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    Summary
    EudraCT Number:2014-002184-14
    Sponsor's Protocol Code Number:IM128-027
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-22
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-002184-14
    A.3Full title of the trial
    A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus
    Estudio Fase 2, multicéntrico, aleatorizado, doble ciego, controlado con placebo para evaluar la seguridad y eficacia de BMS-931699 frente a placebo sobre una base limitada de tratamiento estándar, en sujetos con lupus eritematoso sistémico activo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus
    Estudio de Seguridad y Eficacia de un biológico para tratar el Lupus Eritematoso Sistémico
    A.4.1Sponsor's protocol code numberIM128-027
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1161-2109
    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 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.5.4Telephone number900 150 160
    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 nameAnti-CD28dab
    D.3.2Product code BMS-931699
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnti-CD28dAb
    D.3.9.1CAS number 1421830-13-8
    D.3.9.2Current sponsor codeBMS-931699
    D.3.9.3Other descriptive nameAnti-CD28dAb
    D.3.9.4EV Substance CodeSUB168198
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous 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
    Active Systemic Lupus Erythematosus
    Lupus Eritematoso Sistémico activo
    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 17.1
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythomatosus in male and female adults. Patients who qualify will be randomized to either active BMS-931699 or placebo for up to 24 weeks. Disease activity and safety will be assessed over the course of the study through laboratory values, various rating scales accepted in systemic lupus erythomatosus studies and patient self reporting.
    Estudio para evaluar la seguridad y eficacia de un biológico novel en el tratamiento de lupus eritematoso sistémico en adultos masculinos y femeninos. Los pacientes cualificados serán aleatorizados tanto al principio acitvo BMS-931699 como a placebo durante más de 24 semanas. La actividad de enfermedad y la seguridad serán evaluadas sobre el curso del estudio mediante valores de laboratorio, varias escalas de puntuación aceptadas en estudios en lupus eritematoso sistémico e informes del propio paciente.
    E.2.2Secondary objectives of the trial
    - proportion of subjects who demonstrate an improvement in their SLE Responder Index assessments
    - proportion of subjects who improve their scores of disease activity
    - change in the use of other medications
    - Proporción de pacientes que demuestran una mejoría en sus Evaluaciones del Indice respuesta en LES
    - Proporción de pacientes que mejoran sus puntuaciones de actividad de la enfermedad
    - Cambio en el uso de otros medicamentos
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenetics Blood Sample Amendment -Number 1 dated 20-Aug-14
    The objective of this Amendment is to permit the collection and storage of blood samples for use
    in future exploratory pharmacogenetic research. Bristol-Myers Squibb will use DNA obtained
    from the blood sample and health information collected from the main clinical trial, IM128027 to
    study the association between genetic variation and drug response.
    Enmienda de Farmacogenética para la recogida de Muestras de sangre - Número 1 de fecha 20-Ago-14
    El objeto de esta enmienda es permitir la recogida y almacenamiento de muestras de sangre para su uso en futura investigación farmacogenética exploratoria. Bristol-Myers Squibb utilizará ADN obtenido de muestras de sangre e información sobre salud extraída del estudio clínico principal , IM1208-027 para estudiar la asociación entre variación genética y respuesta a la medicación.
    E.3Principal inclusion criteria
    Male or female aged between 18 to 70 (included)
    Diagnosed with active systemic lupus erythomatosus by a doctor
    Disease must be in patient?s joints or on the skin at a minimum
    Taking other medications is allowed but some are excluded
    Hombre o mujeres de edades comprendidas entre 18 y 70 años (inclusive)
    Con diagnóstico médico de lupus eritematoso sistémico activo
    La enfermedad debe estar en las articulaciones del paciente o en la piel como mínimo
    Se permite la toma de otros medicamentos pero algunos de ellos están excluidos
    E.4Principal exclusion criteria
    Diagnosed with active lupus nephritis, multiple sclerosis or rheumatoid arthritis
    Diagnosed with active tuberculosis or an ongoing infection with a bacteria or a virus
    Diagnóstico de nefritis lúpica activa, esclerosis múltiple o artritis reumatoide
    Diagnóstico de tuberculosis activa o infección bacteriana o vírica en curso
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects who achieve a BICLA response (BICLA response rate) at Day 169.
    Proporción de pacientes que alcanzan la respuesta BICLA (tasa de respuesta BICLA) en el Día 169.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint will be assessed at Day 169.
    El criterio primario se evaluará en el Día 169.
    E.5.2Secondary end point(s)
    - proportion of subjects who demonstrate an improvement in their SLE Responder Index assessments
    - proportion of subjects who improve their scores of disease activity
    - change in the use of other medications
    - Proporción de pacientes que demuestran una mejoría en sus Evaluaciones del Indice respuesta en LES
    - Proporción de pacientes que mejoran sus puntuaciones de actividad de la enfermedad
    - Cambio en el uso de otros medicamentos
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be assessed at Day 85 and Day 169.
    Los criterios secundarios se evaluarán en el Día 85 y Día 169.
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other 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 trial5
    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 concerned3
    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
    Argentina
    Brazil
    Canada
    Chile
    Colombia
    France
    Germany
    Hungary
    Italy
    Korea, Republic of
    Mexico
    Poland
    Puerto Rico
    Romania
    South Africa
    Spain
    Taiwan
    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
    LPLV
    Último paciente Última visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days14
    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: 280
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 350
    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 conclusion of the study, subjects who continue to demonstrate clinical benefit will be eligible to receive BMS supplied study drug. Study drug may be provided via an extension of the study, a rollover study requiring approval by responsible health authority and ethics committee or through another mechanism at the discretion of BMS. BMS reserves the right to terminate access to BMS supplied study drug if any of the following occur (please see Protocol, Section 3.2)
    Conclusión:los pacientes que continúan demostrando beneficio clínico serán elegibles para recibir medicamento en estudio suministrado por BMS.El medicamento en estudio puede ser suministrado por una extensión del mismo, ampliación del estudio que requiere aprobación por la autoridad sanitaria y el comité ético, o a través de otro mecanismo, a discreción de BMS. BMS se reserva el derecho de finalizar el acceso a dicho suministro si se dieran algunas de las siguientes (ver Protocolo, sección 3.2)
    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 Decision2014-12-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-26
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    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.

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