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   43843   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:2015-003937-84
    Sponsor's Protocol Code Number:I1F-MC-RHBW
    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 number2015-003937-84
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled 16 Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in TNFi-Experienced Patients with Radiographic Axial Spondyloarthritis
    Studio Multicentrico, Randomizzato, in Doppio Cieco, Controllato verso Placebo di 16 Settimane Seguito da una Fase di Valutazione a Lungo Termine per l’Efficacia e la Sicurezza di Ixekizumab (LY2439821) in Pazienti con Spondiloartrite Assiale Radiografica che siano stati precedentemente trattati con anti-TNFa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Ixekizumab in Patients with Axial Spondyloarthritis who have Previously Taken Tumor Necrosis Factor Inhibitors for Their Condition.
    Uno studio con Ixekizumab in pazienti con Spondiloartrite Assiale che hanno precedentemente ricevuto anti-TNFa per la loro condizione.
    A.3.2Name or abbreviated title of the trial where available
    CoASt-W
    CoASt-W
    A.4.1Sponsor's protocol code numberI1F-MC-RHBW
    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 SponsorELI LILLY & COMPANY, LILLY CORPORATE CENTER
    B.1.3.4CountryUnited States
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number00390554257386
    B.5.5Fax number00390554257348
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 nameLY2439821
    D.3.2Product code [Ixekizumab]
    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 INNIxekizumab
    D.3.9.2Current sponsor codeLY2439821
    D.3.9.4EV Substance CodeSUB30469
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    Radiographic Axial Spondyloarthritis
    Spondiloartrite Assiale Radiografica
    E.1.1.1Medical condition in easily understood language
    A chronic inflammatory condition affecting the spine and sacroiliac joint. It is characterized by pain and stiffness of joints.
    Una condizione infiammatoria cronica che colpisce la colonna vertebrale e l'articolazione sacro-iliaca. Essa è caratterizzata da dolore e rigidità delle articolazioni.
    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 LLT
    E.1.2Classification code 10041672
    E.1.2Term Spondylitis ankylosing
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare both ixekizumab regimens (80 mg every 2 weeks or 80 mg every 4 weeks) vs placebo in tumor necrosis factor inhibitor (TNFi) experienced patients with active radiographic axial spondyloarthritis (r-axSpA) at Week 16.
    Confrontare entrambi i regimi terapeutici di Ixekizumab (80 mg ogni 2 settimane o 80 mg ogni 4 settimane) con il placebo in pazienti affetti da Spondiloartrite Assiale Radiografica (r-axSPA) trattati con anti-TNFa alla Settimana 16.
    E.2.2Secondary objectives of the trial
    To compare both ixekizumab regimens (80 mg every 2 weeks or 80 mg every 4 weeks) to placebo at Week 16 on signs and symptoms, function, mobility, and quality of life in TNFi experienced patients with r-axSpA.
    Confrontare entrambi i regimi terapeutici di Ixekizumab (80 mg ogni 2 settimane o 80 mg ogni 4 settimane) con il placebo alla Settimana 16 riguardo i segni e sintomi, la funzione, la capacità motoria, e la qualità della vita in pazienti affetti da Spondiloartrite Assiale Radiografica (r-axSPA) trattati con anti-TNFa.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: There is a MRI substudy that will be conducted in selected countries. Patients will have MRIs of the spine at screening and at Week 16. The MRI addendum version is 23Nov2015.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Vi è un sotto-studio per la Risonanza Magnetica che sarà condotto in Paesi selezionati. I pazienti effettueranno una Risonanza Magnetica della colonna vertebrale al momento dello screening e alla Settimana 16. La versione dell’addendum per la Risonanza Magnetica è 23-Novembre-2015.
    E.3Principal inclusion criteria
    -Are at least 18 years of age
    -Have an established diagnosis of radiographic axial spondyloarthritis (r-axSpA) with sacroiliitis defined radiographically according to the mNY criteria
    -Patients have a history of back pain =3 months with age at onset <45 years.
    -Have had prior treatment with at least 1 and not more than 2 TNF inhibitors.
    -Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs.
    -Have given written informed consent
    - Pazienti maggiorenni, almeno 18 anni;
    - Pazienti con una diagnosi confermata di Spondiloartrite Assiale Radiografica (r-axSpA) con sacroileite definita radiograficamente secondo i criteri di New York modificati (mNY);
    - Pazienti con una storia di dolore alla schiena =3 mesi con l’età di esordio ‹ 45 anni;
    - Trattamento precedente con almeno 1 e non più di 2 anti-TNFa;
    - Pazienti con un’inadeguata risposta a 2 o più Farmaci Antinfiammatori Non Steroidei (FANS) all’intervallo di dosaggio terapeutico per una durata totale di almeno 4 settimane OPPURE con una storia di intolleranza ai Farmaci Antinfiammatori Non Steroidei (FANS);
    - Pazienti che hanno firmato il modulo di Consenso Informato.
    E.4Principal exclusion criteria
    - Have total ankylosis of the spine
    -Have taken none or more than two tumor necrosis factor inhibitor medications
    - Have recently received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year.
    - Have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis
    - Have a compromised immune system.
    - Have any other serious and/or uncontrolled diseases.
    - Have either a current diagnosis or a recent history of malignant disease.
    - Have had Major surgery within 8 weeks of baseline, or will require surgery during the study
    - Are pregnant or breastfeeding
    - Pazienti con totale anchilosi della colonna vertebrale;
    - Non abbiano assunto nessun farmaco anti-TNFa oppure ne abbiano assunti più di due;
    - Abbiano ricevuto di recente un vaccino vivo entro le 12 settimane o abbiano effettuato una vaccinazione contro il bacillo di Calmette e Guérin nell’anno precedente;
    - Abbiano un’infezione in atto o con caratteristiche di serietà entro le 12 settimane precedenti o evidenza di tubercolosi attiva;
    - Abbiano un sistema immunitario compromesso;
    - Abbiano qualsiasi altra malattia grave e incontrollata;
    - Abbiano o una diagnosi attuale o una storia recente di malignità;
    - Abbiano subito interventi di chirurgia maggiore entro le 8 settimane dal baseline, o necessitino di subire interventi durante lo studio;
    - Siano in stato di gravidanza o in allattamento
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) response.
    Percentuale di pazienti che hanno raggiunto una risposta ASAS40 (Assessment of Spondiloarthritis International Society 40).
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 16
    settimana 16
    E.5.2Secondary end point(s)
    1) Proportion of patients achieving an ASAS20 response

    2) Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)

    3) Proportion of patients achieving Bath Ankylosing
    Spondylitis Disease Activity Index 50 (BASDAI50) response

    4) Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)

    5) Proportion of patients achieving ASDAS inactive disease

    6) Change from baseline in Short Form 36 (SF-36) physical component score (PCS)
    7) Change from baseline in ASAS Health Index (ASAS HI)

    8) Change from baseline in magnetic resonance imaging (MRI) of the spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI]
    Berlin score). (This endpoint applies to MRI addendum only).
    1) Percentuale di pazienti che hanno raggiunto una risposta ASAS20;

    2) Variazione rispetto al basale del punteggio ASDAS (Ankylosing Spondylitis Disease Activity Score);

    3) Percentuale di pazienti che hanno raggiunto una risposta BASDAI50 (Bath Ankylosing Spondylitis Functional Index);

    4) Variazione rispetto al basale dell’indice BASFI (Bath Ankylosing Spondylitis Functional Index);

    5) Percentuale di pazienti che hanno ottenuto la valutazione ASDAS di malattia inattiva;

    6) Variazione rispetto al basale del punteggio relativo alla componente fisica (PCS) del questionario SF-36 (Short Form 36);

    7) Variazioni rispetto al basale dell’indice ASAS sulla salute (ASAS HI);

    8) Variazione rispetto al basale della Risonanza Magnetica (RM) della colonna vertebrale (ASSpiMRI [Ankylosing Spondylitis Spinal Magnetic Resonance Imaging] – criteri di Berlino) (Questo endpoint si applica solo all’addendum RM).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16
    Settimana 16
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    Argentina
    Brazil
    Canada
    Finland
    France
    Germany
    Hungary
    Israel
    Italy
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Puerto Rico
    Spain
    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
    LVLS
    LVLS
    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 months0
    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 months0
    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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 179
    F.4.2.2In the whole clinical trial 300
    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)
    Patients that complete Study RHBW may be eligible to enroll into a long-term study (Study I1F-MC-RHBY) for up to 2 additional years. Patients that do not enroll into Study RHBY will complete the Post-Treatment Follow-Up Period in Study RHBW and resume standard of care treatment as prescribed by their physician.
    I pazienti che hanno completato la loro partecipazione allo Studio RHBW possono essere eleggibili per l’inclusione nello studio clinico a lungo termine (Studio I1F-MC-RHBY) per un massimo di ulteriori 2 anni.
    I pazienti che non saranno inseriti nello studio RHBY completeranno il periodo di “Follow-Up” post-trattamento per lo studio RHBW e riprenderanno la terapia standard come prescritto dal loro medico.
    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 Decision2016-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-15
    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-Thu Apr 18 06:01:42 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA