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    Summary
    EudraCT Number:2013-003554-25
    Sponsor's Protocol Code Number:20090406
    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:2014-02-07
    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 number2013-003554-25
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects with Psoriatic Arthritis: AMVISION-1
    Estudio de fase 3, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia, la seguridad y los efectos sobre la progresión radiográfica de brodalumab en sujetos con artritis psoriásica: AMVISION-1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Brodalumab in Subjects with Psoriatic Arthritis
    Brodalumab en sujetos con artritis psoriásica
    A.3.2Name or abbreviated title of the trial where available
    AMVISION-1
    A.4.1Sponsor's protocol code number20090406
    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 SponsorAmgen 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 supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info - Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6300
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number900850153
    B.5.5Fax numberN/A
    B.5.6E-mailMedinfoInternational@amgen.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 namebrodalumab (140 mg/ml)
    D.3.2Product code AMG 827
    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 INNbrodalumab
    D.3.9.1CAS number 1174395-19-7
    D.3.9.2Current sponsor codeAMG 827
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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.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.3.1Product namebrodalumab (70mg/0.5ml)
    D.3.2Product code AMG 827
    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 INNbrodalumab
    D.3.9.1CAS number 1174395-19-7
    D.3.9.2Current sponsor codeAMG 827
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    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
    Psoriatic Arthritis
    artritis psoriásica
    E.1.1.1Medical condition in easily understood language
    Psoriatic Arthritis
    artritis psoriásica
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 100000004859
    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 efficacy of brodalumab, (210 mg every 2 weeks (Q2W); and 140 mg Q2W) compared to placebo, in subjects with psoriatic arthritis, as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 20 response at week 16.
    Evaluar la eficacia de brodalumab (210 mg cada 2 semanas [Q2W] y 140 mg Q2W) en comparación con placebo, en sujetos con artritis psoriásica, valorada mediante la proporción de sujetos que alcanzan una respuesta del American College of Rheumatology (ACR) 20 en la semana 16.
    E.2.2Secondary objectives of the trial
    Key Secondary Objectives:
    To evaluate the efficacy of brodalumab compared to placebo on the following:
    ? Psoriasis Area and Severity Index (PASI) 75 at week 16
    ? Van der Heijde modified Total Sharp score (mTSS) at week 24
    Evaluar la eficacia de brodalumab en comparación con placebo en lo siguiente: Índice de intensidad y gravedad de la psoriasis (PASI) 75 en la semana 16, y la puntuación total del índice de Sharp/Van der Heijde modificado (mTSS) en la semana 24.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    -Pharmacokinetic substudy: To characterize the pharmacokinetics (PK) profile of brodalumab.

    -Pharmacogenetic substudy: These optional pharmacogenetic analyses focus on genetic variations to evaluate their possible correlation to the disease and/or responsiveness to the therapies used in this study. The goals of the optional studies include the use of genetic markers to help in the investigation of inflammatory disease and/or to identify subjects who may have a positive or negative response to brodalumab.
    -Biomarkers substudy: These investigations may be useful in developing markers to identify disease subtypes, guide therapy, and/or predict disease progression. In addition to testing the safety and effectiveness of brodalumab in this study, Amgen may attempt to develop blood and/or tissue test(s) designed to identify subjects most likely to respond positively or negatively to brodalumab. Biomarker development may be pursued by use of advanced biochemical analyses, such as proteomic methods or ribonucleic acid transcript profiling
    -Subestudio farmacocinético: caracterizar el perfil farmacocinético (PK) de brodalumab.

    -Subestudio farmacogenético: Estos análisis farmacogenéticos opcionales se centran en las variaciones genéticas para evaluar su posible correlación con la enfermedad y/o la sensibilidad a los tratamientos utilizados en este estudio. Los objetivos de los estudios opcionales incluyen el uso de marcadores genéticos para ayudar en la investigación de la enfermedad inflamatoria y/o para identificar a los sujetos que pueden responder de forma positiva o negativa a brodalumab.

    -Subestudio de biomarcadores: Estas investigaciones pueden ser útiles para el desarrollo de marcadores que permitan identificar subtipos de la enfermedad, guiar el tratamiento y/o predecir la progresión de la enfermedad.
    Además de estudiar la seguridad y la eficacia de brodalumab en este estudio, Amgen podría intentar realizar análisis de sangre y/o tumorales diseñados para identificar aquellos sujetos que tienen una mayor probabilidad de responder de forma positiva o negativa a brodalumab. El desarrollo de esos biomarcadores puede realizarse con análisis bioquímicos avanzados, como los métodos de obtención de perfiles de transcripción del ácido ribonucleico y/o proteómicos.
    E.3Principal inclusion criteria
    - Subject has provided informed consent
    - Subject is ? 18 years of age at time of screening
    - Subject has had a diagnosis of psoriatic arthritis for at least 6 months and currently meets the CASPAR criteria
    - Subject has ? 3 tender and ? 3 swollen joints
    - Subject has a history of intolerance or inadequate response to NSAIDs and/or DMARDs for psoriatic arthritis
    El sujeto ha proporcionado el consentimiento informado antes de iniciar
    cualquierprocedimiento/actividad específico del estudio.
    El sujeto tiene ? 18 años en el momento de la selección.
    El sujeto ha recibido un diagnóstico de artritis psoriásica durante como mínimo 6 meses y en la actualidad cumple los criterios CASPAR.
    El sujeto tiene ? 3 articulaciones dolorosas y ? 3 articulaciones inflamadas (excluyendo las articulaciones interfalángicas distales como parte de un recuento de articulaciones de 66/68) en la selección y en el nivel basal.
    El sujeto tiene como mínimo una erosión en las manos o los pies (evaluación centralizada) o PCR ? 1,0 mg/dL.
    El sujeto tiene una lesión cutánea psoriásica activa (como mínimo una placa psoriásica de aproximadamente 2 cm o más de diámetro).
    El sujeto tiene antecedentes de intolerancia o respuesta inadecuada a los AINE o FAME para la artritis psoriásica.
    Para los sujetos que reciben AINE (incluido el uso según sea necesario [PRN]): el sujeto debe estar tratado con una dosis estable durante ? 4 semanas antes del inicio del producto en investigación.
    Para los sujetos que reciben metotrexato, sulfasalazina o leflunomida: el sujeto ha recibido tratamiento durante ? 3 meses, con una dosis estable (no debe superar los 25 mg de metotrexato por semana, los 3 g de sulfasalazina al día o los 20 mg de leflunomida al día) durante ? 4 semanas antes del inicio del producto en investigación.
    Para los sujetos que reciben corticosteroides orales: el sujeto debe estar recibiendo una dosis estable (no debe superar el equivalente a 10 mg de prednisona al día) durante ? 4 semanas antes del inicio del producto en investigación.
    E.4Principal exclusion criteria
    Other Medical Conditions:
    - Subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, diabetes, anemia) considered by the investigator to be clinically significant and uncontrolled.
    - Subject has any concurrent medical condition or electrocardiogram (ECG) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject.


    Washouts or Other Treatments
    - Subject has used commercially available or investigational biologic therapies for psoriasis and/or psoriatic arthritis as follows:
    ? anti-tumor necrosis factor (TNF) therapy within 2 months prior to investigational product initiation
    ? other experimental or commercially available biologic therapies for psoriasis and/or psoriatic arthritis within 3 months prior to investigational product initiation
    ? anti-IL17 or anti-IL12/IL23 biologic therapy, including brodalumab, secukinumab, ixekizumab, ustekinumab, briakinumab at any time
    ? rituximab at any time

    General
    - Subject is currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s) prior to screening.
    - Other investigational procedures while participating in this study are excluded.
    - Subject has known sensitivity to any of the products or components to be administered during dosing.
    - Women of reproductive potential who are not willing to use an acceptable form of birth control during the study and for an additional 8 weeks after the last dose of study drug.
    - Women who are lactating/breastfeeding or planning to breastfeed during the study and for an additional 8 weeks after the last dose of Amgen study drug.
    Otras enfermedades
    El sujeto tiene antecedentes conocidos de tuberculosis activa.
    El sujeto presenta una prueba positiva de tuberculosis durante la selección, definida como:
    Derivado proteico purificado positivo (PPD) (? 5 mm de induración en las 48 a 72 horas posteriores a la realización de la prueba).
    O
    Prueba de Quantiferon positiva.
    -Se permite la inclusión de sujetos con una prueba de PPD positiva y antecedentes de vacunación con el bacilo de Calmette-Guérin si tienen una prueba de Quantiferon negativa.
    -Se permiten sujetos con una prueba de PPD positiva (sin antecedentes de vacunación con el bacilo de Calmette-Guérin) o sujetos con una prueba de Quantiferon positiva o indeterminada si cumplen con TODO lo siguiente:
    No presentan síntomas según la hoja de trabajo de tuberculosis proporcionada por Amgen;
    Antecedentes documentados de un ciclo completo de profilaxis adecuada (tratamiento finalizado para la TB latente) según el tratamiento estándar local antes del inicio del producto en investigación.
    No hay exposición conocida a un caso de tuberculosis activa tras la profilaxis más reciente.
    Ausencia de signos de tuberculosis activa en la radiografía torácica durante los 3 meses previos a la primera dosis del producto en investigación.
    El sujeto tiene programada una intervención quirúrgica entre el inicio del estudio y la evaluación de la semana 52.
    El sujeto presenta una infección activa o antecedentes de infecciones como las siguientes:
    -Cualquier infección activa para la que se administraron antiinfecciosos sistémicos durante los 28 días previos a la primera dosis del producto en investigación.
    -Una infección grave, definida como aquella que requiere hospitalización o antiinfecciosos intravenosos durante las 8 semanas previas a la primera dosis del producto en investigación.
    -Infecciones recurrentes o crónicas u otra infección activa que, en opinión del investigador, pueda hacer que este estudio sea perjudicial para el sujeto.
    El sujeto presenta cualquier enfermedad sistémica (p. ej., insuficiencia renal, insuficiencia cardíaca, hipertensión, enfermedad hepática, diabetes o anemia) que el investigador considere clínicamente significativa y no controlada.
    El sujeto tiene antecedentes conocidos del virus de la inmunodeficiencia humana.
    El sujeto presenta un estudio serológico positivo para el antígeno de superficie de la hepatitis B, anticuerpos del núcleo de la hepatitis B o anticuerpos del virus de la hepatitis C.
    El sujeto tuvo un infarto de miocardio o una angina de pecho inestable o infarto cerebral durante los 12 meses previos a la primera dosis del producto en investigación.
    El sujeto presenta cualquier neoplasia maligna activa, incluida la evidencia de carcinoma cutáneo de células basales o de células escamosas o melanoma.
    El sujeto tiene antecedentes de neoplasia maligna en los últimos 5 años previos EXCEPTO carcinoma cutáneo de células escamosas o de células basales, cáncer cervical in situ o carcinoma ductal in situ de mama tratados y considerados curados.
    El sujeto presenta cualquier enfermedad concurrente o una anomalía en el electrocardiograma (ECG) que, en opinión del investigador, podría hacer que este estudio sea perjudicial para el sujeto.
    El sujeto tiene enfermedad de Crohn activa o antecedentes de la enfermedad de Crohn.
    E.5 End points
    E.5.1Primary end point(s)
    ACR20 response at week 16
    Respuesta ACR20 en la semana 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Semana 16
    E.5.2Secondary end point(s)
    Key secondary Endpoints:
    PASI 75 at week 16
    mTSS change from baseline at week 24
    PASI 75 en la semana 16, y cambio en la mTSS con respecto al nivel basal en la semana 24.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PASI 75 at week 16
    mTSS change from baseline at week 24
    PASI 75 en la semana 16, y cambio en la mTSS con respecto al nivel basal en la semana 24.
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.2.3.1Comparator description
    randomized, double-blind, placebo-controlled study with long term extension
    E.8.2.4Number of treatment arms in the trial3
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA71
    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
    Belgium
    Canada
    France
    Greece
    Italy
    Netherlands
    Czech Republic
    Hungary
    Spain
    Mexico
    Poland
    Russian Federation
    Switzerland
    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
    LVLS
    Última Visita, 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: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 322
    F.4.2.2In the whole clinical trial 630
    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)
    Plans for treatment of care after the subject has ended participation are not different from the expected normal treatment for this condition
    Los planes de tratamiento para la atención del paciente una vez finalizada su participación no son diferentes del tratamiento esperado en esta condición.
    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 Decision2014-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-10-22
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