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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7263   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).

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    EudraCT Number:2013-005575-41
    Sponsor's Protocol Code Number:CAIN457F2320
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-01-30
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2013-005575-41
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis
    Randomizované, dvojitě zaslepené, placebem kontrolované, multicentrické klinické hodnocení fáze III hodnotící účinnost, bezpečnost a snášenlivost podkožně podávaného secukinumabu (150 mg), s úvodním intenzivnějším režimem podkožních nasycovacích dávek nebo bez něj, až po dobu 2 let, u pacientů s aktivní ankylozující spondylitidou
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitis
    Studie s 16týdenním hodnocením účinnosti a 2letým hodnocením bezpečnosti, snášenlivosti a účinnosti secukinumabu u pacientů s aktivní ankylozující spondylitidou
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberCAIN457F2320
    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 Services AG
    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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis s.r.o.
    B.5.2Functional name of contact pointInformační služba - klin. hodnocení
    B.5.3 Address:
    B.5.3.1Street AddressNa Pankráci 1724/129
    B.5.3.2Town/ cityPraha 4
    B.5.3.3Post code140 00
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+420225 775 207
    B.5.5Fax number+420225 775 205
    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. name COSENTYX
    D. 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Ankylozující spondylitida
    E.1.1.1Medical condition in easily understood language
    Bechterev syndrom, Marie-Strümpell disease
    Bechtěrevova choroba, Choroba Marie-Strümpell
    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 that the efficacy of secukinumab 150 mg at Week 16 with or without a loading regimen is superior to placebo based on the proportion of subjects achieving an ASAS20 (Assessment of SpondyloArthritis International Society criteria) response.
    E.2.2Secondary objectives of the trial
    -To demonstrate that the efficacy of secukinumab 150 mg s.c., with or without loading, at Week 16 is superior to placebo based on
    •the proportion of subjects achieving an ASAS40 response
    •the change from baseline of high sensitivity C-Reactive Protein (hsCRP)
    •the proportion of patients meeting the ASAS 5/6 response criteria
    •the change from baseline in total Bath Ankylosing Spondylitis Disease Activity (BASDAI)
    •the change from baseline in Short Form-36 Physical Component Summary (SF-36 PCS)
    •the change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL)
    -To demonstrate that the efficacy of secukinumab 150 mg s.c., with or without loading, at
    Week 4 is superior to placebo based on:
    •the proportion of subjects achieving an ASAS20 response
    •the proportion of subjects achieving an ASAS40 response
    - Overall safety and tolerability of secukinumab
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional Exploratory Biomarker (Pharmacogenetic/RNA Expression) Study.
    For original protocol dated 23-Oct-2014. Release date: 03-Nov-2014.

    Blood samples are used for the biomarker study: biomarker information from the samples will be used to study whether response to treatment with secukinumab, any potential side effects, or patient´s disorder are related to biomarkers. These samples will be used to study scientific questions related to secukinumab, or related indications, or development of drugs to treat ankylosing spondylitis or related indications.
    Podstudie farmakogenetiky a exprese RNA - volitelná součást základní části klinického hodnocení.
    Verze 1.0, Datum: 28. ledna 2015.

    Vzorky krve jsou použity pro podstudii biomarkerů: informace o biomarkerech ze vzorků bude využita k prostudování, zda odpověď na léčbu secukinumabem, potenciální nežádoucí účinky nebo onemocnění pacienta souvisí s biomarkery. Tyto vzorky budou použity ke studiu odborných odpovědí týkajících se secukinumabu nebo souvisejících indikací, nebo vývoje léků pro léčbu ankylozující spondylitidy či souvisejících indikací.
    E.3Principal inclusion criteria
    - Moderate to severe AS
    - Prior radiographic evidence according to the Modified NY Criteria (1984)
    - Inadequate response to NSAIDs
    Other protocol-definied inclusion criteria may apply.
    E.4Principal exclusion criteria
    - Pregnancy or lactation
    - On-going infectious or malignant process on a chest X-ray or MRI
    - Previous exposure to IL-17 or IL-17R targeting therapies
    - Previous exposure to any biological immunomodulating agent excluding TNF antagonists
    - Previous cell depleting therapy
    Other protocol-definied exclusion criteria may apply.
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of Spondyloarthritis International Society criteria, ASAS 20
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 weeks
    E.5.2Secondary end point(s)
    - ASAS 40 response (a)
    - Serum hsCRP (a)
    - ASAS 5/6 response (a)
    - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (a)
    - Short Form-36 Physical Compenent Summary (SF-36 PCS) health survey (a)
    - Ankylosing Spondylitis Quality of Life (ASQoL) (a)
    - Overall safety and tolerability (b)
    E.5.2.1Timepoint(s) of evaluation of this end point
    (a) 16 weeks
    (b) 112 weeks
    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 Yes
    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. 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA77
    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
    Czech Republic
    Russian Federation
    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
    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 months1
    E.8.9.1In the Member State concerned days0
    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 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: 16
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 297
    F.4.2.2In the whole clinical trial 350
    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 biologic treatment, a waiting period of 3 months before initiating the treatment is recommended.
    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 Decision2015-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-02
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