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    Summary
    EudraCT Number:2017-001764-37
    Sponsor's Protocol Code Number:GA30066
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-09-18
    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 number2017-001764-37
    A.3Full title of the trial
    A PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
    ESTUDIO DE EXTENSIÓN ABIERTO DE FASE II DE PACIENTES A LOS QUE SE INSCRIBIÓ PREVIAMENTE EN EL ESTUDIO GA30044 PARA EVALUAR LA SEGURIDAD Y LA EFICACIA A LARGO PLAZO DE GDC-0853 EN PACIENTES CON LUPUS ERITEMATOSO SISTÉMICO ACTIVO DE MODERADO A GRAVE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Active Systemic Lupus Erythematosus
    Estudio de extension de pacientes previamente inscritos en el ensayo GA30044 para evaluar la eficacia y seguridad a largo plazo de GDC-0853 en pacientes con Lupus eritematoso sistemico activo de moderado a grave
    A.4.1Sponsor's protocol code numberGA30066
    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 SponsorRoche Farma, S.A por delegación de Genentech, Inc.
    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 supportGenentech Inc. c/o F. Hoffman-La Roche Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34913257300
    B.5.6E-mailspain.start_up_unit@roche.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 nameGDC-0853
    D.3.2Product code RO7010939/F13
    D.3.4Pharmaceutical form 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 yet
    D.3.9.1CAS number 1434048-34-6
    D.3.9.2Current sponsor codeGDC-0853, RO7010939
    D.3.9.3Other descriptive nameGDC-0853 RO7010939
    D.3.9.4EV Substance CodeSUB181260
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Systemic Lupus Erythematosus
    Lupus eritematoso sistemico
    E.1.1.1Medical condition in easily understood language
    Systemic lupus erythematosus (SLE) is an autoimmune disease in which the body's immune system mistakenly attacks healthy tissue
    El lupus eritematoso sistémico (LES) es una enfermedad autoinmune en la cual el sistema inmune del cuerpo ataca por error al tejido sano.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 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
    •To evaluate the long-term safety of GDC-0853 over an extended treatment period of up to 48 weeks
    •Evaluar la seguridad a largo plazo de GDC-0853 durante un periodo de tratamiento extendido de hasta 48 semanas.
    E.2.2Secondary objectives of the trial
    •To evaluate the clinical efficacy of GDC-0853 in combination with standard of care over time
    •To characterize the pharmacokinetics (PK) of GDC-0853 in patients using a population PK approach
    •Evaluar la eficacia clínica de GDC-0853 en combinación con el tratamiento de referencia con el paso del tiempo
    •Caracterizar la farmacocinética de GDC-0853 en los pacientes con un enfoque FC de población
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18−76 years
    - Completion of Study GA30044 up to 48 weeks
    - Acceptable safety and tolerability during Study GA30044 as determined by the investigator
    - Women of childbearing potential must have a negative urine pregnancy test at baseline
    - For women of childbearing potential: agreement to remain abstinent or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 60 days after the last dose of study drug
    - For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm resulting in a failure rate of < 1% per year during the treatment period and for at least 120 days (4 months) after the last dose of study treatment
    -Edad 18-76 años
    -Haber completado el estudio GA30044 hasta las 48 semanas
    -Seguridad y tolerabilidad aceptables durante el estudio GA30044 según lo determine el investigador
    -Las mujeres en edad fértil deben presentar una prueba de embarazo en orina negativa al inicio
    -En las mujeres en edad fértil: Aceptación de mantener la abstinencia sexual o usar un método anticonceptivo con un índice de fallo del < 1 % al año durante el periodo de tratamiento y durante un mínimo de 60 días tras la última dosis del fármaco del estudio.
    -En el caso de los hombres: aceptación de mantener la abstinencia sexual o usar medidas anticonceptivas y aceptar no donar esperma resultando en un índice de fallo del < 1 % al año durante el periodo del tratamiento y durante un mínimo de 120 días (4 meses) tras la última dosis del tratamiento del estudio.
    E.4Principal exclusion criteria
    - Met protocol-defined treatment-stopping criteria during Study GA30044
    - An adverse event in Study GA30044 that required permanent discontinuation of study drug
    - During Study GA30044, treatment with any therapy that is prohibited in this study
    - In the opinion of the investigator, any new (since initially enrolling in the Phase II Study GA30044), significant, uncontrolled comorbidity or new clinical manifestation (related to SLE or not) that 1) requires medications not allowed in this protocol or 2) could put the patient at undue risk from a safety perspective
    - Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of study drug
    - Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the patient’s participation in the study in the opinion of the investigator in consultation with the Medical Monitor
    -Cumplan con alguno de los criterios de interrupción del tratamiento definidos por protocolo durante el estudio GA30044
    -Sufrieran un acontecimiento adverso en el estudio GA30044 que requiriera la interrupción permanente del fármaco del estudio
    -Durante el estudio GA30044, el tratamiento con cualquier tratamiento que esté prohibido en este estudio
    -En opinión del investigador, cualquier comorbilidad nueva, significativa y no controlada (desde la inscripción inicial en el estudio de fase II GA30044) o manifestación clínica nueva (relacionada o no con el LES) que 1) requiera administrar medicamentos no permitidos en este protocolo o 2) pueda poner al paciente en riesgo excesivo desde la perspectiva de la seguridad
    -Embarazada, en período de lactancia o intentando quedarse embarazada durante el estudio o en los 60 días posteriores a la última dosis del fármaco del estudio
    -Cualquier anomalía clínica no controlada clínicamente significativa que pudiera afectar a la seguridad o a la interpretación de los datos del estudio, así como a la participación del paciente en el estudio, a juicio del investigador y en consulta con el Monitor médico
    E.5 End points
    E.5.1Primary end point(s)
    1.The nature, frequency, severity, and timing of adverse events
    2.Changes in vital signs, physical findings, ECGs, and clinical laboratory results during and following GDC 0853 administration
    1. Naturaleza, frecuencia, intensidad y momento de los acontecimientos adversos
    2. Cambios en las constantes vitales, hallazgos físicos, los ECG y los resultados clínicos de laboratorio tras la administración de GDC-0853
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2. Up to 56 weeks
    1-2. Hasta un máximo de 56 semanas
    E.5.2Secondary end point(s)
    1.SLE Responder Index -4 response up to Week 48
    2.Steady-state PK parameters such as area under the concentration–time curve from time 0 to time t (AUC0-t), Ctrough, half-life (t1/2), and apparent clearance (CL/F)
    1. Respuesta SRI-4 hasta la semana 48
    2. Parámetros de FC en estado de equilibrio: ABC0-t, Cmín, t1/2 y CL/F aparente
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Up to Week 48
    2.Baseline (Day 1), Week 24, Week 48, at unscheduled visit, flare visit and early terminate
    1. Hasta la semana 48
    2. Basal (dia 1), semana 24, semana 48, visita no programada, visita flare y terminacion temprana
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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.8.3 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 EEA30
    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
    Bulgaria
    Chile
    Colombia
    Germany
    Korea, Republic of
    Mexico
    Portugal
    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 this study is defined as the date when the last patient, last visit occurs. The end of the study is expected to occur 56 weeks after the last patient is enrolled. The total length of the study, from enrollment of the first patient to the end of the study, is expected to be approximately 3.5 years.
    El fin de este estudio se define como la fecha en la que se produce la última visita del último paciente. Se espera que el fin del estudio se produzca 56 semanas después de inscribir al último paciente. La duración total del estudio, desde la inscripción del primer paciente hasta el fin del estudio se espera que sea de aproximadamente 3,5 años.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 240
    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)
    Currently, the Sponsor (Genentech, a member of the Roche Group) does not have any plans to provide Sponsor study drug GDC-0853 or any other study treatments or interventions to patients who have completed Study GA30066. The Sponsor may evaluate whether to continue providing GDC-0853 in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, available at the following Web site: http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    Actualmente, el promotor (Genentech, miembro del Grupo Roche) no tiene planes para proporcionar la medicación del promotor GDC-0853 ni cualquier tratamiento del estudio o intervencion a los pacientes que hayan completado el ensayo GA30066. El promotor podrá evaluar si continua proporcionando GDC-0853 de acuerdo a la politica global de acceso continuado a fármacos de investigacion disponible en la siguiente página web: http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    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 Decision2017-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-11-18
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