Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7259   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-002308-11
    Sponsor's Protocol Code Number:IM047-001
    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:2022-07-21
    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 number2021-002308-11
    A.3Full title of the trial
    A phase 2/3, multicenter, randomized, double-blind study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of oral ozanimod (RPC1063) in pediatric subjects with moderately to severely active ulcerative colitis with an inadequate response to conventional therapy.
    Estudio fases 2/3, multicéntrico, aleatorizado, doble ciego para evaluar la eficacia, seguridad, farmacocinética y farmacodinamia de ozanimod oral (RPC1063) en pacientes pediátricos con colitis ulcerosa activa de moderada a grave con respuesta insuficiente al tratamiento convencional
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2/3, multicenter, randomized, double-blind study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of oral ozanimod (RPC1063) in pediatric subjects with moderately to severely active ulcerative colitis with an inadequate response to conventional therapy.
    Estudio fases 2/3, multicéntrico, aleatorizado, doble ciego para evaluar la eficacia, seguridad, farmacocinética y farmacodinamia de ozanimod oral (RPC1063) en pacientes pediátricos con colitis ulcerosa activa de moderada a grave con respuesta insuficiente al tratamiento convencional
    A.4.1Sponsor's protocol code numberIM047-001
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1268-2191
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/233/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCelgene International II Sàrl
    B.1.3.4CountrySwitzerland
    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 supportCelgene Corporation
    B.4.2CountryUnited States
    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 pointGSM-CT
    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 nameOzanimod HCL
    D.3.2Product code RPC1063
    D.3.4Pharmaceutical form Capsule, hard
    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 INNOzanimod HCL
    D.3.9.1CAS number 1618636-37-5
    D.3.9.3Other descriptive nameRPC1063
    D.3.9.4EV Substance CodeSUB175614
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.23
    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 nameOzanimod HCL
    D.3.2Product code RPC1063
    D.3.4Pharmaceutical form Capsule, hard
    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 INNOzanimod HCL
    D.3.9.1CAS number 1618636-37-5
    D.3.9.3Other descriptive nameRPC1063
    D.3.9.4EV Substance CodeSUB175614
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.46
    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: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOzanimod HCL
    D.3.2Product code RPC1063
    D.3.4Pharmaceutical form Capsule, hard
    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 INNOzanimod HCL
    D.3.9.1CAS number 1618636-37-5
    D.3.9.3Other descriptive nameRPC1063
    D.3.9.4EV Substance CodeSUB175614
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.92
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderately to Severely Active Ulcerative Colitis
    colitis ulcerosa activa de moderada a grave
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    Colitis ulcerosa
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of ozanimod in pediatric subjects with moderately to severely active UC (3-component Mayo Score: clinical remission, Week 52)
    evaluar la eficacia de ozanimod (RPC1063) en pacientes pediátricos con CU activa de moderada a grave (puntuación de Mayo de 3 componentes: remisión clínica, semana 52).
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of ozanimod in pediatric subjects with moderately to severely active UC (3-component Mayo Score: clinical remission, Week 10)
    evaluar la eficacia de ozanimod (RPC1063) en pacientes pediátricos con CU activa de moderada a grave (puntuación de Mayo de 3 componentes: remisión clínica, semana 10).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age ≥ 2 and < 17 years of age
    -Have had UC diagnosed prior to the Screening Visit. The diagnosis should be confirmed by clinical and endoscopic evidence and corroborated by a histopathology report
    -Evidence of UC extending beyond the rectum, as determined by baseline endoscopy
    -Has moderately to severely active UC, defined as a 4-component Mayo Score ≥ 6 and ≤ 12 at the time of screening, including the following: Mayo Endoscopy Subscore ≥ 2, Rectal Bleeding Score ≥ 1, and Stool Frequency Score ≥ 1.
    -Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy
    -Subjects may concurrently receive treatment with oral 5-ASAs, or with prednisone or equivalent (≤ 0.5 mg/kg/ day up to 20 mg/day).
