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 INNBMS-986165
    D.3.9.1CAS number 1609392-28-0
    D.3.9.3Other descriptive nameBMS986165
    D.3.9.4EV Substance CodeSUB180283
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 placeboCapsule
    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
    Crohn's Disease
    Enfermedad de Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn’s disease is a chronic inflammatory disease of the gastrointestinal tract that causes significant morbidity, impact on quality of life, and health care expenditures.
    La Enfermedad de crohn es una enfermedad inflamatoria crónica del tracto intestinaal causante de una morbilidad significativa, impacto en la calidad de vida y gastos de atencion medica
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10011398
    E.1.2Term Crohn's
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Objective: To assess the effect of BMS-986165 on clinical remission and endoscopic response at the end of the Induction Period
    • Objetivo: evaluar el efecto de BMS-986165 sobre la remisión clínica y la respuesta endoscópica al final del período de inducción
    E.2.2Secondary objectives of the trial
    • Objective: To assess the effect of BMS-986165 on endoscopic remission at Week 12 (Day 85)
    • Objective: To assess the effect of BMS-986165 on clinical response at end of the Induction Period (Week 12 [Day 85])
    • Objective: To assess the effect of BMS-986165 on clinical response through end of the Maintenance Period (Week 52 [Day 365])
    • Objective: To assess the effect of BMS-986165 on clinical remission through the end of the Maintenance Period (Week 52 [Day 365])
    • Objective: To endoscopically assess the effect of BMS-986165 on gut mucosal disease activity
    • Objective: To assess the effect of BMS-986165 on deep remission
    • Evaluar el efecto de BMS-986165 sobre la remisión endoscópica en la semana 12 (día 85).
    • Evaluar el efecto de BMS-986165 sobre la respuesta clínica al final del período de inducción (semana 12 [día 85]).
    • Evaluar el efecto de BMS-986165 sobre la respuesta clínica hasta el final del período de mantenimiento (semana 52 [día 365]).
    • Evaluar el efecto de BMS-986165 sobre la remisión clínica hasta el final del período de mantenimiento (semana 52 [día 365]).
    • Evaluar mediante endoscopia el efecto de BMS-986165 sobre la actividad de la enfermedad a nivel de la mucosa intestinal.
    • Evaluar el efecto de BMS-986165 sobre la remisión profunda.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Signed Written Informed Consent
    a)Willing to participate in the study and sign the ICF
    b)Willing and able to complete all study-specific procedures and visits
    2)Type of Subject and Target Disease Characteristics
    a)Documented diagnosis of CD of at least 3 months’ duration,with colitis,ileitis, or ileocolitis,confirmed by:
    •Source:Medical records with report of an ileocolonoscopy(full colonoscopy with the intubation of terminal ileum)which shows features consistent with CD,as determined by the procedure performing physician,AND
    •Source:Medical record documentation of a histopathology report showing features consistent with CD,as determined by the local pathologist
    Note:If no previous confirmation of diagnosis is available or if previous diagnosis is not deemed conclusive,at time of baseline endoscopy,histology must be performed and read locally to confirm diagnosis of CD before proceeding to randomization
    b)Must have active moderate to severe CD,as defined by:
    •CDAI score of 220 to 450 AND
    •PRO 2:Average daily score for abdominal pain ≥2 OR average daily number of very soft(loose)or liquid (watery)stools(BSS Type 6 or 7 only)≥ 4,as collected in a 7-day diary,AND
    •Evidence of active inflammation in at least 1 of the 5 ileocolonic segments(based on central reading) with total SES-CD≥6 or SES-CD≥4 if only isolated ileitis is present on baseline endoscopy
    c)Must have had an inadequate response, loss of response, or intolerance to a standard treatment course of 1 or more of the following standard of care medications as below:
    •Oral aminosalicylates(eg,mesalamine,sulfasalazine,olsalazine,balsalazine)at or above the approved label dose for induction therapy for at least 6 weeks prior to randomization
    •Oral CS:Prednisone 20mg/day or equivalent for at least 2 weeks,and/or 2 failed attempts to taper oral CS below prednisone or equivalent 10mg daily
    •IV Corticosteroids: hydrocortisone≥400mg/day or equivalent for at least 1 week,
    •Immunomodulators (AZA≥2mg/kg/day,6-MP≥1mg/kg/day,MTX≥25mg/week,or documentation of a therapeutic concentration of 6 thioguanine nucleotide) for at least 12 weeks,or
    •Biologics(eg,infliximab,adalimumab,certolizumab pegol,vedolizumab,natalizumab)Subjects can be included if treatment with a biologic was stopped due to primary(eg,did not respond initially after treatment for at least 12 weeks at the approved dose)or secondary nonresponse(responded initially but then lost response with continued therapy)or were intolerant to treatment.
