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    Summary
    EudraCT Number:2016-002634-69
    Sponsor's Protocol Code Number:I1F-MC-RHBY
    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:2021-05-25
    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 number2016-002634-69
    A.3Full title of the trial
    Protocol I1F-MC-RHBY
    A Multicenter, Long-Term Extension Study of 104 Weeks, Including a Double-Blind, Placebo-Controlled 40-Week Randomized Withdrawal-Retreatment Period, to Evaluate the Maintenance of Treatment Effect of Ixekizumab (LY2439821) in Patients with Axial Spondyloarthritis
    Studio Multicentrico di Estensione a Lungo Termine di 104 Settimane, Comprendente un Periodo Randomizzato in Doppio Cieco e Controllato verso Placebo di Interruzione/Ri-Trattamento, della durata di 40 Settimane, volto a valutare il Mantenimento dell’Effetto del Trattamento con Ixekizumab (LY2439821) in Pazienti affetti da Spondiloartrite Assiale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3, multicenter, long-term extension study of 104 weeks in patients with axial spondyloarthritis
    Studio di Fase 3, multicentrico, di estensione a lungo termine di 104 Settimane, in pazienti affetti da spondiloartrite assiale
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberI1F-MC-RHBY
    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 Yes
    D.2.1.1.1Trade name TALTZ
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    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 nameIxekizumab
    D.3.2Product code [LY2439821]
    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
    Axial Spondyloarthritis
    Spondiloartrite Assiale
    E.1.1.1Medical condition in easily understood language
    Chronic Inflammatory disease affecting the spine and sacroiliac joint. It is characterized by pain and stiffness of joints.
    Malattia infiammatoria cronica che colpisce la colonna vertebrale e l'articolazione sacro-iliaca. E' 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

    To evaluate in patients having achieved a state of sustained remission whether the ixekizumab treatment group is superior to the placebo group in maintaining response during the randomized-withdrawal period

    Valutare nei pazienti che hanno raggiunto uno stato di remissione prolungata la superiorità del gruppo di trattamento con ixekizumab rispetto al gruppo con placebo nel mantenere la risposta durante il periodo randomizzato di interruzione
    E.2.2Secondary objectives of the trial

    -To compare the combined ixekizumab treatment group to historical control for 2-year radiographic progression in spine in patients with active radiographic axSpA

    -To evaluate in patients having achieved a state of sustained remission whether the ixekizumab 80 mg every 2 weeks (Q2W) treatment group or ixekizumab 80 mg every 4 weeks (Q4W) treatment group is superior to placebo in maintaining response

    -To evaluate in patients having achieved a state of sustained remission whether the combined ixekizumab treatment group is superior to the placebo group in maintaining response after treatment withdrawal

    -To evaluate in patients having achieved a state of sustained remission whether the ixekizumab 80 mg Q2W treatment group or ixekizumab 80 mg Q4W treatment group is superior to placebo in maintaining response after treatment withdrawal

    - Confrontare il gruppo di trattamento combinato con ixekizumab con il controllo storico per progressione radiografica a 2 anni nella colonna vertebrale nei pazienti con axSpA radiografica attiva

    -Valutare nei pazienti che hanno raggiunto uno stato di remissione prolungata se il gruppo di trattamento con ixekizumab 80 mg ogni 2 settimane (Q2W) o il gruppo di trattamento con ixekizumab 80 mg ogni 4 settimane (Q4W) è superiore rispetto al placebo nel mantenere la risposta

    - Valutare nei pazienti che hanno raggiunto uno stato di remissione prolungata se il gruppo di trattamento combinato con ixekizumab è superiore rispetto al gruppo placebo nel mantenere la risposta dopo l’interruzione del trattamento

    - Valutare nei pazienti che hanno raggiunto uno stato di remissione prolungata se il gruppo di trattamento con ixekizumab 80 mg Q2W o il gruppo di trattamento con ixekizumab 80 mg Q4W è superiore rispetto al placebo nel mantenere la risposta dopo l’interruzione del trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria

    1.Have completed the final study visit in Study RHBV, RHBW, or RHBX. (Note: Patients from Study RHBX are not eligible if they permanently discontinued ixekizumab and were receiving a TNF inhibitor).