    -Must have documentation of vaccinations per standard immunization schedule including complete Varicella zoster virus (VZV) vaccination at least 30 days prior to randomization, or documentation of positive Varicella zoster virus (VZV) Immunoglobulin G (IgG) antibody.
    -Females of childbearing potential (FCBP)[1] must agree to practice a highly effective method of contraception[2] throughout the study until completion of the 90-day Safety Follow-up Visit.
    - Edad ≥ 2 y < 17 años de edad
    - Haber sido diagnosticado de CU antes de la visita de selección. El diagnóstico debe ser confirmado mediante pruebas clínicas y endoscópicas y corroborado por un informe histopatológico
    - Evidencia de CU que se extiende más allá del recto, determinado en la endoscopia inicial
    - Tener CU activa de moderada a grave, definida como una puntuación de Mayo de 4 componentes ≥ 6 y ≤ 12 en el momento de la selección, incluidos los siguientes: Subpuntuación de la endoscopia de Mayo ≥ 2, puntuación de sangrado rectal ≥ 1 y puntuación de frecuencia de deposiciones ≥ 1.
    - Haber tenido una respuesta inadecuada, pérdida de respuesta, o intolerancia a al menos 1 de los siguientes tratamientos para la CU: aminosalicilatos orales, corticosteroides sistémicos, inmunomoduladores, terapia biológica
    - Los sujetos pueden recibir simultáneamente tratamiento con 5-ASA orales, o con prednisona o equivalente (≤ 0,5 mg/kg/día hasta 20 mg/día
    - Vacunación documentada según el programa de vacunación estándar, incluida la vacuna contra la varicela completa al menos 30 días antes de la aleatorización o tener documentado ser positivo en Inmunoglobulina G (IgG) del virus varicela zoster
    - Las mujeres en edad fértil (MEF)1 deben aceptar utilizar un método anticonceptivo muy efectivo2 durante todo el estudio hasta completar la visita de seguimiento de seguridad de 90 días.
    E.4Principal exclusion criteria
    -Clinically relevant cardiovascular, hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study
    -Diagnosis of Crohn’s disease, indeterminate colitis or the presence or history of a fistula consistent with Crohn’s disease or microscopic colitis, radiation colitis or ischemic colitis.
    -Has documentation of positive test for toxin producing Clostridium difficile (C. difficile), or polymerase chain reaction (PCR) examination of the stool. If positive, subjects may be rescreened after appropriate treatment and retested no earlier than 7 days after completion of treatment.
    -History of treatment with topical rectal 5-aminosalicylic acid or topical rectal steroids within 2 weeks of Screening endoscopy or anti-motility medications (such as diphenoxylate/atropine) during Screening.
    -Apheresis within 2 weeks of randomization.
    -Pregnancy, lactation, or a positive serum beta human chorionic gonadotropin (β-hCG) measured during Screening.
    -History or presence of the following clinically relevant cardiovascular conditions:
    •Structural cardiac disease
    •Cardiac events or diseases that predispose to cardiac complications
    •Prolonged QT interval corrected for heart rate or is at additional risk for QT interval prolongation During either Screening or Baseline Day 1 pre-dose assessmsnt, resting HR < 55 bpm in subjects 12-17 years old, resting HR < 65 bpm in subjects 6-11 years old, or resting HR < 75 bpm in subjects 2-5 years old.
    •Severe untreated sleep apnea
    -History of diabetes mellitus (DM)
    -History of uveitis or history or evidence of retinal disease.
    -Subject has any known active bacterial, viral, fungal, mycobacterial infection or any major episode infection that required hospitalization or treatment with IV antibiotics within 30 days of Screening or oral antibiotics within 14 days of screening.
    -Recurrent or chronic infection recurrent urinary tract infections are allowed.
    -Any history of cancer, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin or cervical dysplasia/cancer that have been excised and resolved) or colonic dysplasia that has not been completely removed.
    -History of or currently active primary or secondary immunodeficiency, or subjects with known genetic disorders as a cause for colitis
    Exclusions related to laboratory abnormalities (at time of screening visit):
    -ECG showing any clinically significant abnormality.
    -Serum creatinine > 1.4 mg/dL for females, or > 1.6 mg/dL for males.
