Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-005412-25
    Sponsor's Protocol Code Number:CAIN457A2312
    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:2013-03-06
    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 number2012-005412-25
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Demonstrate the Efficacy at 16 Weeks of Secukinumab 150 and 300 mg s.c. and to Assess Safety, Tolerability and Long-term Efficacy up to 80 Weeks in Subjects With Moderate to Severe Palmoplantar Psoriasis
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo para demostrar la eficacia a las 16 semanas de secukinumab 150 y 300 mg s.c. y para evaluar la seguridad, tolerabilidad y la eficacia a largo plazo hasta 80 semanas en pacientes con psoriasis palmoplantar moderada a severa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis
    Estudio de seguridad, tolerabilidad y eficacia de secukinumab en pacientes con psoriasis palmoplantar moderada a severa
    A.4.1Sponsor's protocol code numberCAIN457A2312
    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 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 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 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 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
    moderate to severe palmoplantar psoriasis
    psoriasis palmoplantar de moderada a severa
    E.1.1.1Medical condition in easily understood language
    Psoriasis looks like red, raised scaly areas of the skin, it can also involve the palms of hands and soles of feet.
    La psoriasis se muestra roja, con areas de piel descamadas y engrosadas, también puede aparecer en las palmas de las manos y en las suelas de los pies
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10037158
    E.1.2Term Psoriasis palm & soles
    E.1.2System Organ Class 100000004858
    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 the superiority of secukinumab 150 mg and/or 300 mg to placebo in subjects with moderate to severe palmoplantar psoriasis as assessed by the palmoplantar Investigator's Global Assessment (ppIGA) at Week 16
    Demostrar la superioridad de secukinumab 150 mg y/o 300 mg frente al placebo en pacientes con psoriasis palmoplantar de moderada a severa evaluada mediante la Evaluación Global de la psoriasis palmoplantar efectuada por el Investigador (ppIGA) en la Semana 16
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of secukinumab 150 mg and 300 mg in subjects with moderate to severe palmoplantar psoriasis as assessed by the ppIGA over time up to Week 16 compared to
    placebo, and over time up to Week 80
    ? To assess the efficacy of secukinumab 150 mg and 300 mg in subjects with moderate to severe palmoplantar psoriasis as assessed by the ppPASI (palmoplantar Psoriasis Area and
    Severity Index) over time up to Week 16 compared to placebo, and over time up to Week 80
    ? To investigate the overall safety and tolerability of secukinumab 150mg and 300 mg
    - Evaluar la eficacia de secukinumab 150 mg y 300 mg en pacientes con psoriasis palmoplantar de moderada a severa evaluada mediante la ppIGA hasta la Semana 16 en comparación con placebo, y hasta la Semana 80
    ? Evaluar la eficacia de secukinumab 150 mg y 300 mg en pacientes con psoriasis palmoplantar de moderada a severa evaluada mediante el ppPASI (Índice de severidad y área de la psoriasis palmoplantar) hasta la Semana 16 en comparación con placebo, y hasta la Semana 80
    ? Investigar la seguridad global y la tolerabilidad de secukinumab 150 mg y 300 mg
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?Men or women at least 18 years at the time of screening
    ?Subjects should have chronic moderate to severe plaque type psoriasis for at least 6 months prior to entering the study, including significant involvement of plaque type psoriasis on the palms and soles defined by a palmplantar Investiator Global Assessment (ppIGA) score of > 3 (on a 5-point scale) and at least one extra palmoplantar plaque on the skin
    ?Subjects should be candidates for systemic therapy, which means having psoriasis considered inadequately controlled by topical treatment (including super potent topical corticosteroid) and/or phototherapy and/or previous systemic therapy
    2. Hombres o mujeres de al menos 18 años de edad en el momento de la selección
    3. Psoriasis en placas crónica de moderada a severa durante al menos 6 meses antes de la aleatorización, incluida la visita basal: afectación significativa de las palmas y plantas definida por una puntuación ppIGA de > 3 (en una escala de 5 puntos) y al menos una placa no palmoplantar en la piel
    4. Ser candidato a terapia sistémica, definida como tener psoriasis que se considere inadecuadamente controlada mediante: Tratamiento tópico (incluido corticoesteroide tópico muy potente) y/o Fototerapia y/o Terapia sistémica previa
    E.4Principal exclusion criteria
    ?Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis)
    ?Drug-induced psoriasis (e.g. new onset or current exacerbation from ?-blockers, calcium channel inhibitors or lithium)
    ?Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Washout periods have to be adhered to.
    ?Prior exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or IL-17 Receptor
    ?Receipt of any investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer
    ?Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy
    ?History of hypersensitivity to constituents of the study treatment. Other protocol-defined inclusion/exclusion criteria may apply
    1. Formas de psoriasis distintas a la psoriasis en placas crónica (p. ej., psoriasis pustulosa, pustulosis palmoplantar, acrodermatitis de Hallopeau, psoriasis eritrodérmica y en gotas)
    2. Psoriasis inducida por fármacos (p. ej., nuevo inicio o exacerbación actual debido a betabloqueantes, inhibidores de los canales del calcio o litio)
    3. Uso actual de tratamientos prohibidos (p. ej., corticoesteroides (CS) tópicos o sistémicos, terapia UV). Han de respetarse los períodos de lavado
    4. Exposición previa a secukinumab (AIN457) o a cualquier otro fármaco biológico que se dirija directamente a la IL-17 o al receptor de IL-17.
    5. Recibir cualquier fármaco en investigación en las 4 semanas previas al inicio de la medicación del estudio o en un período de 5 semividas previas al inicio del tratamiento en investigación, lo que sea más largo
    8. Enfermedades inflamatorias activas en curso distintas a psoriasis que puedan confundir la evaluación del beneficio de la terapia con secukinumab
    9. Enfermedad actual severa, significativa o no controlada (incluida, pero sin limitarse a metabólica, hematológica, renal, hepática, pulmonar, neurológica, endocrina, cardíaca, infecciosa o gastrointestinal, hipertensión no controlada (sistólica ? 160 mmHg y/o diastólica ? 95 mmHg), insuficiencia cardíaca congestiva [estado de la Asociación Cardíaca de Nueva York de clase III o IV], infarto de miocardio en las 26 semanas previas a la aleatorización), que a juicio del investigador clínico hace que el paciente no sea idóneo para el ensayo, por lo que corre un mayor riesgo
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:palmoplantar Investigator Global Assessmnet (ppIGA) response after 16 weeks of treatment. Each of the treatment group will be compared to placebo.
    Eficacia: Evaluación Global de la psoriasis palmoplantar efectuada por el Investigador (ppIGA) después de 16 Semanas de tratamiento. Cada grupo de tratatmiento se comparara con placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 16 weeks
    Basal, Semana 16
    E.5.2Secondary end point(s)
    1. Efficacy: palmoplantar Investigator Global Assessment (ppIGA) response

    2. Efficacy: palmoplantar Psoriasis Area and Severity Index (ppPASI) over time up to Week 16 compared to placebo, and over time up to Week 80

    3. Overall safety and tolerability of secukinumab 150 mg and 300 mg

    4. Investigate the development of immunogenicity against secukinumab
    1. Eficacia: respuesta a la Evaluación Global de la psoriasis palmoplantar efectuada por el Investigador (ppIGA)
    2. Eficacia: ppPASI (Índice de severidad y área de la psoriasis palmoplantar) hasta la Semana 16 comparado con placebo, y hasta la Semana 80
    3. seguridad global y tolerabilidad de secukinumab 150 mg y 300 mg
    4. Investigar el desarrollo de inmunogenicidad frente a secukinumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Over time up to Week 16 compared to placebo, and over time up to Week 80

    2. 16 weeks, 80 weeks

    3. Baseline, up to 88 weeks

    4. Baseline, 32 weeks, 80 weeks, 88 weeks
    1. Hasta la Semana 16 comparando con placebo, y hasta la Semana 80

    2. 16 semanas, 80 semanas

    3. Basal, hasta 88 semanas

    4. Basal, 32 semanas, 80 semanas, 88 semanas
    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 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
    Immunogenicity
    Inmunogenicidad
    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 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 Yes
    E.8.2.3Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Finland
    Hungary
    Israel
    Netherlands
    Norway
    Portugal
    Russian Federation
    Slovakia
    Spain
    Turkey
    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
    ultima visita del ultimo 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 months4
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days15
    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: 191
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 96
    F.4.2.2In the whole clinical trial 201
    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)
    When the subject leaves the study the investigator will discuss the different medications or possible alternatives that are available to treat the subject's psoriasis.
    Cuando un paciente abandone el estudio el investigador discutirá los diferentes tratamientos o las posibles alternativas que hay disponibles para tratar la psoriasis
    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 Decision2013-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-15
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 12:44:18 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA