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    Summary
    EudraCT Number:2017-000401-21
    Sponsor's Protocol Code Number:CAIN457H3301
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-04
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-000401-21
    A.3Full title of the trial
    SKIPPAIN (Speed of onset of SecuKinumab-Induced relief from Pain in Patients with AxIal SpoNdyloarthritis)
    A 24-week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of secukinumab in controlling spinal pain in patients with axial spondyloarthritis
    Studio multicentrico, randomizzato, in doppio cieco,
    controllato verso placebo, per valutare l’efficacia e la sicurezza di secukinumab nel controllo del dolore spinale in pazienti con spondiloartrite assiale – Studio SKIPPAIN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of secukinumab in controlling spinal pain in patients with axial spondyloarthritis
    Studio per valutare l’efficacia e la sicurezza di secukinumab nel controllo del dolore spinale in pazienti con spondiloartrite assiale
    A.3.2Name or abbreviated title of the trial where available
    SKIPPAIN (Speed of onset of SecuKinumab-Induced relief from Pain in Patients with Axial SpoNdyloarth
    SKIPPAIN – Velocità di insorgenza del sollievo dal dolore indotto da Secukinumab in pazienti con spo
    A.4.1Sponsor's protocol code numberCAIN457H3301
    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 PHARMA AG
    B.1.3.4CountrySwitzerland
    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 FARMA S.P.A.
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni, 1
    B.5.3.2Town/ cityOriggio (VA)
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number00390296541
    B.5.5Fax number0039029659066
    B.5.6E-mailinfo.studiclinici@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 - 150 MG - SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA -USO SOTTOCUTANEO - SIRINGA (VETRO) 1 ML (150MG/ML)- 1 SIRINGA PRERIEMPITA
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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
    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.3.9.4EV 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    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
    Axial Spondyloarthritis
    Spondiloartrite assiale
    E.1.1.1Medical condition in easily understood language
    Axial Spondyloarthritis
    Spondiloartrite assiale
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10071400
    E.1.2Term Axial spondyloarthritis
    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 assess the superiority of secukinumab 150
    mg compared to placebo in achieving a spinal pain score < 4 on a 0-10 NRS at Week 8
    Valutare la superiorità di secukinumab 150 mg rispetto a placebo nell’ottenimento di un punteggio
    per il dolore spinale < 4 su una NRS 0-10 alla Settimana 8
    E.2.2Secondary objectives of the trial
    To assess the superiority of secukinumab
    150 mg compared to placebo in achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score < 4 at Week 8
    Valutare la superiorità di secukinumab 150 mg rispetto a placebo nell’ottenimento di un punteggio
    dell’indice BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) < 4 alla Settimana 8
    E.2.3Trial contains a sub-study No
    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 non-pregnant, non-nursing female patients at least 18 years of age with diagnosis of axSpA (either AS or nr-axSpA) according to ASAS axSpA classification criteria to be applied in patients with back pain for at least 3 months and age of onset < 45 years:
    a. Sacroiliitis on imaging with = 1 SpA feature or
    b. Human Leukocyte Antigen-B27 (HLA-B27) positive with = 2 SpA features
    - Active axSpA as assessed by total BASDAI score = 4 at Baseline
    - Spinal pain NRS score > 4 at Baseline
    - Patients should have been on at least 2 different NSAIDs at the highest recommended dose for at least 4 weeks in total prior to randomization with an inadequate response or failure to respond, or less if therapy had to be withdrawn due to intolerance, toxicity or contraindication
    - Patients who are regularly taking NSAIDs (including cyclooxygenase-1 (COX-1) or cyclooxygenase-2 (COX-2) inhibitors) as part of
    their axSpA therapy are required to be on a stable dose for at least 2 weeks before randomization.
    - Patients who have previously on a TNFa inhibitor will be allowed entry into study after an appropriate what-out period prior to randomization:
    a. 4 weeks for Enbrel® (etanercept) – with a terminal half-life of 102 ± 30 hours (s.c. route)
    b. 8 weeks for Remicade® (infliximab) – with a terminal half-life of 8.0-9.5 days (i.v. infusion)
    c. 10 weeks for Humira® (adalimumab) – with a terminal half-life of 10-20 days (average 2 weeks) (s.c. route)
    d. 10 weeks for Simponi® (golimumab) – with a terminal half-life of 11-14 days
    e. 10 weeks for Cimzia® (certolizumab) – with a terminal half-life of 14 days
    - Pazienti in grado di comprendere e comunicare con lo sperimentatore e in grado di aderire ai requisiti dello studio; i pazienti devono fornire il proprio consenso informato scritto datato e firmato prima dell’effettuazione di qualsiasi valutazione dello studio
    - Pazienti di sesso maschile o pazienti di sesso femminile non in gravidanza o allattamento, di almeno 18 anni di età con diagnosi di axSpA (AS o nr-axSpA) in base ai criteri di classificazione ASAS per axSpA da applicare a pazienti con dolore lombare da almeno 3 mesi e età di insorgenza < 45 anni:
    a. Sacroileite alla valutazione per immagini con manifestazioni di SpA = 1 oppure
    b. Positività per antigene leucocitario umano B27 (Human Leukocyte Antigen-B27 - HLA-B27) con = 2 manifestazioni di SpA.
    - axSpA attiva valutata tramite punteggio totale BASDAI = 4 al Basale
    - Punteggio per NRS relativa al dolore spinale > 4 al Basale
    - I pazienti devono essere stati in trattamento con almeno 2 diversi FANS alla dose più alta raccomandata per almeno 4 settimane in totale prima della randomizzazione con risposta inadeguata o mancata risposta, o per un periodo inferiore di tempo se è stato necessario interrompere la terapia per intolleranza, tossicità o controindicazioni
    - Ai pazienti che assumono regolarmente FANS (compresi inibitori della ciclossigenasi 1 – COX-1 – o della ciclossigenasi-2 - COX-2 -) come parte della loro terapia per la axSpA è richiesto di essere in trattamento a dose stabile da almeno 2 settimane prima della randomizzazione
    - I pazienti che sono stati precedentemente in trattamento con inibitore di TFNa potranno entrare nello studio dopo un adeguato periodo di wash-out prima della randomizzazione:
    a. 4 settimane per Enbrel® (etanercept) con emivita terminale di 102 ± 30 ore (via sottocutanea)
    b. 8 settimane per Remicade® (infliximab) con emivita terminale di 8.0-9.5 giorni (infusione endovenosa)
    c. 10 settimane per Humira® (adalimumab) con emivita terminale di 10-20 giorni (media di 2 settimane) (via sottocutanea)
    d. 10 settimane per Simponi® (golimumab) con emivita terminale di 11-14 giorni
    e. 10 settimane per Cimzia® (certolizumab) con emivita terminale di 14 giorni
    E.4Principal exclusion criteria
    - Chest X-ray or magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process obtained within 3 months of Screening and evaluated by a qualified physician (otherwise chest X-ray or MRI is required to be performed at Screening)
    - Previous treatment with prohibited medication as outlined in Section 5.5.7 and Section 5.5.8 of the main protocol. Prohibited medication may be washed out before randomization in accordance with Section 5.5.7 and Section 5.5.8 of the main protocol
    - Previous exposure to secukinumab or any other biologic drug directly targeting interleukin-17 (IL-17) or interleukin-23 (IL-23).
    - Use of any investigational drug and/or devices within 4 weeks of randomization, or a period of 5 half-lives of the investigational drug, whichever is longer
    - History of hypersensitivity to the study drug or its excipients or to drugs of similar chemical classes.
    - Patients previously treated with any biological immunomodulating agents, except those targeting TNFa
    - Patients who have been exposed to more than one anti-tumor necrosis factor alpha (anti-TNFa) agent
    - Previous treatment with any cell-depleting therapies including but not limited to anti-cluster of differentiation (CD)20 or investigational agents (e.g. Campath®, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
    - Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
    - Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during entire study or longer if required by locally approved prescribing information (e.g. 20 weeks since last dose of secukinumab in the European Union (EU)).
