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    Summary
    EudraCT Number:2014-003855-76
    Sponsor's Protocol Code Number:GA29145
    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:2015-03-27
    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 number2014-003855-76
    A.3Full title of the trial
    AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN?S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144
    ESTUDIO ABIERTO DE EXTENSIÓN Y SUPERVISIÓN DE LA SEGURIDAD DE PACIENTES CON ENFERMEDAD DE CROHN CON ACTIVIDAD DE MODERADA A GRAVE PREVIAMENTE INSCRITOS EN EL PROTOCOLO DE FASE III CON ETROLIZUMAB, GA29144
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease
    Estudio abierto de extensión para valorar la seguridad y efectividad del tratamiento con etrolizumba en pacientes con enfermedad de Crohn con actividad de moderada a grave
    A.4.1Sponsor's protocol code numberGA29145
    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. en nombre de F. Hoffmann-La Roche Ltd
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    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 number34913257300
    B.5.6E-mailglobal.rochegenentechtrials@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 nameEtrolizumab
    D.3.2Product code Ro 549-0261/F04-02
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNEtrolizumab
    D.3.9.1CAS number 1044758-60-2
    D.3.9.2Current sponsor codeRO5490261
    D.3.9.3Other descriptive nameETROLIZUMAB
    D.3.9.4EV Substance CodeSUB75320
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number105
    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 Yes
    D.3.11.13.1Other medicinal product typeHumanized monoclonal antibody
    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
    Crohn`s Disease
    Enfermedad de Crohn
    E.1.1.1Medical condition in easily understood language
    A form of inflammatory bowel disease
    Un tipo de enfermedad inflamatoria intestinal
    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 17.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this open-label extension?safety monitoring (OLE-SM) study are as follows:
    Part 1 (Open-Label Extension; OLE)
    ? To assess the long-term safety and efficacy of etrolizumab in patients eligible for Part 1 (OLE)
    Part 2 (Safety Monitoring; SM)
    ? Progressive multifocal leukoencephalopathy (PML) safety monitoring in patients who have stopped study treatment

    Safety Objectives
    The other safety objectives for this study are as follows:
    Part 1 (OLE)
    ? To evaluate the incidence, rate per subject-year, and severity of infection-related adverse events
    ? To evaluate the incidence and rate per subject-year of malignancies
    ? To evaluate the incidence and severity of hypersensitivity reactions
    ? To evaluate the incidence and the clinical significance of anti-therapeutic antibodies (ATAs)
    Los objetivos de este estudio abierto de extensión y supervisión de la seguridad (OLE-SM) son los siguientes:
    Parte 1 (Estudio abierto de extensión; OLE)
    ? Evaluar la seguridad y la eficacia a largo plazo de etrolizumab en pacientes aptos para la parte 1 (OLE)
    Parte 2 (Supervisión de Seguridad; SM)
    ? Supervisión de la seguridad de la leucoencefalopatía multifocal progresiva LMP en pacientes que han suspendido el tratamiento del estudio
    Objetivos de Seguridad
    Parte 1 (OLE)
    ? Evaluar la incidencia, la tasa por año-sujeto y la intensidad de los acontecimientos adversos relacionados con las infecciones
    ? Evaluar la incidencia y la tasa por año-sujeto de tumores malignos
    ? Evaluar la incidencia e intensidad de las reacciones de hipersensibilidad
    ? Evaluar la incidencia e importancia clínica de los anticuerpos antiterapéuticos (AAT)
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part 1 Open-label Extension:
    -Patients previously enrolled in etrolizumab Phase III study GA29144 who meet the eligibility criteria for open-label etrolizumab as described in the protocol

    Part 2 Safety Monitoring:
    -Patients who participated in etrolizumab Phase III study GA29144 and are not eligible or choose not to enter Part 1
    -Patients who transfer from Part 1
    -Completion of the 12-week safety follow-up period prior to entering
    Parte 1 (Estudio abierto de extensión; OLE)
    Pacientes que previamente estuvieron inscritos en el estudio de etrolizumab fase III GA29144 y que cumplieron los criterios de eligibilidad para el estudio abierto de extensión de etrolizumab tal y como se describe en el protocolo.
    Parte 2 Supervisión de Seguridad; SM)
    Pacientes que participaron en el estudio de etrolizumab fase III GA29144 y que no son aptos u optaron por no participar en la parte 1.
    Pacientes que participaron en la parte 1 (OLE) de este protocolo
    Pacientes que han completado el seguimiento de la seguridad de 12 semanas antes de participar
    E.4Principal exclusion criteria
    Part 1 Open-label Extension:
    -Any new, significant, uncontrolled condition