    -Liver function impairment; or, persisting elevations of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x upper limit of normal (ULN); or, direct bilirubin > 1.5x ULN.
    -Platelet count < 100,000/μL.
    -Hemoglobin < 8.0 g/dL..
    -Neutrophil count < 1500/μL.
    -Absolute white blood count < 3500/μL.
    -ALC < 800/μL.
    -Stool positive for pathogens.
    -In subjects with recent pulmonary function test measurements: (FEV1) or (FVC) at < 70% of predicted values.
    Exclusions related to medications
    -Hypersensitivity to active ingredients or excipients of ozanimod.
    -Treated with a biologic agent or 5 elimination half-lives (whichever is shorter) prior to the first dose of IP.
    -Treated with an investigational agent
    -Received a live or live attenuated vaccine
    -Received any previous treatment with lymphocyte-depleting therapies
    -Received treatment with D-penicillamine, leflunomide, or thalidomide
    -Received previous treatment with natalizumab, fingolimod, or other S1P receptor modulators.
    -History of treatment with IV immune globulin (IVIg), or plasmapheresis
    -Received previous treatment with oral cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil
    -Planned concurrent treatment with immunomodulatory agents after randomization.
    -Chronic nonsteroidal anti-inflammatory drug (NSAID) use
    -Receiving treatment with Class Ia or Class III anti-arrhythmic drugs or with 2 or more agents in combination known to prolong PR interval.
    -Receiving treatment with breast cancer resistance protein (BCRP) inhibitors
    -Received cholestyramine or other drugs interfering with enterohepatic circulation within 3 weeks of Screening.
    -Receiving treatment with any of the following drugs or interventions within the corresponding timeframe:
    -At randomization: CYP2C8 inhibitors and inducers
    -Two weeks prior to randomization: Monoamine oxidase inhibitors
    -Enfermedad cardiovascular, hepática, neurológica, pulmonar, oftalmológica, endocrina, psiquiátrica u otra enfermedad sistémica importante clínicamente relevante que dificulte la implementación del protocolo o la interpretación del estudio o que ponga al sujeto en riesgo al participar en el estudio.
    -Diagnóstico de enfermedad de Crohn, colitis indeterminada o presencia o antecedentes de una fístula compatible con enfermedad de Crohn o colitis microscópica, colitis por radiación o colitis isquémica
    -Prueba positiva documentada para la toxina que C. difficile, o análisis mediante PCR de las heces Si es +, los sujetos pueden volver a seleccionarse después del tratamiento adecuado y repetir la prueba no antes de los 7 días posteriores a la finalización del tratamiento
    -Antecedentes de tratamiento con ácido 5-aminosalicílico rectal tópico o esteroides rectales tópicos en las 2 semanas anteriores a la endoscopia de la selección o medicamentos contra la motilidad durante la selección
    -Aféresis en las 2 semanas anteriores a la aleatorización
    -Embarazo, lactancia o b-hCG sérica + medida durante la selección
    -Antecedentes o presencia de las siguientes afecciones cardiovasculares:
    *Enfermedad cardíaca estructural
    *Acontecimientos cardíacos o enfermedades que predisponen a complicaciones cardíacas
    *Intervalo QT prolongado corregido para la frecuencia cardíaca utilizando la fórmula de Fridericia (QTcF) > 450 ms para hombres y mujeres (ya sea en la selección o en la evaluación previa a la dosis del día 1), o con un riesgo adicional de prolongación del intervalo QT. Durante la selección o la evaluación previa a la dosis del día 1 de selección basal, FC en reposo < 55 lpm en sujetos de 12 a 17 años, FC en reposo < 65 lpm en sujetos de 6 a 11 años o FC en reposo < 75 lpm en sujetos de 2 a 5 años.
