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    Summary
    EudraCT Number:2018-003927-12
    Sponsor's Protocol Code Number:DRI15928
    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:2019-01-22
    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 number2018-003927-12
    A.3Full title of the trial
    A Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis
    Estudio fase 2b de búsqueda de dosis para SAR442168, un inhibidor de la tirosina quinasa de Bruton, en participantes con esclerosis múltiple recurrente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dose-finding study for SAR442168 in relapsing multiple sclerosis
    Estudio de búsqueda de dosis para SAR442168 en esclerosis múltiple recurrente
    A.4.1Sponsor's protocol code numberDRI15928
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1220-0572
    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 SponsorGenzyme Corporation
    B.1.3.4CountryUnited States
    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 supportGenzyme Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointUnidad Estudios Clinicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla 2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 94 00
    B.5.6E-mailes-unidadestudiosclinicos@sanofi.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.3.2Product code SAR442168
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 1971920-73-6
    D.3.9.2Current sponsor codeSAR442168
    D.3.9.3Other descriptive namePRN2246
    D.3.9.4EV Substance CodeSUB195428
    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.3.2Product code SAR442168
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 1971920-73-6
    D.3.9.2Current sponsor codeSAR442168
    D.3.9.3Other descriptive namePRN2246
    D.3.9.4EV Substance CodeSUB195428
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing Multiple Sclerosis
    Esclerosis múltiple recurrente
    E.1.1.1Medical condition in easily understood language
    Relapsing Multiple Sclerosis
    Esclerosis múltiple recurrente
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of SAR442168 in reducing the number of new brain lesions reported in Magnetic Resonance Imaging (MRI)
    Determinar la relación dosis-respuesta de SAR442168 en la reducción del número de lesiones cerebrales activas nuevas
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of SAR442168 on clinical symptoms and imaging measures
    - To evaluate the safety and tolerability of SAR442168
    - Evaluar la eficacia de SAR442168 en la actividad de la enfermedad a partir de los síntomas clínicos y de los resultados de las pruebas de imagen
    - Evaluar la seguridad y la tolerabilidad de SAR442168
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.
    - Participant must have been diagnosed with relapsing multiple sclerosis (RMS) according to the 2017 revision of the McDonald diagnostic criteria.
    - Participant must have at least 1 documented relapse within the previous year, ≥2 documented relapses within the previous 2 years, or ≥1 active Gadolinium (Gd)-enhancing brain lesion on an magnetic resonance imaging (MRI) scan in the past 6 months and prior to screening.
    - A female participant must use a double contraception method including a highly effective method of birth control, except if she has undergone sterilization at least 3 months earlier or is postmenopausal.
    - Male participants, whose partners are of childbearing potential (including breastfeeding women), must accept to use, during sexual intercourse, a double contraceptive method according to the following algorithm: (condom) plus (intrauterine device or hormonal contraceptive) from inclusion up to 3 months after the last dose.
    - Male participants whose partners are pregnant must use, during sexual intercourse, a condom from inclusion up to 3 months after the last dose.
    - Male participants must have agreed not to donate sperm from the inclusion up to 3 months after the last dose.
    - Participant must have given written informed consent prior to undertaking any study-related procedure.
    - El participante debe tener entre 18 y 55 años de edad, inclusive, en el momento de firmar el consentimiento informado.
    - El participante debe haber sido diagnosticado con esclerosis múltiple (RMS) recurrente de acuerdo con la revisión de 2017 de los criterios diagnósticos de McDonald.
    - El participante debe tener al menos 1 recaída documentada dentro del año anterior, 2 ó más recaídas documentadas dentro de los 2 años anteriores, o 1 ó más lesiones cerebrales activas realzadas con gadolinio (Gd) en una imagen de Resonancia Magnética (MRI)en los últimos 6 meses y antes de la selección.
    - Una participante femenina debe usar un método anticonceptivo doble que incluya un método anticonceptivo altamente eficaz, excepto si se ha sometido a una esterilización al menos 3 meses antes o es posmenopáusica.
    - Los participantes masculinos, cuyas parejas son potencialmente fértiles (incluidas las mujeres que amamantan), deben aceptar utilizar, durante las relaciones sexuales, un método anticonceptivo doble de acuerdo con el siguiente algoritmo: (condón) más (dispositivo intrauterino o anticonceptivo hormonal) desde la inclusión hasta 3 meses después de la última dosis.
    - Los participantes masculinos cuyas parejas están embarazadas deben usar, durante las relaciones sexuales, un condón desde su inclusión hasta 3 meses después de la última dosis.
    - Los participantes masculinos deben haber acordado no donar esperma desde la inclusión hasta 3 meses después de la última dosis.
    - El participante debe haber dado su consentimiento informado por escrito antes de realizar cualquier procedimiento relacionado con el estudio.
    E.4Principal exclusion criteria
    - The participant has been diagnosed with primary progressive multiple sclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria or with non relapsing secondary progressive multiple sclerosis (SPMS).
    - Requirement for concomitant treatment that could bias the primary evaluation.
    - Contraindication for MRI.
    - Contraindications to use MRI Gd contrast-enhancing preparations.
    - History of infection with the human immunodeficiency virus (HIV).
    - History of active or latent tuberculosis.
    - Any other active infections that would adversely affect participation or investigational medicinal product (IMP) administration in this study, as judged by the Investigator.
    - Presence of any screening laboratory or ECG values outside normal limits that are considered in the Investigator’s judgment to be clinically significant.
    - Presence of liver injury.
    - At screening, the participant is positive for hepatitis B surface antigen and/or hepatitis B core antibody and/or is positive for hepatitis C antibody.
    - Bleeding disorder or known platelet dysfunction at any time prior to screening visit.
    - Participant has received any live (attenuated) vaccine (including but not limited to varicella zoster, oral polio, and nasal influenza) within 2 months before first treatment visit.
    - Participant is receiving strong inducers or inhibitors of CYP3A or CYP2C8 hepatic enzymes.
    - Participant is receiving anticoagulant/antiplatelet therapies.
    - Participant has taken other investigational drugs within 3 months or 5 half lives, whichever is longer, before screening visit.
    - Participant has an Expanded Disability Status Scale (EDSS) score >5.5 at screening visit.
    - Participant has had a relapse in the 30 days prior to randomization.
    - Participant is pregnant or a breastfeeding woman.
    - History or presence of significant other concomitant illness.
    - The participant has received medications/treatments for MS within a specified time frame.
    - El participante ha sido diagnosticado con esclerosis múltiple progresiva primaria (PPMS) de acuerdo con la revisión de 2017 de los criterios de diagnóstico de McDonald o con esclerosis múltiple progresiva secundaria no recurrente (SPMS).
    - Cualquier tratamiento concomitante que podría sesgar la evaluación primaria.
    - Contraindicación para la resonancia magnética.
    - Contraindicaciones para el uso de preparaciones de contraste de MRI Gd.
    - Historial de infección con el virus de la inmunodeficiencia humana (VIH).
    - Antecedentes de tuberculosis activa o latente.
    - Cualquier otra infección activa que pudiera afectar de manera adversa la participación o la administración de medicamentos en investigación (IMP) en este estudio, a juicio del investigador.
    - Presencia de cualquier valor de laboratorio o de ECG fuera de los límites normales que se consideren clínicamente significativos.
    - Presencia de lesión hepática.
    - En la selección, el participante que es positivo para el antígeno de superficie de la hepatitis B y / o el anticuerpo del núcleo de la hepatitis B y / o es positivo para el anticuerpo de la hepatitis C.
    - Trastorno de sangrado o disfunción plaquetaria conocida en cualquier momento antes de la visita de selección.
    - El participante ha recibido cualquier vacuna viva (atenuada) (que incluye, entre otras, varicela zóster, polio oral y gripe nasal) dentro de los 2 meses anteriores a la primera visita de tratamiento.
    - El participante está recibiendo inductores o inhibidores fuertes de las enzimas hepáticas CYP3A o CYP2C8.
    - El participante está recibiendo terapias anticoagulantes / antiplaquetarias.
    - El participante ha tomado otros medicamentos en investigación dentro de los 3 meses o 5 vidas medias, lo que sea más largo, antes de la visita de selección.
    - El participante tiene una puntuación de Escala de estado de discapacidad expandida (EDSS) superior a 5.5 en la visita de selección.
    - El participante tuvo una recaída en los 30 días previos a la aleatorización.
    - La participante está embarazada o amamantando.
    - Historia o presencia de otras enfermedades concomitantes significativas.
    - El participante ha recibido medicamentos / tratamientos para la EM dentro de un período de tiempo especificado.
    E.5 End points
    E.5.1Primary end point(s)
    Number of new Gd-enhancing T1 hyperintense lesions : Number of new Gd-enhancing T1 hyperintense lesions at the end of 12 weeks of SAR442168 treatment as detected by brain MRI
    Número de nuevas lesiones hiperintensas en T1 realzadas con Gd después de 12 semanas de tratamiento con SAR442168 confirmadas mediante RMN cerebral
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12 for Arms 1-4, Week 4 and Week 16 for Arms 5-8
    Semana 12 para los brazos 1-4, semana 4 y semana 16 para los brazos 5-8
    E.5.2Secondary end point(s)
    1 - Number of new or enlarging T2 lesions : Number of new or enlarging T2 lesions at the end of 12 weeks of SAR442168 treatment
    2 - Total number of Gd-enhancing T1 hyperintense lesions : Total number of Gd-enhancing T1-hyperintense lesions at the end of 12 weeks of SAR442168 treatment
    3 - Adverse events : Number (n) and percentage (%) of participants experiencing an adverse event (AE)/Serious
    Adverse Event (SAE) or potentially clinically significant abnormalities in laboratory tests, electrocardiogram (ECG), or vital signs
    1. Número de nuevas lesiones en T2 o que hayan aumentado de tamaño después de 12 semanas de tratamiento con SAR442168
    2. Número de nuevas lesiones hiperintensas en T1 realzadas con Gd después de 12 semanas de tratamiento con SAR442168
    3. Acontecimientos adversos: número (n) y porcentaje (%) de participantes que experimentaron un acontecimiento adverso (AA) / grave (AAG) o anomalías clínicamente significativas en las pruebas de laboratorio, electrocardiograma (ECG) o constantes vitales durante el periodo del estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2 : Week 12 for Arms 1-4, Week 4 and Week 16 for Arms 5-8
    3 : From baseline to the end of study (approximately 20 weeks)
    1, 2: Semana 12 para los Brazos 1-4, Semana 4 y Semana 16 para los Brazos 5-8
    3: desde el inicio hasta el final del estudio (aproximadamente 20 semanas)
    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 No
    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 Yes
    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 trial8
    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 EEA27
    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
    Czech Republic
    Estonia
    France
    Netherlands
    Norway
    Russian Federation
    Slovakia
    Spain
    Sweden
    Ukraine
    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
    Última visita del último paciente
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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: 160
    F.1.3Elderly (>=65 years) No
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 91
    F.4.2.2In the whole clinical trial 160
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Participants completing the double-blind treatment period will be given the option to receive treatment with SAR442168 in a long term safety follow-up study.
    A los participantes que completen el período de tratamiento doble ciego se les dará la opción de recibir tratamiento con SAR442168 en un estudio de seguimiento de seguridad a largo plazo.
    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 Decision2019-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-02
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