    2.Must agree to use a reliable method of birth control.

    3.Have given written informed consent.

    1. Hanno completato la visita finale dello studio RHBV, RHBW o RHBX. (Nota: i pazienti provenienti dallo studio RHBX non sono idonei alla partecipazione se hanno interrotto in modo permanente ixekizumab e stavano ricevendo un inibitore del TNF).

    2. Devono acconsentire a utilizzare un metodo di contraccezione affidabile.

    3. Hanno fornito il loro consenso informato per iscritto.
    E.4Principal exclusion criteria

    -Have significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous ixekizumab study that, in the opinion of the investigator, pose an unacceptable risk to the patient if investigational product continues to be administered.

    -Have a known hypersensitivity to ixekizumab or any component of this investigational product.

    -Had investigational product permanently discontinued during a previous ixekizumab study.

    -Had temporary investigational product interruption at any time during or at the final study visit of a previous ixekizumab study and, in the opinion of the investigator, restarting ixekizumab poses an unacceptable risk for the patient’s participation in the study.

    -Have any other condition that, in the opinion of the investigator, renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient from following and completing the protocol

    -Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

    - Soffrono di patologie o disturbi significativi non controllati di natura cerebro-cardiovascolare, respiratoria, epatica, renale, gastrointestinale, endocrina, ematologica o neuropsichiatrica oppure presentano anomalie nei parametri di laboratorio sviluppatesi nel corso di un precedente studio su ixekizumab che, a parere dello sperimentatore, rappresentano un rischio inaccettabile per il paziente se si continua con la somministrazione del prodotto sperimentale.

    - Hanno un’ipersensibilità nota verso ixekizumab o uno qualsiasi dei componenti di questo prodotto sperimentale.

    - Hanno interrotto in modo permanente l’assunzione del prodotto sperimentale durante uno studio precedente condotto su ixekizumab.

    - Hanno interrotto temporaneamente l’assunzione del prodotto sperimentale in qualsiasi momento nel corso di un precedente studio su ixekizumab o in occasione della visita finale e, secondo il parere dello sperimentatore, riprendere la somministrazione di ixekizumab rappresenta un rischio inaccettabile per la partecipazione del paziente allo studio.

    - Soffrono di un’altra condizione che, secondo il parere dello sperimentatore, rende il paziente incapace di comprendere la natura, la portata e le possibili conseguenze dello studio oppure impedisce al paziente di seguire e completare il protocollo.

    - Sono attualmente arruolati in un altro studio clinico che prevede l’impiego di un prodotto sperimentale o prendono parte a qualsiasi altro tipo di ricerca medica giudicata non compatibile con il presente studio da un punto di vista scientifico o medico.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients in the randomized withdrawal population who do not experience a flare during the randomized withdrawal retreatment period
    Percentuale di pazienti nella popolazione randomizzata all’interruzione che non presenta una riacutizzazione durante il periodo randomizzato di interruzione/ritrattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 64
    Settimana 64
    E.5.2Secondary end point(s)

    -Change in modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS score)

    -The proportion of patients in the randomized withdrawal population who do not experience a flare during the randomized withdrawalretreatment
    period

    -Time to flare during the randomized withdrawal-retreatment period

    - Variazione del punteggio mSASSS (modified Stoke Ankylosing Spondylitis Spinal Score)

    - Percentuale di pazienti nella popolazione randomizzata all’interruzione che non presenta una riacutizzazione durante il periodo randomizzato di interruzione/ritrattamento

    - Tempo alla riacutizzazione durante il periodo randomizzato di interruzione/ritrattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 104
    Settimana 104
    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 trial6
    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 EEA67
    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
    Brazil
    Canada
    Israel
    Japan
    Korea, Republic of
    Mexico
    Puerto Rico
    Russian Federation
    Taiwan
    United States
    Austria
    Finland
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Romania
    Spain
    United Kingdom
    Czechia
    Argentina
    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 years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 675
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 360
    F.4.2.2In the whole clinical trial 750
    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)
    Investigational product will not be made available to patients after conclusion of this study.
    Il prodotto sperimentale non sarà reso disponibile per i pazienti dopo la conclusione dello studio.
    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 Decision2017-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-19
    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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