    Other protocol-defined exclusion criteria may apply.
    - Radiografia toracica o risonanza magnetica con evidenza di processo infettivo o di natura maligna in corso, ottenuta entro 3 mesi dallo Screening e valutata da un medico qualificato (altrimenti si richiede l’effettuazione della radiografia toracica o della risonanza allo Screening)
    - Pregresso trattamento con farmaco proibito come indicato nella Sezione 5.5.7 e nella Sezione 5.5.8 del protocollo principale. Per il farmaco proibito deve essere effettuato un wash-out prima della randomizzazione in accordo alla Sezione 5.5.7 e alla Sezione 5.5.8 del protocollo principale
    - Pregressa esposizione a secukinumab o a qualsiasi altro farmaco biologico avente come target diretto interleuchina-17 (IL-17) o interleuchina-23 (IL-23)
    - Uso di qualsiasi farmaco e/o dispositivo sperimentale entro 4 settimane dalla randomizzazione, o un periodo di 5 emivite del farmaco sperimentale, a seconda di quale dei due periodi sia più lungo
    - Anamnesi di ipersensibilità al farmaco in studio o ai suoi eccipienti o a farmaci di classi chimiche simili
    - Pazienti precedentemente trattati con qualsiasi agente biologico immunomodulatore, ad eccezione di quelli aventi come target TNFa
    -Pazienti che sono stati esposti a più di un agente anti fattore di necrosi tumorale alfa (anti-TNFa)
    - Pregresso trattamento con qualsiasi terapia di deplezione cellulare, inclusi, ma non limitati a, agenti anti-cluster di differenziazione (CD920) o agenti sperimentali (ad es. Campath®, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
    - Donne in gravidanza o allattamento, con la gravidanza definita come lo stato di una donna dopo il concepimento e fino al termine della gestazione, confermato da un test di laboratorio positivo per gonadotropina corionica umana (human Corionic Gonadotropin – hCG)
    - Donne potenzialmente fertili, definite come tutte le donne fisiologicamente in grado di iniziare una gravidanza, a meno che non utilizzino metodi contraccettivi efficaci durante tutto lo studio o più a lungo se richiesto dalle informazioni per la prescrizione approvate a livello locale (ad es. 20 settimane dall’ultima dose di secukinumab nell’Unione Europea).
    Vedi protocollo per altri criteri di esclusione.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with a spinal pain
    NRS score below 4
    Proporzione di pazienti con un punteggio NRS per il dolore spinale < 4
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8
    Alla Settimana 8
    E.5.2Secondary end point(s)
    Proportion of patients with a Bath ankylosing spondylitis disease activity index score below 4
    Proporzione di pazienti con un punteggio BASDAI < 4
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 8
    Alla Settimana 8
    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 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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA93
    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 Information not present in EudraCT
    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
    Bulgaria
    Croatia
    Czechia
    Estonia
    Finland
    Germany
    Greece
    Ireland
    Israel
    Italy
    Latvia
    Lithuania
    Poland
    Romania
    Russian Federation
    Spain
    Sweden
    Switzerland
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 334
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 310
    F.4.2.2In the whole clinical trial 352
    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. Based on the individual risk/benefit profile of a patient, treatment options may include DMARDs. In case of a biologic treatment, a waiting period of 3 months before initiating the treatment is recommended.
    Il PI fornirà assistenza medica di follow-up per tutti i pazienti che si sono ritirati prematuramente dallo studio o deve indirizzarli ad un'adeguata cura medica.Questa può includere l'inizio di un altro trattamento al di fuori dello studio, come ritenuto opportuno dal PI. Sulla base del profilo individuale di rischio/beneficio di un paziente, le opzioni di trattamento possono includere DMARD. In caso di trattamento biologico è consigliabile un periodo di attesa di 3mesi prima del trattamento.
    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 Decision2017-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-19
    P. End of Trial
    P.End of Trial StatusCompleted
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    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.

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