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    Summary
    EudraCT Number:2019-004021-25
    Sponsor's Protocol Code Number:IM026-024
    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:2021-08-25
    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 number2019-004021-25
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants with Active Systemic Lupus Erythematosus.
    Estudio fase 2, multicéntrico, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de BMS-986256 en pacientes con lupus eritematoso sistémico activo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Evaluating the Efficacy and Safety of BMS-986256 Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
    Eficacia y seguridad de BMS-986256 en comparación con placebo en pacientes con lupus eritematoso sistémico activo
    A.4.1Sponsor's protocol code numberIM026-024
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1241-6528
    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 International Corporation
    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 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.5.4Telephone number+ 34 91 456 53 00
    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 nameTLR7/8 Antagonist (2.5mg)
    D.3.2Product code BMS-986256
    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 INNNot available
    D.3.9.2Current sponsor codeBMS-986256
    D.3.9.3Other descriptive nameBMS-986256-06, TLR7/8 Antagonist
    D.3.9.4EV Substance CodeSUB206681
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 nameTLR7/8 Antagonist (10mg)
    D.3.2Product code BMS-986256
    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 INNNot available
    D.3.9.2Current sponsor codeBMS-986256
    D.3.9.3Other descriptive nameBMS-986256-06, TLR7/8 Antagonist
    D.3.9.4EV Substance CodeSUB206681
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Active Systemic Lupus Erythematosus.
    Lupus Eritematoso Sistémico Activo
    E.1.1.1Medical condition in easily understood language
    SLE is a chronic autoimmune disease in which the immune system attacks its own tissues, causing inflammation and tissue damage in the affected organs (skin, joints, kidneys, heart and other organs).
    LES:enfermedad crónica autoinmune en que el sistema inmune ataca sus propios tejidos,causando inflamación y daño tisular en los órganos afectados (piel,articulaciones,riñones,corazón y otros órganos).
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To assess the efficacy of BMS-986256 versus placebo using a composite measure of improvement in lupus activity that is primarily driven by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), in participants with active SLE
    - Evaluar la eficacia de BMS-986256 frente a placebo usando una medida compuesta de mejora en la actividad del lupus que está principalmente determinada por el SLEDAI, en pacientes con LES activo
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of BMS-986256 versus placebo using a composite measure of improvement in lupus activity with corticosteroids (CS) reduction and maintenance at a low level in participants with active SLE
    - To assess the efficacy of BMS-986256 versus placebo using an alternative composite measure of improvement in lupus activity that is primarily driven by the British Isles Lupus Assessment Group (BILAG), in participants in active SLE
    - To assess the efficacy of BMS-986256 versus placebo on measures of global and organ-specific clinical response in participants with active SLE
    - To assess the steroid-sparing effect of BMS-986256 versus placebo in participants with active SLE
    - To characterize patient-reported health status in participants with active SLE on BMS-986256
    - To assess the safety and tolerability of BMS-986256 versus placebo in participants with active SLE
    - Evaluar la eficacia de BMS-986256 frente a placebo usando una medida compuesta de mejora en la actividad del lupus con reducción de CS y mantenimiento a un nivel bajo en pacientes con LES activo
    - Evaluar la eficacia de BMS-986256 frente a placebo usando una medida compuesta de mejora en la actividad del lupus que está principalmente determinada por el BILAG-2004, en pacientes con LES activo
    - Evaluar la eficacia de BMS-986256 frente a placebo en las medidas de la respuesta clínica global y específica del órgano en pacientes con LES activo
    - Evaluar el efecto ahorrador de esteroides de BMS-986256 frente a placebo en pacientes con LES activo
    - Caracterizar el estado de salud comunicado por el paciente en pacientes con LES activo con BMS-986256
    - Evaluar la seguridad y tolerabilidad de BMS-986256 frente a placebo en pacientes con LES activo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Qualify as having Systemic Lupus Erythematosus (SLE), according to the SLE International Collaborating Clinics (SLICC) Classification Criteria ≥ 12 weeks before the screening visit
    - Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody>/= 1:80, anti-double-stranded deoxyribonucleic acid (dsDNA) antibody, or anti-Smith antibody.
    - Have a total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score ≥ 6 points and clinical Hybrid SLEDAI score ≥ 4 points with joint involvement and/or rash

    Other protocol-defined inclusion criteria apply.
    - Diagnóstico de LES de acuerdo con los Criterios de clasificación de las clínicas colaboradoras internacionales del LES (SLICC) ≥ 12 semanas antes de la visita de selección
    - Prueba con resultado positivo, determinado por un laboratorio central, para al menos 1 de los siguientes autoanticuerpos relacionados con el lupus: anticuerpo antinuclear ≥ 1:80, anticuerpo anti-ácido desoxirribonucleico de doble cadena (ADNdc) o anticuerpo anti-Smith
    - Tener una puntuación SLEDAI híbrida total ≥ 6 puntos y puntuación SLEDAI híbrida clínica ≥ 4 puntos con afectación articular y/o exantema;

    Pueden aplicar otros criterios de inclusión definidos en el protocolo
    E.4Principal exclusion criteria
    - Active severe lupus nephritis (LN) as assessed by the investigator
    - Neuropsychiatric lupus manifestations defined by the Hybrid SLEDAI
    - Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLE
    - Antiphospholipid Syndrome

    Other protocol-defined exclusion criteria apply.
    - Nefritis lúpica (NL) activa grave, según criterio del investigador
    - Manifestaciones neuropsiquiátricas del lupus, definidas acorde al SLEDAI Híbrido
    - Diagnóstico de enfermedad del Tejido Conectivo Mixto para la cual el diagnóstico predominante no es LES
    - Síndrome antifosfolipídico

    Pueden aplicar otros criterios de exclusión definidos en el protocolo
    E.5 End points
    E.5.1Primary end point(s)
    1. Proportion of participants who achieve an SLE Responder Index 4 (SRI[4]) response at Week 48
    1. Porcentaje de pacientes que alcanzan una respuesta SRI(4) en la semana 48
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to 48 weeks
    1. Hasta la semana 48
    E.5.2Secondary end point(s)
    1. Proportion of participants that achieve an SRI(4) response with corticosteroids (CS) reduction and maintenance to ≤ 7.5 mg per day at Week 48
    2. Proportion of participants that achieve a British Isles Lupus Assessment Group (BILAG)-based Combine Lupus Assessment (BICLA) at Week 24 and Week 48
    3. Proportion of participants who achieve an SRI(4) response without CS reduction and maintenance to ≤ 7.5 mg per day at Week 24
    4. Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response at Week 24 and Week 48
    5. Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index; Activity (CLASI-A) score ≥ 10 at baseline who achieve a decrease of ≥ 50% from baseline CLASI-A score (CLASI-50) response at Week 24 and Week 48
    6. Proportion of participants with 6 or more swollen joints and 6 or more tender joints at baseline who achieve a ≥ 50% reduction from baseline in both swollen and tender joints at Week 24 and Week 48
    7. Mean change from baseline in swollen joint count using the 28-joint count at Week 24 and Week 48 in participants with ≥ 2 swollen joints at baseline
    8. Mean change from baseline in tender joint count at Week 24 and Week 48 using the 28- joint count in participants with ≥ 2 tender joints at baseline
    9. Change from baseline in PGA score of disease activity at Week 24 and Week 48
    10. Proportion of participants who achieve CS reduction or maintenance to ≤ 7.5 mg per day at Week 48
    11. Change in patient reported disease activity from baseline to Week 24 and Week 48 according to the (36-item Short Form Health Questionnaire) SF-36
    12. Number of participants that experience Serious Adverse Events (SAEs)
    13. Proportion of participants that experience SAEs
    14. Number of participants that experience Adverse Events (AEs)
    15. Proportion of participants that experience AEs
    16. Number of participants that experience abnormalities or clinically important changes in clinical laboratory values (Hematology tests; Chemistry tests, Coagulation tests, Urinalysis tests, Serology tests)
    17. Proportion of participants that experience abnormalities or clinically important changes in clinical laboratory values (Hematology tests; Chemistry tests, Coagulation tests, Urinalysis tests, Serology tests)
    18. Number of participants that experience abnormalities or clinically important changes in physical examination
    19. Proportion of participants that experience abnormalities or clinically important changes in physical examination
    20. Number of participants that experience abnormalities or clinically important changes in vital signs (body temperature, Respiratory rate, Blood pressure, Heart rate)
    21. Proportion of participants that experience abnormalities or clinically important changes in vital signs (body temperature, Respiratory rate, Blood pressure, Heart rate)
    22. Number of participants that experience abnormalities or clinically important changes in Electrocardiogram (ECG) parameters (PR Interval, QRS, QT interval, QtCF)
    23. Proportion of participants that experience abnormalities or clinically important changes in ECG parameters (PR Interval, QRS, QT interval, QtCF)
    1. Porcentaje de participantes que alcanzan una respuesta SRI(4) con reducción de CS y mantenimiento a ≤ 7,5 mg por día en la Semana 48
    2. Porcentaje de pacientes que alcanzan una respuesta BICLA en la semana 24 y semana 48
    3. Porcentaje de participantes que alcanzan una respuesta SRI(4) sin reducción de CS y mantenimiento a ≤ 7,5 mg por día en la semana 24
    4. Porcentaje de pacientes que alcanzan una respuesta LLDAS en la semana 24 y en la semana 48
    5. Porcentaje de pacientes con una puntuación CLASI-A ≥ 10 en el basal que alcanzan una respuesta CLASI-50, definida como una reducción de ≥ 50% respecto al basal en la puntuación CLASI-A en la semana 24 y en la semana 48
    6. Porcentaje de pacientes con 6 o más articulaciones inflamadas y 6 o más articulaciones sensibles en el basal que alcanzan una reducción ≥ 50% respecto al basal tanto en las articulaciones inflamadas como dolorosas en la semana 24 y en la semana 48
    7. Media del cambio respecto al basal en el recuento de articulaciones inflamadas usando el recuento de 28 articulaciones en la semana 24 y en la semana 48 en pacientes con ≥ 2 articulaciones inflamadas en el basal
    8. Media del cambio respecto al basal en el recuento de articulaciones sensibles usando el recuento de 28 articulaciones en la semana 24 y en la semana 48 en pacientes con ≥ 2 articulaciones sensibles en el basal
    9. Cambio desde el basal en la puntuación PGA de actividad de la enfermedad en la semana 24 y en la semana 48
    10. Porcentaje de pacientes que alcanzan una reducción de CS y mantenimiento a ≤ 7,5 mg por día en la semana 48
    11. Cambio en la actividad de la enfermedad comunicado por el paciente respecto al basal hasta la semana 24 y la semana 48 de acuerdo con el SF-36
    12. Número de pacientes que experimentan AAG
    13. Porcentaje de pacientes que experimentan AAG
    14. Número de pacientes que experimentan AA
    15. Porcentaje de pacientes que experimentan AA
    16. Número de pacientes que experimentan valores anómalos o cambios clínicamente importantes en los resultados de las pruebas de laboratorio (pruebas hematológicas, químicas, pruebas de coagulación, pruebas de análisis de orina, pruebas serológicas)
    17. Proporción de pacientes que experimentan valores anómalos o cambios clínicamente importantes en los resultados de las pruebas de laboratorio (pruebas hematológicas, químicas, pruebas de coagulación, pruebas de análisis de orina, pruebas serológicas)
    18. Número de pacientes que experimentan valores anómalos o cambios clínicamente importantes en la exploración física
    19. Porcentaje de pacientes que experimentan valores anómalos o cambios clínicamente importantes en la exploración física
    20. Número de pacientes que experimentan valores anómalos o cambios clínicamente importantes en las constantes vitales (temperatura corporal, frecuencia respiratoria, presión sanguínea, frecuencia cardiaca)
    21. Porcentaje de pacientes que experimentan valores anómalos o cambios clínicamente importantes en las constantes vitales (temperatura corporal, frecuencia respiratoria, presión sanguínea, frecuencia cardiaca)
    22. Número de pacientes que experimentan valores anómalos o cambios clínicamente importantes en los parámetros del ECG (invervalo PR, QRS, intervalo QT, QtCF)
    23. Porcentaje de pacientes que experimentan valores anómalos o cambios clínicamente importantes en los parámetros del ECG (invervalo PR, QRS, intervalo QT, QtCF)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to 48 Weeks
    2. Up to 48 Weeks
    3. Up to 24 Weeks
    4. Up to 48 Weeks
    5. Up to 48 Weeks
    6. Up to 48 Weeks
    7. Up to 48 Weeks
    8. Up to 48 Weeks
    9. Up to 48 Weeks
    10. Up to 48 Weeks
    11. Up to 48 Weeks
    12. Up to 52 Weeks
    13. Up to 52 Weeks
    14. Up to 52 Weeks
    15. Up to 52 Weeks
    16. Up to 52 Weeks
    17. Up to 52 Weeks
    18. Up to 52 Weeks
    19. Up to 52 Weeks
    20. Up to 52 Weeks
    21. Up to 52 Weeks
    22. Up to 52 Weeks
    23. Up to 52 Weeks
    1. Hasta la semana 48
    2. Hasta la semana 48
    3. Hasta la semana 24
    4. Hasta la semana 48
    5. Hasta la semana 48
    6. Hasta la semana 48
    7. Hasta la semana 48
    8. Hasta la semana 48
    9. Hasta la semana 48
    10. Hasta la semana 48
    11. Hasta la semana 48
    12. Hasta la semana 52
    13. Hasta la semana 52
    14. Hasta la semana 52
    15. Hasta la semana 52
    16. Hasta la semana 52
    17. Hasta la semana 52
    18. Hasta la semana 52
    19. Hasta la semana 52
    20. Hasta la semana 52
    21. Hasta la semana 52
    22. Hasta la semana 52
    23. Hasta la semana 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy 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 No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers analysis.
    Análisis de biomarcadores
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Chile
    Colombia
    France
    Germany
    Ireland
    Japan
    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
    The end of the trial is defined as the last visit or scheduled procedure shown in the Schedule of Activities for the last participant (LVLS).
    El final del ensayo se define como la última visita o procedimiento programado mostrado en el Esquema de Actividades del último participante (LVLS).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days19
    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: 582
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 118
    F.4.2.2In the whole clinical trial 600
    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)
    At the end of the treatment period, BMS will not continue to provide BMS-supplied study intervention to participants/investigators unless BMS chooses to extend the study or provide study intervention via a separate long-term extension study.
    Al final del periodo de tratamiento, BMS no continuará proporcionando el fármaco de estudio suministrado por BMS a los participantes/investigadores a menos que BMS elija extender el estudio o proporcionar la medicación del estudio a través de un estudio de extensión a largo plazo separado.
    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 Decision2021-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-05
    P. End of Trial
    P.End of Trial StatusOngoing
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