    d)This study permits the rescreening of a subject that has been deemed as ineligible(screen failure) during the Screening Period(ie,subject has not been randomized/has not been treated; ection 6.5)If re enrolled,the subject must be re-consented(ie,re-signing of the ICF)and rescreened(if outside the 28-day Screening Period window)Only 1 re enrollment per subject is permissible
    3)Age and Reproductive Status
    a)Men and women subjects,aged 18 to 75 years inclusive at the time of screening
    b)Women of childbearing potential(WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25IU/L or equivalent units of beta-human chorionic gonadotropin)within 24 h prior to the start of study treatment,unless they are surgically sterile had a hysterectomy,or have been postmenopausal for at least 1 year(12 consecutive months without menses)In case of doubt,a determination of serum follicle-stimulating hormone(FSH)can be performed with FSH levels>35mIU/mL confirming menopause status.
    c)Women must not be breastfeeding
    d)WOCBP must agree to follow instructions for method(s)of contraception for the duration of treatment with study treatment(s)BMS 986165(36 weeks)plus 5 half-lives of study treatment BMS986165(3 days)plus 30 days(duration of ovulatory cycle)for a total of 33 days post treatment completion
    e)WOCBP who are not heterosexually active are exempt from contraceptive requirements,and still must undergo pregnancy testing as described in this section
    f)Investigators shall counsel WOCBP and men on the importance of pregnancy prevention and the implications of an unexpected pregnancy.Investigators shall advise on the use of highly effective methods of contraception,which have a failure rate of<1% when used consistently and correctly
    g)Men who are sexually active with WOCBP must agree to follow instructions for method(s)of contraception for the duration of treatment with study treatment(s)plus 5 half-lives of the study treatment(3 days)after the final dose of study treatment
    h)Azoospermic males are exempt from contraceptive requirements.WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements,and still must undergo pregnancy testing as described in this section
    i)Male subjects must be willing to refrain from sperm donation during the entire duration of treatment plus 5 half-lives of study treatment(3 days)after the final dose of study treatment
    1)Consentim informado por escrito y firmado
    a)Disposición a participar en estudio y firmar CI
    b)Disposición y capacidad para realizar todas las visitas y procedim espec de estudio
    2)Tipo de pte y caract de enfermedad objeto de estudio
    a)Diagnóstico documentado de EC de al menos 3 meses de duración,con colitis,ileitis o ileocolitis,confirmado por:
    •Documento original:historia clínica con informe de ileocolonoscopia(colonoscopia completa con intubación del íleon terminal),que muestre caract compatibles con EC determinadas por el médico que realizó el procedim Y
    •Documento original:documentación en historia clínica de informe histopatológico que muestre caract compatibles con EC determinadas por anatomopatólogo local
    Nota:Si no dispone de confirmación previa de diag,o no se considera concluyente un diag previo,en el momento de endoscopia inicial se deberá realizar,e interpretar localmente,estudio histológico para confirmar diag de EC antes de aleatorización
    b)Presentar EC activa de moderada a grave,definida por:
    •puntuación CDAI 220-450,Y
    •RCP 2:Puntuación diaria promedio de dolor abdominal≥2,O BIEN frecuencia diaria promedio de heces muy blandas(sueltas)o líquidas(acuosas)(BSS 6 o 7 solamente)≥4,según registro en diario de 7 días,Y
    •Indicios e inflamación activa en al menos 1 de los 5 segmentos ileocolónicos(según interpretación central)con SES-CD≥6,o SES-CD≥4 si en la endoscopia inicial solo se halla presente ileitis aislada
    c)Debe haber presentado respuesta inadecuada,pérdida de respuesta o intolerancia a ciclo de tto de referencia con 1 o más de los siguientes medicam del tto de referencia como sigue:
    •aminosalicilatos orales(ej:mesalamina,sulfasalazina,olsalazina,balsalazina)a dosis de ficha téc aprobada para tto de inducción,o dosis superior,durante al menos 6 sem antes de aleatorización
    •CS oral:prednisona 20mg/día o equiv durante al menos 2 sem;y/o 2 intentos fallidos para disminuir el CS oral por debajo de prednisona o equivalente 10mg/dia
    •Conrticoides IV:hidrocortisona IV≥400mg/día o equiv durante al menos 1 sem;
    •inmunomoduladores(AZA≥2mg/kg/día,6-MP≥1mg/kg/día,MTX≥25mg/sem,o concentración terapéutica documentada de nucleótido de 6-tioguanina)durante al menos 12 sem;o
    •medicam biológicos(ej:infliximab,adalimumab,certolizumab pegol,vedolizumab, natalizumab)Se podrá incluir a ptes cuyo tto con un medicam biológico se haya interrumpido debido a falta de respuesta primaria(ej:no responden inicialmente tras tto durante al menos 12 sem a dosis autorizada)o secundaria(que respondieran inicialmente pero después perdieran la respuesta con tto continuado)o que hayan presentado intolerancia al tto.
    d)En este estudio se permite volver a someter a selecc a un pte considerado no apto(error de selecc)durante la selecc(esto es,pte no aleatorizado/no tratado;sección 6.5)Si vuelve a ser incluido,el pte deberá prestar de nuevo CIvy ser sometido de nuevo a selecc(si ha finalizado el intervalo de 28 días de la fase de selecc).Solo se permite una nueva inclusion por pte.
    3)Edad y estado reproductivo
    a Hombres y mujeres entre 18 y 75 años en el momento de la selecc
    b)Las mujeres potencialmente fértiles(MPF)deberán hacerse prueba de embarazo en orina o suero negativa(sensibilidad mínima,25UI/l o unidades equiv de gonadotropina coriónica humana-beta)en 24 h anteriores al inicio del tto de estudio,salvo que sean quirúrgicamente estériles,se hayan sometido a histerectomía o hayan sido postmenopáusicas durante al menos 1 año(12 meses consecutivos sin menstruaciones)En caso de duda se podrá llevar a cabo determinación FSH para confirmar estado menopáusico con niveles de FSH>35mUI/ml
    c)Las mujeres no podrán estar amamantando
    d)Las MPF deben estar conformes en seguir instrucc relativas a métodos anticonceptivos mientras reciban el/los tto(s)de estudio BMS986165(36 sem)más 5 semividas de tto de estudio BMS986165(3 días)y 30 días(duración del ciclo ovulatorio):total de 33 días tras conclusión de estudio
    e)Las MPF que no sean activas heterosexualmente están exentas de cumplir requisitos relativos a métodos anticonceptivos,ademas deben someterse a pruebas de embarazo explicadas en esta secc
    h)Los investigadores asesorarán a MPF y hombres sobre la importancia de evitar embarazo e implicaciones de embarazo no planificado.Los investigadores facilitarán asesoramiento sobre uso de métodos anticonceptivos de alta eficacia,con tasa de error <1%cuando se utilizan de forma sistemática y correcta
    g)Los hombres sexualmente activos con MPF deben aceptar seguir instrucciones para el(los)métodos anticonceptivos durante el tto con BMS-986165 o placebo más 5 semividas de estudio de tto(3 días)después de dosis final de tto de estudio
    g)Los hombres azoospérmicos están exentos de cumplir requisitos anticonceptivos
    f)Los sujetos varones deben estar dispuestos a abstenerse de la donación de esperma durante toda la duración del tto más 5 semividas del tto de estudio(3 días)después de la última dosis del tto de estudio
    E.4Principal exclusion criteria
    1) Target Population
    a) Severe or fulminant colitis that is likely to require surgery or hospitalization
    b) Presence of a diagnosis of alternative forms of colitis (infectious, inflammatory including ulcerative colitis, malignant, toxic, indeterminate, etc.) other than CD
    c) Presence of a stoma, gastric or ileoanal pouch, previous proctocolectomy or total colectomy, symptomatic obstructive disease such as stenosis or obstructive strictures, abscess or suspected abscess, pouchitis, short bowel syndrome, or history of bowel perforation
    d) History of intra-abdominal abscess within the last 60 days
    • Previous intra-abdominal abscess that has been drained and successfully treated with a local standard course of antimicrobial therapy is permitted (The course must have completed at least 60 days prior to Day 1)
    e)History of diverticulitis within the last 60 days
    • Previous diverticulitis that has been successfully treated with a local standard course of antimicrobial therapy is permitted. (The course must have completed at least 60 days prior to Day 1)
    f) Receiving tube feeding, defined formula diets, or total parenteral alimentation
    g) Current colonic dysplasia or past colonic dysplasia that has not been definitively treated
    h) History of infectious (bacterial, viral, fungal, parasitic, etc.) colitis within past 30 days; must be fully treated to rescreen
    i) Use of therapeutic enema or suppository, other than required for ileocolonoscopy, within 7 days prior to screening or during the Screening Period
    j) Prior treatment with specific lymphocyte-depleting agents, such as alemtuzumab, rituximab, and other agents such as ustekinumab, are prohibited within 12 months prior to the first dose of study treatment during the Induction Period. Please note that lack of response to ustekinumab (as well as other anti-12/23 p40 antibodies) or anti-IL-23 p19 antibodies is criteria for exclusion (also see exclusion criterion 3.b).
    k) Receipt of either lymphocyte apheresis or selective monocyte, granulocyte apheresis (eg, Cellsobra®) is prohibited within 12 months prior to the first dose of study treatment during the Induction Period
    l) Previous exposure to BMS-986165 in any study
    m) Previous stem cell transplantation
    n) Previous treatment with investigational agents within 12 weeks or 5 half-lives (whichever is longer) prior to the first dose of study treatment during the Induction Period
    1) Población del estudio
    a) Colitis grave o fulminante que probablemente requiera cirugía u hospitalización
    b) Existencia de un diagnóstico de formas alternativas de colitis (colitis infecciosa o inflamatoria, incluidas las colitis ulcerosas, malignas, tóxicas, indeterminadas, etc.) distintas de la EC
    c) Presencia de un estoma, bolsa gástrica o ileoanal, proctocolectomía o colectomía total previa, enfermedades obstructivas tales como estenosis o estenosis obstructivas sintomáticas, absceso o sospecha de absceso, bolsitis, síndrome de intestino corto o historial de perforación intestinal
    d) Historial de absceso intraabdominal en los últimos 60 días
    • Se permite el absceso intraabdominal previo drenado y tratado con éxito con un ciclo del tratamiento antimicrobiano local de referencia (el ciclo debe haber finalizado al menos 60 días antes del día 1)
    e) Historial de diverticulitis en los últimos 60 días
    • Se permite la diverticulitis previa tratada con éxito con un ciclo del tratamiento antimicrobiano local de referencia. (El ciclo debe haber finalizado al menos 60 días antes del día 1)
    f) Recibir alimentación por sonda, dietas de fórmula definida o alimentación parenteral total
    g) Displasia de colon actual o pasada que no haya sido tratada definitivamente
    h) Historial de colitis infecciosa (bacteriana, vírica, fúngica, parasitaria, etc.) en los últimos 30 días; para repetir la selección debe ser tratada por completo.
    i) Uso de un enema o supositorio, distintos de los requeridos para la ileocolonoscopia, en los 7 días previos a la selección o durante esa fase.
    j) Está prohibido el tratamiento previo con agentes específicos reductores de linfocitos, como alemtuzumab, rituximab, y otros agentes como ustekinumab, en los 12 meses anteriores a la primera dosis del tratamiento del estudio durante el período de inducción. Debe tenerse en cuenta que la falta de respuesta a ustekinumab (y a otros anticuerpos anti-p40 de IL-12/IL-23) o a anticuerpos anti-p19 de IL-23 constituye un criterio de exclusión (ver también criterio de exclusión 3.b).
    k) Está prohibido recibir aféresis de linfocitos o aféresis selectiva de monocitos y granulocitos (p. ej., Cellsobra®) en los 12 meses anteriores a la primera dosis del tratamiento del estudio durante el período de inducción
    i) Exposición previa a BMS-986165 en cualquier estudio
    m) Trasplante previo de células madre
    n) Tratamiento previo con agentes en fase de investigación en el período de 12 semanas o (si constituye un período más largo) de 5 semividas anterior a la primera dosis del tratamiento del estudio durante el período de inducción
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary endpoints:
    Proportion of subjects achieving clinical remission at Week 12 (Day 85)
    Proportion of subjects achieving endoscopic response at Week 12 (Day 85)
    o Proporción de pacientes que logran la remisión clínica en la semana 12 (día 85).
    o Proporción de pacientes que logran la respuesta endoscópica en la semana 12 (día 85).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 semanas
    E.5.2Secondary end point(s)
    o Endpoint: Proportion of subjects who achieve endoscopic remission at Week 12 (Day 85)
    o Endpoint: Proportion of subjects who achieve a clinical response at Week 12 (Day 85)
    o Endpoint: Proportion of subjects who achieve a clinical response through Week 52 (Day 365)
    o Endpoint: Proportion of subjects achieving clinical remission at Week 52 (Day 365)
    o Endpoints:
    Proportion of subjects achieving endoscopic remission at Week 52 (Day 365)
    Proportion of subjects who achieve an endoscopic response at Week 52 (Day 365)
    Proportion of subjects achieving complete mucosal healing at Weeks 12 and 52
    Change from baseline in SES-CD at Weeks 12 and 52

    o Endpoints:
    Proportion of subjects achieving deep remission at Week 12 (Day 85)
    Proportion of subjects maintaining deep remission at Week 52 (Day 365)
    o Criterio de valoración: Proporción de pacientes que alcanzan la remisión endoscópica en la semana 12 (día 85)
    o Criterio de valoración: Proporción de pacientes que alcanzan una respuesta clínica en la semana 12 (día 85)
    o Criterio de valoración: Proporción de pacientes que alcanzan una respuesta clínica hasta la semana 52 (día 365)
    o Criterio de valoración: Proporción de pacientes que alcanzan la remisión clínica en la semana 52 (día 365)
    o Criterios de valoración:
    Proporción de pacientes que alcanzan la remisión endoscópica en la semana 52 (día 365)
    Proporción de pacientes que alcanzan una respuesta endoscópica en la semana 52 (día 365)
    Proporción de pacientes que consiguen una cicatrización completa de la mucosa en las semanas 12 y 52
    Cambio con respecto al inicio en el SES-CD en las semanas 12 y 52

    o Criterios de valoración:
    Proporción de pacientes que alcanzan una remisión profunda en la semana 12 (día 85)
    Proporción de pacientes que mantienen la remisión profunda en la semana 52 (día 365)
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 and 52 weeks
    semanas 12 y 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 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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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
    Australia
    Brazil
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Korea, Republic of
    Mexico
    Poland
    Romania
    Spain
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Ultima visita del ultimo paciente
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state145
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 144
    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)
    For subjects who achieve clinical response at Week 12 (Day 85), and who were taking CS during the Induction Period, CS dose tapering and withdrawal will be initiated during the Maintenance Period using a suggested standardized reduction regimen. In addition, subjects who switch to open-label treatment at the highest dose level (12 mg QD) at Week 12 but achieve a clinical response at Week 26 (Day 183) will also go through CS tapering at Week 26 (Day 183) if they are still on CS treatment.
    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 Decision2018-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-09
    P. End of Trial
    P.End of Trial StatusOngoing
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