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    Summary
    EudraCT Number:2015-003701-42
    Sponsor's Protocol Code Number:CAIN457A3401
    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:2015-12-28
    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 number2015-003701-42
    A.3Full title of the trial
    An open-label, prospective, non-randomized, multicenter study to evaluate clear skin effect on health related quality of life outcomes at 16 and 52 weeks in patients with moderate to severe plaque psoriasis treated with secukinumab 300 mg s.c. with or without previous exposure to systemic therapy.
    Ensayo abierto, prospectivo, no aleatorizado, multicéntrico para evaluar el efecto de piel blanqueada en los resultados de calidad de vida relacionada con la salud a las 16 y 52 semanas en pacientes con psoriasis en placas de moderada a grave tratados con 300 mg secukinumab s.c. con o sin exposición previa a terapia sistémica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate clear skin effect in patients with plaque psoriasis.
    Uno estudio para evaluar el efecto de piel blanqueada en pacientes con psoriasis en placas.
    A.4.1Sponsor's protocol code numberCAIN457A3401
    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+34930353036
    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 Limited
    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 nameCosentyx (secukinumab)
    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/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 No
    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
    Plaque psoriasis
    Psoriasis en placas
    E.1.1.1Medical condition in easily understood language
    Psoriasis looks like red, raised, scaly areas of the skin.
    La psoriasis parece como zonas rojas, engrosadas, escamosas de la piel.
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10050576
    E.1.2Term Psoriasis vulgaris
    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 assess the proportion of patients achieving a DLQI 0/1 response at Week 16 in 3 pre defined subpopulations and in the overall study population.
    Evaluar la proporción de pacientes que alcanza una respuesta del DLQI de 0/1 en la semana 16 en las tres subpoblaciones definidas previamente y en la población global del estudio.
    E.2.2Secondary objectives of the trial
    To assess:
    - The proportion of patients achieving a DLQI 0/1 response at Week 52 in 3 pre defined subpopulations and in the overall study population.
    - The effects of treatment with secukinumab 300 mg with respect to changes in EQ-5D©, HAQ©-DI, NRS, TSQM and PBI response over time up to Week 16 and Week 52 compared to baseline in 3 pre-defined subpopulations and in the overall study population.
    - The proportion of patients achieving PASI 50, PASI 75, PASI 90, PASI 100 and IGA mod 2011 0/1 responses at Week 16 and Week 52 in 3 pre-defined subpopulations and in the overall study population.
    - The proportion of patients with DLQI scores 2-5, 6-10, 11-20, 21-30 at Week 16 and Week 52 compared to Baselinein 3pre-defined subpopulations and in the overall study population.
    - The overall safety and tolerability of treatment with secukinumab 300 mg in 3 pre-defined subpopulations and in the overall study population.
    Evaluar:
    - La proporción de pacientes que alcanza una respuesta del DLQI de 0/1 en la semana 52 en las 3 subpoblaciones predefinidas y en la población global del estudio.
    - El efecto del tratamiento con secukinumab 300 mg en relación con los cambios en la respuesta al EQ-5D©, ID-HAQ©, EVN, TSQM y PBI hasta la semana 16 y 52 respecto a la visita basal en las 3 subpoblaciones predefinidas y en la población global del estudio.
    - La proporción de pacientes que alcanzan PASI 50, PASI 75, PASI 90, PASI 100 y respuestas IGA mod. 2011 de 0/1 en las semanas 16 y 52 en las 3 subpoblaciones predefinidas y en la población global del estudio.
    - La proporción de pacientes con puntuaciones del DLQI de 2-5, 6-10, 11-20, 21-30 en las semanas 16 y 52 respecto a la visita basal en las 3 subpoblaciones predefinidas y en la población global del estudio.
    - La seguridad y la tolerabilidad del tratamiento con secukinumab 300 mg en las 3 subpoblaciones predefinidas y en la población global del estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Men or women aged at least 18 years at time of Screening.
    - Moderate to severe plaque-type psoriasis diagnosed for at least 3 months prior to Screening and candidate for systemic therapy.
    - Other protocol defined inclusion criteria may apply. Please refer to the protocol.
    - Hombres o mujeres de al menos 18 años de edad en el momento de la selección.
    - Psoriasis en placas de moderada a grave diagnosticada al menos tres meses antes de la selección y candidatos a tratamiento sistémico.
    - Se pueden aplicar otros criterios de inclusión definidos en el protocolo. Por favor consulten el protocolo.
    E.4Principal exclusion criteria
    - Forms of psoriasis other than moderate to severe plaque-type psoriasis, e.g. drug-induced psoriasis at Screening.
    - Patients with previous treatment with any agent targeting interleukin (IL)-17 directly or IL-17 receptor A (e.g. secukinumab, ixekizumab, or brodalumab).
    - Pregnant or nursing (lactating) women
    - Women of child-bearing potential unless they use effective contraception
    - Other protocol-defined exclusion criteria may apply. Please refer to the protocol.
    - Formas de psoriasis diferentes a la psoriasis en placas de moderada a grave, p. ej., psoriasis inducida por fármacos en la selección.
    - Pacientes con tratamiento previo con cualquier fármaco dirigido directamente a la interleuquina (IL)-17 o al receptor A de la IL-17 (p. ej., secukinumab, ixekizumab o brodalumab).
    - Mujeres embarazadas o en periodo de lactancia
    - Mujeres en edad fértil salvo que esté utilizando métodos anticonceptivos eficaces
    - Se pueden aplicar otros criterios de exclusión definidos en el protocolo. Por favor consulten el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    DLQI 0/1 response
    Respuesta de DLQI de 0/1
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 16
    semana 16
    E.5.2Secondary end point(s)
    DLQI 0/1, EQ-5D, HAD-DI, NRS, TSQM, PBI, PASI 50/75/90/100, IGA mod 2011 0/1 response
    Respuesta DLQI 0/1, EQ-5D, HAD-DI, NRS, TSQM, PBI, PASI 50/75/90/100, IGA mod 2011 0/1
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 16 - week 52
    semana 16 - semana 52
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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.8.2.4Number 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 concerned52
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA235
    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
    European Union
    Israel
    Russian Federation
    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 del 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 months4
    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 months7
    E.8.9.2In all countries concerned by the trial days24
    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: 1470
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 145
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1505
    F.4.2.2In the whole clinical trial 1615
    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.
    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 Decision2016-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-28
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