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    Summary
    EudraCT Number:2015-002394-38
    Sponsor's Protocol Code Number:CAIN457F2354
    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:2016-02-24
    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 number2015-002394-38
    A.3Full title of the trial
    A 52-week, multicenter study to assess the time course of response to secukinumab on joint inflammation using Power Doppler ultrasonography in patients with active psoriatic arthritis
    Estudio multicéntrico de 52 semanas para evaluar la evolución temporal de la respuesta a secukinumab en la inflamación articular mediante ecografía Power Doppler en pacientes con artritis psoriásica activa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of application of Power Doppler ultrasonography (PDUS) to measure response to secukinumab treatment in patients with active psoriatic arthritis (PsA)
    Estudio sobre la aplicación de la ecografía Power Doppler (PDUS) para determinar la respuesta al tratamiento con secukinumab en pacientes con artritis psoriásica (APs) activa.
    A.4.1Sponsor's protocol code numberCAIN457F2354
    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 SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointDepartamento Médico (ICRO)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34900353036
    B.5.5Fax number+34932479903
    B.5.6E-maileecc.novartis@novartis.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 Yes
    D.2.1.1.1Trade name COSENTYX
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameSecukinumab
    D.3.2Product code AIN457
    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 INNSecukinumab
    D.3.9.1CAS number 1229022-83-6
    D.3.9.2Current sponsor codeAIN457
    D.3.9.3Other descriptive nameSECUKINUMAB
    D.3.9.4EV Substance CodeSUB33242
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    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] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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 demonstrate that there is a difference between secukinumab and placebo in terms of joint synovitis response over 12 weeks as measured by the PDUS Global OMERACT-EULAR Synovitis Score (GLOESS) of the affected joints (out of 48 joints) in PsA patients with an inadequate response (IR) to non biologic DMARDs.
    Demostrar que existe una diferencia entre secukinumab y placebo en términos de respuesta de la sinovitis articular a lo largo de 12 semanas, determin ada mediante la puntuación global para la synovitis (GLOESS) de OMERACT - EULAR mediante PDUS de las articulaciones afectadas (de un total de 48 articulaciones) en pacientes con APs con una respuesta inadecuada (RI) a FAME no biológicos
    E.2.2Secondary objectives of the trial
    Key secondary objectives:
    To demonstrate that the efficacy of secukinumab at Week 12 is superior to placebo based on the proportion of patients achieving:
    - an ACR 20 response
    - an ACR 50 response
    To demonstrate that the clinical response of secukinumab at Week 12 is superior to placebo based on the change in SPARCC enthesitis index from Baseline to Week 12.
    Demostrar que la eficacia de secukinumab en la semana 12 es superior a la del placebo en función del porcentaje de pacientes que alcanzan:
    -una respuesta ACR 20
    -una respuesta ACR 50
    Demostrar que la respuesta clínica de secukinumab en la semana 12 es superior a la del placebo en función del cambio en el índice de entesitis SPARCC desde la visita basal hasta la semana 12.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Optional PDUS Sub-study
    Date: 2015-11-20
    Version: 00
    Objectives:
    -Explore early signs of response in the skin and nails of patients with concomitant moderate-to-severe psoriasis or nail psoriasis, based on the change from Baseline of Power Doppler signal, at each evaluation time, using a semi quantitative score (0 = absence or up to 2 spots, 1 = < 25% vascularization of the plaque/nail bed, 2 = > 25% and < 50% vascularization of the plaque/nail bed, 3 = > 50% vascularization of the plaque/nail bed).
    - Explore time course of response to secukinumab on PDUS dactylitis in patients with concomitant dactylitis will be evaluated based on the change from Baseline at each evaluation time of the elementary components involved: synovitis (using the OMERACT-EULAR scoring system), flexor tendon tenosynovitis (using the OMERACT scoring system for evaluating the presence or absence of tenosynovitis) (Naredo et al 2013), and subcutaneous involvement (using the decrease of the thickness and the disappearance of the power Doppler signal if present (Gutierrez et al 2012)).
    -Explore the rate of response with secukinumab between Week 4 and Week 12 assessed by clinical evaluation using dactylitis count by Leeds Dactylitis Index (LDI) and by the PDUS of dactylitis.
    Titulo: Subestudio de PDUS opcional
    Fecha: 2015-11-20
    Version: 00
    Objetivos:
    -Evaluar los signos tempranos de respuesta cutánea y ungueal de pacientes con psoriasis o psoriasis ungueal concomitante de moderada a grave, en función del cambio con respecto a la visita Basal en la señal del Power Doppler, en cada momento de evaluación, usando una puntuación semicuantitativa (0 = ausencia o un máximo de 2 puntos, 1 = < 25% de vascularización de la placa/lecho ungueal, 2 = > 25% y < 50% de vascularización de la placa/lecho ungueal, 3 = > 50% de vascularización de la placa/lecho ungueal).
    -Evaluar la evolución temporal de la respuesta a secukinumab en la dactilitis determinada mediante la PDUS en pacientes con dactilitis concomitante, que se evaluará en función del cambio con respecto a la visita Basal en cada momento de evaluación de los componentes elementales afectados: sinovitis (usando el sistema de puntuación OMERACT-EULAR), tenosinovitis del tendón flexor (usando el sistema de puntuación OMERACT para la evaluación de la presencia o ausencia de tenosinovitis) (Naredo y cols., 2013), y afectación subcutánea, usando la reducción del engrosamiento y la desaparición de la señal en el Power Doppler, si existía [Gutierrez y cols., 2012]).
    -Evaluar la tasa de respuesta con secukinumab entre la semana 4 y la 12, determinada mediante evaluación clínica usando el número de dactilitis a partir del índice de dactilitis de Leeds (LDI) y mediante la PDUS de las dactilitis.
    E.3Principal inclusion criteria
    - Patient must be able to understand and communicate with the Investigator and comply with the requirements of the study and must provide written, signed and dated informed consent before any study assessment is performed.
    - Male or female patients at least 18 years of age.
    - Diagnosis of PsA as per CASPAR with active PsA for at least 6 months and a TJC >/= 3 of 78 and SJC >/= 3 of 76 at Baseline.
    - Patients must have a total synovitis PDUS score >/= 2 and inflammation related to PD signal >/= 2 for at least 2 (affected joints as observed via PDUS) of 48 joints at the Screening visit and at the Baseline visit (before infusion).
    - At least 1 clinically-involved enthesitis site at Screening and at the Baseline visit (before infusion) defined by SPARCC index different from 0.
    Other protocol defined inclusion criteria may apply.
    - El paciente debe ser capaz de entender al investigador y comunicarse con él, así como de cumplir con los requisitos del estudio y otorgar un consentimiento informado por escrito, firmado y fechado, antes de que se realice cualquier evaluación relacionada con el estudio.
    - Pacientes varones o mujeres de al menos 18 años de edad.
    -Diagnóstico de APs según los criterios CASPAR con APs activa durante al menos 6 meses y un NAD >/= 3 de 78 y un NAT >/= 3 de 76 en la visita basal.
    - Los pacientes deben tener una puntuación total de la sinovitis mediante PDUS >/= 2 y una inflamación relacionada con la señal PD >/= 2 en al menos 2 (articulaciones afectadas observadas mediante PDUS) de 48 articulaciones en la visita de selección y en la visita basal (antes de la inyección).
    - Al menos un punto de entesitis con afectación clínica en la selección y en la visita basal (antes de la inyección), definido con un índice SPARCC diferente de 0.
    Se pueden aplicar otros criterios de inclusion descritos en el protocolo.
    E.4Principal exclusion criteria
    -Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process obtained within 3 months prior to Screening and evaluated by a qualified physician.
    -Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor.
    -Any change in the dose of oral corticosteroids in the last 4 weeks prior to the Baseline visit or use of i.v. intramuscular or intra-articular corticosteroid during the last 4 weeks prior to the enrollment visit.
    -Patients who have previously been treated with TNF? inhibitors (investigational or approved).
    -History of hypersensitivity to the study drug or its excipients or to drugs of similar classes.
    -Previous treatment with any cell-depleting therapies including but not limited to anti CD20 investigational agents (e.g. CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti CD19).
    -Prohibited psoriasis treatments/medications with topical corticosteroids in the last 4 weeks prior to randomization.
    -Pregnant or nursing (lactating) women.
    Other protocol defined exclusion criteria may apply.
    -Radiografía de tórax o RM de tórax con signos de proceso maligno o infeccioso en curso, obtenidas en los 3 meses previos a la selección y evaluadas por un médico cualificado.
    -Exposición previa a secukinumab o a otro fármaco biológico dirigido directamente a la IL-17 o a su receptor.
    -Cualquier modificación en la dosis de corticosteroides orales en las últimas 4 semanas antes de la visita basal o uso de corticosteroides i.v., intramusculares o intraarticulares durante las 4 semanas previas a la visita de inclusión.
    -Pacientes que hayan recibido tratamiento previo con inhibidores del TNF? (en fase de investigación o aprobados).
    -Tratamiento previo con cualquier terapia de depleción celular, incluyendo, entre otros, fármacos anti-CD20 en fase de investigación (p. ej., CAMPATH, anti-CD4, anti-CD5, anti-CD3 y anti-CD19).
    -Tratamientos/medicamentos prohibidos para la psoriasis con corticosteroides de uso tópico en las 4 semanas previas a la aleatorización
    -Mujeres embarazadas o en periodo de lactancia
    Se pueden aplicar otros criterios de exclusión descritos en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Difference between secukinumab and placebo in terms of joint synovitis
    Diferencia entre secukinumab y placebo en términos de respuesta de la sinovitis articular
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 semanas
    E.5.2Secondary end point(s)
    - American College of Rheumatology (ACR)-20
    - ACR-50
    - Spondyloarthritis Research Consortium of Canada(SPARCC)
    - American College of Rheumatology (ACR)-20
    - ACR-50
    - Consorcio de investigación sobre la Espondiloartritis de Canadá (SPARCC)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to Week 12
    visita basal hasta la semana 12
    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) 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 No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Austria
    Belgium
    Canada
    Colombia
    Czech Republic
    France
    Germany
    Hungary
    Ireland
    Italy
    Mexico
    Netherlands
    Norway
    Portugal
    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
    Última Visita Último Paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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: 193
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state51
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 165
    F.4.2.2In the whole clinical trial 218
    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 Investigator must provide follow-up medical care for all patients who are prematurely withdrawn from the study, or must refer them for appropriate ongoing care. This care may include initiating another treatment outside of the study as deemed appropriate by the Investigator. This treatment may be any non-biologic DMARD. In case of a biologic treatment, a waiting period of 3 months before initiating the treatment is recommended.
    El investigador deberá proporcionar atención médica de seguimiento a todos los pacientes que se retiren del estudio de forma prematura, o deberá derivarlos para que reciban el tratamiento continuado adecuado. Este tratamiento puede incluir la iniciación de otro tratamiento fuera del estudio según lo considere el investigador. Este tratamiento puede incluir un FAME no biológico. En caso de iniciar un tratamiento biológico, habrá que esperar un periodo de 3 meses antes de iniciar el tratamiento.
    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 Decision2016-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-10
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