    Part 2 Safety Monitoring:
    -No exclusion criteria
    Parte 1 (Estudio abierto de extensión)
    - Cualquier comorbilidad nueva, significativa y no controlada
    Parte 2 Supervisión de Seguridad)
    - No hay criterios de exclusión.
    E.5 End points
    E.5.1Primary end point(s)
    The efficacy outcome measures:
    ? CDAI remission assessed at 12-week intervals during Part 1 (OLE)
    ? PRO2 remission assessed at 12-week intervals during Part 1 (OLE)

    Safety Outcome Measures
    Part 1 (OLE)
    ? Incidence and severity of adverse events
    ? Incidence of serious adverse events
    ? Incidence, rate per subject-year, and severity of infection-related adverse events
    ? Incidence of serious infection-related adverse events
    ? Incidence and severity of injection-site reactions
    ? Incidence of adverse events leading to etrolizumab discontinuation
    ? Incidence of laboratory abnormalities
    ? Incidence and rate per subject-year of malignancies
    ? Incidence of ATAs to etrolizumab
    ? Incidence and severity of hypersensitivity reaction events

    Part 2 (SM)
    ? Incidence of suspected or confirmed PML events
    Los criterios de valoración de la eficacia son:
    ? Remisión del CDAI evaluado a intervalos de 12 semanas durante la parte 1 (OLE)
    ? Remisión de RCP2 evaluados a intervalos de 12 semanas durante la parte 1 (OLE)
    Criterios de valoración de la seguridad
    Parte 1 (OLE)
    ? Incidencia e intensidad de los acontecimientos adversos
    ? Incidencia de los acontecimientos adversos graves
    ? Incidencia, tasa por año-sujeto e intensidad de los acontecimientos adversos relacionados con las infecciones
    ? Incidencia de los acontecimientos adversos relacionados con las infecciones graves
    ? Incidencia e intensidad de las reacciones en el lugar de la inyección
    ? Incidencia de los acontecimientos adversos que llevaron a la suspensión de la administración de etrolizumab
    ? Incidencia de anomalías analíticas
    ? Incidencia y tasa de tumores malignos por año-sujeto
    ? Incidencia de AAT contra etrolizumab
    ? Incidencia e intensidad de los episodios de reacción de hipersensibilidad
    Parte 2 (SM)
    ? Incidencia de los acontecimientos sospechosos o confirmados de LMP
    E.5.1.1Timepoint(s) of evaluation of this end point
    ? CDAI remission assessed at 12-week
    ? PRO2 remission assessed at 12-week

    The CDAI and PRO2 scores will be calculated, and the APQ (Abdominal Pain Questionnaire) will be completed every 12 weeks and at Study Completion
    ? Remisión del CDAI evaluado a la semana 12
    ? Remisión de RCP2 evaluados a la semana 12
    Se calcularán las puntuaciones de CDAI y RCP2, y se completará el CDA cada 12 semanas y en la finalización del estudio.
    E.5.2Secondary end point(s)
    Not applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    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 No
    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) No
    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 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 Yes
    E.8.1.7.1Other trial design description
    Extensión y seguridad
    Extension and safety
    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 trial1
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA200
    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
    Canada
    Israel
    Korea, Republic of
    Mexico
    New Zealand
    Russian Federation
    Serbia
    South Africa
    Switzerland
    Turkey
    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
    The end of the study is defined as the date when the last patient completes the 92-week PML safety?monitoring period.
    El final del estudio se define como la fecha en la que el último paciente completa el período de supervisión de la seguridad de la LMP de 92 semanas.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    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: 1200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 565
    F.4.2.2In the whole clinical trial 1250
    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)
    Patients will not receive any etrolizumab treatment from the study sponsor after the end of the study. Patients should receive standard of care treatment or treatments that meet the needs of the patient as prescribed by their physician.
    Los pacientes no recibirán ningún tratamiento con etrolizumab por parte del promotor del estudio tras la finalización del estudio. Los pacientes recibirán el tratamiento o tratamientos estándares que satisfagan las necesidades del paciente de acuerdo a la prescripción de su médico.
    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 Decision2015-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-10-09
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