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    Summary
    EudraCT Number:2011-003409-36
    Sponsor's Protocol Code Number:GA27927
    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:2011-11-18
    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 number2011-003409-36
    A.3Full title of the trial
    A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of rhuMAb Beta7 in Patients with Moderate to Severe Ulcerative Colitis
    ESTUDIO DE EXTENSIÓN, FASE II Y ABIERTO PARA EVALUAR LA SEGURIDAD A LARGO PLAZO DE rhuMAb BETA7 EN PACIENTES CON
    COLITIS ULCEROSA MODERADA O GRAVE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the long term safety of rhuMab Beta7 in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease)
    Estudio para evaluar la seguridad de rhuMab Beta7 a largo plazo en pacientes con colitis ulcerosa moderada o grave (una forma de enfermedad inflamatoria del intestino)
    A.4.1Sponsor's protocol code numberGA27927
    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 SponsorGenentech, 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. Hoffmann-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 organisationGenentech Inc. c/o F. 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----
    B.5.5Fax number----
    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 namerhuMAb Beta7
    D.3.2Product code PRO145223 (RO5490261)
    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 INNn.a.
    D.3.9.2Current sponsor codePRO145223 (RO5490261)
    D.3.9.3Other descriptive namerhuMAb Beta7
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 typerecombinant humanized IgG1 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
    Ulcerative colitis
    colitis ulcerosa
    E.1.1.1Medical condition in easily understood language
    A form of inflammatory bowel disease
    Un tipo de enfermedad intestinal inflamatoria
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    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
    To assess the long-term safety and tolerability of rhuMAb Beta7, as measured by adverse events, immunogenicity and safety laboratory parameters, over an extended 2 year treatment period
    Evaluar la seguridad y la tolerabilidad a largo plazo de rhuMAb Beta7, en base a acontecimientos adversos, inmunogenicidad y parámetros de seguridad de laboratorio durante un período de
    tratamiento ampliado de 2 años
    E.2.2Secondary objectives of the trial
    To obtain long-term data on the effectiveness, immunogenicity and exposure of rhMAb Beta7
    Obtener datos a largo plazo sobre la eficacia, la inmunogenicidad y la exposición de rhuMAb Beta7
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? All patients (placebo or active) who were previously enrolled in the Phase II study (ABS4986g) and who have completed this study or who fulfill any of the criteria specified in the protocol regarding clinical response.
    ? Ability and willingness to provide written informed consent and comply with the requirements of the OLE protocol
    ? Males and females with reproductive potential must be willing to use a highly effective method of contraception (e.g., hormonal contraceptive [oral or patch], vaginal ring, intrauterine device, physical barrier, or vasectomized partner) from study start to a minimum of 4 months (approximately 5 half lives)
    ? Todos los pacientes (del grupo placebo o de tratamiento activo) que fueron incluidos previamente en el estudio de fase II (ABS4986g) y que cumplan alguno de los criterios especificados en el protocolo con relación a la respuesta clínica.
    ? Disposición y capacidad para otorgar el consentimiento informado por escrito y cumplir los requisitos del protocolo de la ERA.
    ? Los varones y las mujeres en edad fértil deben estar dispuestos a utilizar un método anticonceptivo muy eficaz (por ejemplo, anticonceptivos hormonales [orales o en parche], anillo vaginal, dispositivo intrauterino, barrera física o pareja vasectomizada) desde el comienzo del estudio y durante un mínimo de 4 meses (aproximadamente 5 semividas) después de la última dosis.
    E.4Principal exclusion criteria
    ? Pregnancy or lactation
    ? Any new malignancy within the past 6 months
    ? Any new, significant, uncontrolled co morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or GI disorders (since enrolling in the Phase II study [ABS4986g])
    ? Any new clinically significant signs or symptoms of infection as judged by the investigator
    ? Any abnormal lab values recorded at the last visit completed in the Phase II study (ABS4986g) as follows:
    Moderate to severe anemia (hemoglobin less than 9 g/dL)
    Impaired renal function (serum creatinine greater than 1.5 x upper limit of normal [ULN])
    Impaired hepatic function in the absence of a diagnosis of primary sclerosing cholangitis (serum transaminases greater than 2.5 x ULN, alkaline phosphatase greater than 2.5 x ULN, total bilirubin greater than 1.5 x ULN, or abnormalities in synthetic liver function tests judged by the investigator to be clinically significant). If the patient has a diagnosis of primary sclerosing cholangitis, serum transaminases grater than 3 x ULN, alkaline phosphatase greater than 3 x ULN, total bilirubin greater than 2.5 x ULN, or abnormalities in synthetic liver function tests judged by the investigator to be clinically significant.
    Thrombocytopenia (platelet count less than 75,000/microL)
    Neutropenia (absolute neutrophil count less than 1500/microL)
    Lymphopenia (absolute lymphocyte count less than 500/microL)
    Embarazo o lactancia
    ? Cualquier neoplasia maligna nueva en los últimos 6 meses
    ? Cualquier enfermedad concomitante nueva (desde la inclusión en el estudio de fase II [ABS4986g]) importante y no controlada, como trastornos neurológicos (por ejemplo, anomalías en el Mini-Mental Scale Examination [MMSE] y en la evaluación de la LMP), cardíacos, pulmonares, renales, hepáticos, endocrinos o digestivos
    ? Cualquier signo o síntoma nuevo de infección clínicamente significativo, según el criterio del investigador
    ? Cualquier valor analítico anormal registrado en la última visita completada en el estudio de fase II (ABS4986g), es decir:
    ? Anemia moderada o grave (hemoglobina < 9 g/dl)
    ? Insuficiencia renal (creatinina sérica > 1,5 veces el límite superior de la normalidad [LSN])
    ? Insuficiencia hepática en ausencia de un diagnóstico de colangitis esclerosante primaria (transaminasas séricas > 2,5 veces el LSN, fosfatasa alcalina > 2,5 veces el LSN, bilirrubina total > 1,5 veces el LSN o anomalías en las pruebas de función hepática que el investigador considere con importancia clínica). Si el paciente tiene un diagnóstico de colangitis esclerosante primaria, transaminasas séricas > 3 veces el LSN, fosfatasa alcalina > 3 veces el LSN, bilirrubina total > 2,5 veces el LSN o anomalías en las pruebas de función hepática que el investigador considere con importancia clínica.
    ? Trombocitopenia (recuento de plaquetas < 75.000/µl).
    ? Neutropenia (recuento absoluto de neutrófilos < 1.500/µl).
    ? Linfopenia (recuento absoluto de linfocitos < 500/µl).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are safety endpoints, including the adverse event incidence, serious adverse event incidence, changes in safety laboratory tests, analytes (ie, serum chemistry), physical examination and vital signs, and specific evaluations for immunogenicity, allergic reaction, injection site reactions and progressive multifocal leukoencephalopathy (PML).
    Las variables principales son variables de seguridad, incluyendo Incidencia de AA y AAG, cambios en parámetros de seguridad de laboratorio, analos (bioquímica seríca9, examen físico, constantes vitales, y evaluaciones específicas para inmunogenicidad, reacciones alérgicas, reacciones en el lugar de inyección y leucoencefalopatía multifocal progresiva (LMP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    E.5.2Secondary end point(s)
    N/A
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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 No
    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 concerned2
    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
    Australia
    Belgium
    Canada
    Czech Republic
    Germany
    Hungary
    Israel
    New Zealand
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 60
    F.4.2.2In the whole clinical trial 120
    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)
    The patient may revert back to standard of care with their physician.
    El paciente puede volver al cuidado estandar 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 Decision2011-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-08
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