    *Apnea del sueño grave no tratada
    -Antecedentes de diabetes mellitus
    -Antecedentes de uveítis, o antecedentes o evidencia de enfermedad retiniana
    -El sujeto tiene cualquier infección activa conocida bacteriana, vírica, fúngica, infección micobacteriana, o cualquier episodio importante de infección que requirió hospitalización o tratamiento con antibióticos IV en los 30 días anteriores a la selección o antibióticos orales en los 14 días anteriores a la selección
    -Infección recurrente o crónica; se permiten infecciones recurrentes de las vías urinarias
    -Cualquier antecedente de cáncer, incluidos tumores sólidos y neoplasias hematológicas (excepto carcinomas de células basales y de células escamosas in situ de la piel o displasia/cáncer de cuello uterino que se hayan extirpado y resuelto) o displasia colónica que no se haya extirpado por completo.
    -Antecedentes de inmunodeficiencia primaria o secundaria actualmente activa o sujetos con trastornos genéticos conocidos como causa de colitis
    Exclusiones relacionadas con valores anormales de laboratorio (en el momento de la visita de selección):
    *ECG que muestra cualquier anormalidad clínicamente significativa.
    *Creatinina sérica > 1,4 mg/dl para mujeres, o > 1,6 mg/dl para hombres
    *Pruebas de la función hepática; o elevaciones persistentes de la ALT o la AST > 2 veces el LSN; o, bilirrubina directa > 1,5x LSN.
    *Recuento de plaquetas < 100.000/μl
    *Hemoglobina < 8,0 g/dl
    *Recuento de neutrófilos < 1500/μl
    *Recuento absoluto de leucocitos < 3500/μl
    *ALC < 800/μl
    *Heces positivas para patógenos
    *Mediciones de las pruebas de la función pulmonar en la selección: FEV1 o una CVF en < 70% de los valores predichos
    Exclusiones relacionadas con las medicaciones
    *Hipersensibilidad a los principios activos o excipientes de ozanimod.
    *Tratamiento con un agente biológico 8 semanas o 5 semividas de eliminación (lo que sea más corto) antes de la primera dosis del PI
    *Tto con un agente en investigación
    *Vacunación con una vacuna viva o atenuada
    *Tto previo con terapias de reducción de linfocitos
    *Tto con D-penicilamina, leflunomida o talidomida
    *Tto previo con natalizumab, fingolimod u otros moduladores del receptor S1P
    *Antecedentes de tratamiento con IVIg o plasmaféresis en los 3 meses anteriores a la primera dosis del PI
    *Tratamiento previo con ciclosporina oral, tacrolimus, sirolimus o micofenolato mofetilo
    *Tto simultáneo planificado con agentes inmunomoduladores después de la aleatorización
    *Uso crónico de antiinflamatorios no esteroideos (AINE)
    *Tto con antiarrítmicos de Clase Ia o Clase III o con 2 o más agentes en combinación que se sabe que prolongan el intervalo PR
    *Tto con inhibidores de la proteína de resistencia al cáncer de mama (BCRP)
    *Tto con colestiramina u otros medicamentos que interfieren con la circulación enterohepática en las 3 semanas anteriores a la selección.
    *Tto con alguno de los siguientes fármacos o intervenciones en el período de tiempo correspondiente:
    En la aleatorización: inhibidores e inductores de CYP2C8
    Dos semanas antes de la aleatorización: inhibidores de la monoamino oxidasa
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects who achieve clinical remission, defined as all the following:
    • Mayo Endoscopy Subscore (MES) ≤ 1
    • Rectal Bleeding Subscore (RBS) = 0
    • Stool Frequency Subscore (SFS) ≤ 1, with a decrease of ≥ 1 point from Baseline SFS
    Porcentaje de pacientes que alcanzan la remisión clínica (puntuación de Mayo de 3 componentes), definida como todo lo siguiente:
    • Subpuntuación de endoscopia de Mayo (MES) ≤ 1
    • Subpuntuación de sangrado rectal (RBS) = 0
    • Subpuntuación de frecuencia de deposiciones (SFS) ≤ 1, con una disminución de ≥ 1 punto respecto a la SFS basal
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Semana 52
    E.5.2Secondary end point(s)
    1/Proportion of subjects who achieve clinical response defined as all the following:
    • Decrease from Baseline in the 3-component Mayo score of at least 2 points and at least 35%
    • Decrease in RBS of at least 1 point OR absolute RBS ≤ 1
    2/Proportion of subjects who achieve clinical remission defined as all the following:
    • MES ≤ 1
    • RBS = 0
    • SFS ≤ 1, with a decrease of ≥1 point from Baseline SFS
    3/Proportion of subjects who achieve symptomatic improvement of UC, defined as all the following:
    • RBS = 0
    • SFS ≤ 1
    • Decrease in SFS of ≥ 1 from Baseline
    4/Proportion of subjects who achieve endoscopic improvement, defined as MES ≤ 1
    5/Proportion of subjects who achieve corticosteroid-free remission at Week 52, defined as all the following:
    • Did not receive steroids for ≥ 12 weeks prior to Week 52
    • Achieved clinical remission defined by the 3-component Mayo score
    6/Secondary – Safety and Tolerability
    Number and proportion of subjects experiencing AEs, SAEs, AEs leading to discontinuation from treatment, and AEs of interest (AEIs)
    7/Secondary - Pharmacokinetics
    Steady state systemic exposure of ozanimod and CC112273
    8/Secondary – Pharmacodynamics
    Absolute and percent change from baseline in ALC
    1/Porcentaje de pacientes que alcanzan remisión clínica definida por lo siguiente:
    - Reducción desde el baseline en la puntuación de Mayo de 3 componentes de al menos 2 puntos y por lo menos 35%
    - Reducción de RBS de al menos 1 punto o de RBS absoluto ≤ 1
    2/ Proporción de pacientes que alcanzan remisión clínica definida por lo siguiente:
    -MES ≤ 1
    -RBS=0
    -SFS≤ 1, con una reducción de ≥1punto desde el baseline SFS
    3/Proporción de pacientes que alcanzan mejoría sintomática de CU definida por lo siguiente:
    -RBS=0
    -SFS≤ 1
    -Reducción SFS de ≥ desde el basal
    4/Porcentaje de pacientes que alcanzan la mejora endoscópica, definida como MES ≤ 1
    5/Porcentaje de pacientes que alcanzan la remisión sin corticosteroides en la semana 52 definida por lo siguiente:
    - no recibieron esteroides durante ≥ 12 semanas antes de la semana 52
    - Consiguieron remisión clínica definida por la puntuación de Mayo de 3 componentes
    6/Secundario: Seguridad y Tolerabilidad
    Número y porcentaje de pacientes que experimentaron acontecimientos adversos (AA), acontecimientos adversos graves (AAG), AA que provocaron la interrupción del tratamiento y AA de especial interés (AAEI) durante todo el estudio
    7/Secundario: Farmacocinética
    Exposición sistémica en el estado estable de ozanimod y CC112273
    8/ Secundario: Farmacodinámica
    Cambio absoluto y porcentaje desde el basal en el ALC
    E.5.2.1Timepoint(s) of evaluation of this end point
    1/Week 10 and week 52
    2/Week 10
    3/Week 10 and week 52
    4/Week 10 and week 52
    5/Week 52
    6/throughout the study
    7/Week 18 and throughout the study
    8/Week 10 and week 52
    1/Semana 10 y semana 52
    2/Semana 10
    3/Semana 10 y semana 52
    4/Semana 10 y semana 52
    5/Semana 52
    6/Durante el estudio
    7/Semana 18 y durante el estudio
    8/Semana 10 y semana 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Canada
    Israel
    Japan
    United States
    France
    Poland
    Netherlands
    Spain
    Germany
    Belgium
    Russian Federation
    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
    Last patient Last visit
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days25
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 120
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 48
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 72
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 120
    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)
    Subjects who continue to demonstrate clinical benefit will be eligible to receive Celgene supplied study treatment for a maximum treatment duration as specified in Section 7.1. of the protocol.
    Los sujetos que continúen demostrando beneficio clínico serán elegibles para recibir el tratamiento del estudio suministrado por Celgene para un tratamiento máximo de duración especificada en la sección 7.1. del protocolo.
    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 Decision2022-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-14
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA