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    Summary
    EudraCT Number:2017-000679-10
    Sponsor's Protocol Code Number:CAIN457K2340
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-09-18
    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 number2017-000679-10
    A.3Full title of the trial
    A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis
    Estudio multicéntrico, aleatorizado, parcialmente ciego, con control activo para demostrar la reducción de la progresión radiográfica con secukinumab frente a GP2017 (biosimilar de adalimumab) en la semana 104 y evaluar la seguridad, tolerabilidad y eficacia a largo plazo en un periodo máximo de 2 años en pacientes con espondilitis anquilosante activa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)
    Estudio del efecto de secukinumab en la progresión radiográfica de la espondilitis anquilosante en comparación con GP2017 (biosimilar de adalimumab)
    A.3.2Name or abbreviated title of the trial where available
    SURPASS
    A.4.1Sponsor's protocol code numberCAIN457K2340
    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
    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+3493 2479903
    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.3.4Pharmaceutical 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 nameadalimumab
    D.3.2Product code GP2017
    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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.2Current sponsor codeGP2017
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Ankylosing spondylitis
    Espondilitis anquilosante
    E.1.1.1Medical condition in easily understood language
    Bechterew`s syndrome
    Síndrome de Bechterew
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 demonstrate the proportion of subjects on secukinumab (combined 150 mg s.c. and 300 mg s.c.) with no radiographic progression as measured by mSASSS at Week 104 is superior to subjects on GP2017 (adalimumab biosimilar 40 mg s.c.).
    Demostrar que la proporción de sujetos en tratamiento con secukinumab (combinación 150 mg s.c. y 300 mg s.c.) sin progresión radiográfica, medido mediante el mSASSS, en la semana 104 es superior a la de los sujetos que reciben GP2017 (biosimilar de adalimumab 40mg s.c.).
    E.2.2Secondary objectives of the trial
    -To demonstrate the proportion of subjects on AIN457 (150mg sc or 300mg sc) with no radiographic progression at W104 is superior to subjects on GP2017
    -To demonstrate the change from baseline in mSASSS in subjects on AIN457 (150mg sc or 300mg sc) is superior to GP2017 at W104
    -To demonstrate the proportion of subjects with a syndesmophyte at baseline with no new syndesmophytes at W104 on AIN457 (150mg sc or 300mg sc) is superior to GP2017
    -To evaluate the Berlin SI joint edema score in subjects on AIN457 (150mg sc and 300mg sc) at W104 versus GP2017 (in a subset of subjects at selected sites)
    -To evaluate the ASspiMRI-a Berlin modification score in subjects on AIN457 (150mg sc and 300mg sc) at W104 versus GP2017 (in a subset of subjects at selected sites)
    -To evaluate ASAS20 response, ASAS40 response, ASAS partial remission and ASDAS inactive disease in subjects on AIn457 150mg sc compared to AIN457 300mg sc at W104
    -Overall safety and tolerability of AIN457
    Demostrar:
    - la proporción de sujetos en tto con AIN457 sin progresión radiográfica en la sem 104 es superior a la de los que reciben GP2017
    - que el cambio respecto a la basal en el mSASSS en sujetos en tto con AIN457 es superior al de los que reciben GP2017 en la sem. 104
    - que la proporción de sujetos con un sindesmófito en la basal y que no presentan más sindesmófitos en la sem. 104 con AIN457 es superior a la de los que reciben GP2017
    Evaluar:
    - el edema en articulaciones sacroilíacas mediante el índice de Berlín en sujetos en tto con AIN457 en la semana 104 frente a GP2017 (en subconjunto de sujetos)
    - el índice ASspiMRI-a según la modificación de Berlin en sujetos en tto con AIN457 en la sem. 104 frente a GP2017 (en subconjunto de sujetos)
    - las respuestas ASAS 20, ASAS 40, remisión parcial según la ASAS y enf. inactiva según la ASDAS en sujetos en tto con AIn457 150mg sc comparado con AIN457 300mg sc en la sem. W104
    - Seguridad y tolerabilidad globales de AIN457
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or non-pregnant, non-nursing female patients at least 18 years of age.
    - Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS despite previous or current NSAID/non biologic DMARD therapy.
    - Active AS assessed by total BASDAI >= 4 on a scale of 0-10.
    - Spinal pain as measured by BASDAI question #2 >=4 (0-10).
    - Total back pain as measured by visual analog scale (VAS) >= 40 mm (0-100 mm).
    - hsCRP >= 5mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray.

    Other protocol-defined inclusion criteria may apply,
    - Pacientes varones o mujeres que no estén embarazadas ni en periodo de lactancia de al menos 18 años de edad.
    - Diagnóstico de EA de moderada a grave con pruebas radiológicas (radiografía interpretada a nivel central) que cumplan los criterios de Nueva York modificados para EA
    - EA activa según un valor total del BASDAI >= 4 (0-10) en la basal.
    - Dolor espinal medido según la pregunta n.º 2 del BASDAI >= 4 (0-10) en la basal.
    - Dolor de espalda total medido según EVA >= 40 mm (0-100 mm) en la basal.
    - PCRus >= 5 mg/l O presencia de al menos 1 sindesmófito en la radiografía de la columna vertebral interpretada a nivel central.

    Puede aplicar otros criterios de inclusión definidos en el protocolo.
    E.4Principal exclusion criteria
    - Patients with total ankylosis of the spine.
    - Pregnant or nursing (lactating) women.
    - Evidence of ongoing infectious or malignant process.
    - Previous exposure to any biologic immunomodulating agent, including those targeting IL-17, IL-17 receptor or TNF alfa.
    - Subjects taking high potency opioid analgesics.
    - Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents.

    Other protocol-defined exclusion criteria may apply,
    - Pacientes con anquilosis total de la columna vertebral.
    - Mujeres embarazadas o en periodo de lactancia.
    - Evidencia de proceso infeccioso o maligno en curso,
    - Exposición previa a cualquier fármaco inmunomodulador biológico, incluidos los que se dirigen a IL-17, el receptor de IL-17 o TNF alfa
    - Pacientes que tomen analgésicos opioides de alta potencia
    - Pacientes tratados previamente con terapia de depleción celular, incluyendo, entre otros, anti-CD20, fármacos en investigación.


    Puede aplicar otros criterios de exclusión definidos en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    No radiographic progression as measured by modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) for combined 150 mg sc and 300 mg sc secukinumab versus GP2017)
    Ausencia de progresión radiográfica medida mediante la escala Stoke Ankylosing Spondylitis Spinal Score (mSASSS), para secukinumab 150 mg sc combinado con 300 mg sc, frente a GP2017.
    E.5.1.1Timepoint(s) of evaluation of this end point
    104 weeks
    104 semanas
    E.5.2Secondary end point(s)
    - No radiographic progression as measured by modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) (150 mg sc or 300 mg sc secukinumab versus GP2017).
    - Change from baseline in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS).
    - No new syndesmophyte as measured by mSASSS.
    - Assessment of SpondyloArthritis International Society 20 (ASAS20).
    - ASAS 40.
    - ASAS partial remission.
    - Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease.
    - Berlin sacroiliac (SI) joint edema score.
    - Ankylosing Spondylitis Spine Magnetic Resonance Imaging - activity (ASspiMRI-a) Berlin modification score.
    - Ausencia de progresión radiográfica medida mediante la escala Stoke Ankylosing Spondylitis Spinal Score (mSASSS), (150 mg sc o 300 mg sc de secukinumab frente a GP2017).
    -Cambio respecto a la basal en la escala Stoke Ankylosing Spondylitis Spinal Score mSASSS
    - No presentar nuevos sindesmófitos medidos mediante la escala mSASSS
    - Evaluación de la escala SpondyloArthritis International Society 20 (ASAS20).
    - ASAS 40.
    - ASAS en remisión parcial
    E.5.2.1Timepoint(s) of evaluation of this end point
    104 weeks
    104 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Los ptes sabe si recibieron PR1 o PR2, pero no saben la dosis de PR1 (150 o 300mg) que han recibido
    Pts know if they receive PR1 or PR2;but they don`t know the dose of PR1 (150 or 300mg) they receive
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA101
    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
    Australia
    Belgium
    Canada
    Chile
    Colombia
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Israel
    Korea, Republic of
    Mexico
    Netherlands
    Peru
    Philippines
    Poland
    Portugal
    Romania
    Russian Federation
    Slovakia
    South Africa
    Spain
    Taiwan
    Turkey
    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
    LPLV
    Ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days21
    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: 753
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 379
    F.4.2.2In the whole clinical trial 837
    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 subjects 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 Bx treatment,a waiting period of 3 mos for a subject previously on AIN457 & 4 mos for a subject previously on GP2017 before initiating the treatment is recommended.
    El investigador debe realizar seguimiento médico a todos los sujetos que abandonen prematuramente el estudio, o debe remitirlos para que reciban la atención medica apropiada. Esta atención medica, según lo considere apropiado el investigador, puede incluir el inicio de otro tto fuera del estudio . Este tto puede ser cualquier DMARD no biológico. En caso de un tto Bx, antes de iniciar el tto, se recomienda un período de espera de 3 meses para el grupo AIN457 y 4 meses para el grupo GP2017.
    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 Decision2017-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-09
    P. End of Trial
    P.End of Trial StatusOngoing
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