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    The EU Clinical Trials Register currently displays   41200   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-002820-10
    Sponsor's Protocol Code Number:205MS305
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-01-13
    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 number2016-002820-10
    A.3Full title of the trial
    A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN)
    Studio di fase 3b, in aperto, multicentrico, della durata di 12 mesi, per valutare l¿efficacia e la sicurezza di BIIB019, daclizumab, in soggetti affetti da sclerosi multipla recidivante remittente (SMRR) che effettuano il passaggio da natalizumab (SUSTAIN))
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Daclizumab in Participants with RRMS Switching from Natalizumab
    Efficacia e sicurezza di daclizumab in partecipanti con SMRR che passano
    da natalizumab
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and Safety of Daclizumab in Participants with RRMS Switching from Natalizumab
    Efficacia e sicurezza di daclizumab in partecipanti con SMRR che passano da natalizumab
    A.4.1Sponsor's protocol code number205MS305
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02881567
    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 SponsorBIOGEN IDEC RESEARCH LIMITED
    B.1.3.4CountryUnited Kingdom
    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 supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointSUSTAIN Clinical Trials Team
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0000
    B.5.5Fax number0000
    B.5.6E-mailclinicaltrials@biogen.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 Zinbryta
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Idec Limited
    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 nameDaclizumab
    D.3.2Product code BIIB019
    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 INNDACLIZUMAB
    D.3.9.2Current sponsor codeBIIB019
    D.3.9.3Other descriptive nameDAC HYP
    D.3.9.4EV Substance CodeSUB118955
    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.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Remitting-Relapsing Multiple Sclerosis
    sclerosi multipla recidivante remittente
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    Sclerosi multipla
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the effects of treatment with daclizumab on the proportion of participants relapse-free at 6 months in Relapsing-Remitting Multiple Sclerosis (RRMS) participants, who switched from treatment with natalizumab to daclizumab due to safety concerns.
    L¿obiettivo primario dello studio consiste nel valutare gli effetti del trattamento con daclizumab sulla percentuale di partecipanti che non mostrano recidive a 6 mesi tra i partecipanti affetti da sclerosi multipla recidivante remittente (SMRR), che sono passati dal trattamento con natalizumab a daclizumab permotivi di sicurezza.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study in this study population are to evaluate the effects of daclizumab on the following: 1) Multiple Sclerosis (MS) relapse activity including the annualized relapse rate (ARR) and the proportion of participants experiencing relapses requiring hospitalization and/or steroid treatment; 2) MS-related outcomes measured using magnetic resonance imaging (MRI); 3) Safety and tolerability in participants previously treated with natalizumab.
    Gli obiettivi secondari di questo studio in questa popolazione di studio consistono nel valutare gli effetti di daclizumab su quanto segue: 1) attivit¿ della recidiva di sclerosi multipla (SM), compresi il tasso annualizzato di recidiva (ARR) e la percentuale di partecipanti che manifestano recidive e necessitano di ricovero e/o trattamento steroideo; 2) esiti correlati alla SM misurati mediante risonanza magnetica (RMI); 3) sicurezza e tollerabilit¿ in partecipanti precedentemente trattati con natalizumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria
    1. Must have documented diagnosis of RRMS (McDonald 2010 Criteria) at screening [Polman 2011].
    2. Must have been treated with natalizumab for at least the 12 months prior to screening and have not missed 2 or more consecutive scheduled doses.
    3. Must be naïve to daclizumab and other forms of daclizumab such as Zenapax® prior to enrollment.
    4. Must have a confirmed Expanded Disability Status Scale (EDSS) score of 0 to 5.5, inclusive, at screening.
    5. Female participants of childbearing potential must practice effective contraception from Day -1 and be willing and able to continue contraception for duration of the study.

    NOTE: Other protocol defined Inclusion criteria may apply.

    1. I soggetti devono presentare una diagnosi documentata di SMRR (Criteri McDonald 2010) allo screening [Polman 2011].
    2. I soggetti devono essere stati trattati con natalizumab per almeno i 12 mesi precedenti lo screening e non devono aver saltato 2 o più dosi consecutive programmate.
    3. I soggetti devono essere naïve a daclizumab e altre forme di daclizumab quali Zenapax® prima dell’arruolamento.
    4. I soggetti devono avere un punteggio confermato sulla Scala di invalidità espansa (EDSS) compreso tra 0 e 5,5 (estremi compresi) allo screening.
    5. Le partecipanti in età fertile devono adottare metodi contraccettivi
    efficaci a partire dal Giorno -1 e devono essere disposte e in grado di continuare la contraccezione per tutta la durata dello studio.
    NOTA: possono essere applicati altri criteri di inclusione definiti dal protocollo.
    E.4Principal exclusion criteria
    Key Exclusion Criteria
    1. Current participation in another investigational study.
    2. Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold) [Lublin 2014].
    3. Females breastfeeding, pregnant, or planning to become pregnant; or women who have a positive pregnancy test result during screening.
    4. History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to screening.
    5. History of severe opportunistic infections (including progressive multifocal leukoencephalopathy (PML)) or any clinically significant, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
    6. Discontinued natalizumab due to suspicion of PML.
    7. Known active malignancies (participants with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible).
    8. The participant is using another MS therapy concomitantly.
    9. Known history of human immunodeficiency virus (HIV).
    10. Positive test result for Hepatitis C virus (test for hepatitis C virus antibody [HCV Ab]) or hepatitis B virus (test for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]).
    11. The participant has been treated with immunosuppressive or immunomodulating treatments including mitoxantrone, azathioprine, methotrexate, cyclophosphamide, or mycophenolate mofetil.

    NOTE: Other protocol defined Exclusion criteria may apply.

    1. Attuale partecipazione a un altro studio sperimentale.
    2. Diagnosi di SM primaria progressiva, secondaria progressiva o
    progressiva recidivante (definita secondo Lublin e Reingold) [Lublin
    2014].
    3. Soggetti di sesso femminile in allattamento, in gravidanza o che prevedano di iniziare una gravidanza; o donne che risultano positive al test di gravidanza durante lo screening.
    4. Anamnesi di abuso di alcol o sostanze stupefacenti (in base al giudizio dello Sperimentatore) nell’anno precedente lo screening.
    5. Anamnesi di infezioni opportunistiche gravi (compresa
    leucoencefalopatia multifocale progressiva [PML]) o qualsiasi malattia
    cardiaca, endocrinologica, ematologica, epatica, immunologica, metabolica, urologica, polmonare, neurologica (diversa da SM), dermatologica, psichiatrica e renale clinicamente significativa o qualsiasi altra grave malattia determinata dallo sperimentatore.
    6. Interruzione di natalizumab per sospetto di PML.
    7. Neoplasie maligne attive note (i partecipanti con carcinoma cutaneo
    basocellulare che è stato completamente escisso prima dello studio rimangono idonei).
    8. Il partecipante sta facendo uso di un’altra terapia concomitante per la SM.
    9. Anamnesi nota di infezione da virus dell’immunodeficienza umana (HIV).
    10. Risultato positivo al test per il virus dell’epatite C (test per l’anticorpo anti-virus dell’epatite C [HCV Ab] o virus dell’epatite B (test per l’antigene di superficie dell’epatite B [HBsAg] e/o anticorpo anti-core del virus dell’epatite B [HBcAb]).
    11. Il partecipante è stato trattato con terapie immunosoppressive o
    immunomodulanti compresi mitoxantrone, azatioprina,
    metotrexato, ciclofosfamide o micofenolato mofetile.
    NOTA: possono essere applicati altri criteri di esclusione definiti dal protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants relapse-free at Month 6 in RRMS participants
    Percentuale di partecipanti senza recidive al Mese 6 tra i partecipanti con SMRR
    E.5.1.1Timepoint(s) of evaluation of this end point
    Proportion of participants relapse-free at Month 6 in RRMS participants
    Percentuale di partecipanti senza recidive al Mese 6 tra i partecipanti con SMRR
    E.5.2Secondary end point(s)
    Proportion of participants relapse-free at Month 12. Proportion of participants experiencing relapse requiring hospitalization and/or steroid treatment at Month 12. Annualized relapse rate (ARR) at Month 12. Number of new gadolinium (Gd+) enhanced and T1 hypointense lesions at Month 6 on MRI. Number of new Gd+ enhanced and T1 hypointense lesions at Month 12 on MRI. Number of new or newly enlarged T2 hyperintense lesions at Month 6 on MRI. Number of new or newly enlarged T2 hyperintense lesions at Month 12 on MRI. Permanent discontinuation rate of daclizumab at Month 12. Number of participants that experience Adverse Events (AEs) or Serious Adverse Events (SAEs). Number of participants with clinical relevant shifts in laboratory assessments.
    Percentuale di partecipanti senza recidive al Mese 12.

    Percentuale di partecipanti che manifestano recidive e necessitano di ricovero e/o trattamento steroideo al Mese 12.

    Tasso annualizzato di recidiva (ARR) al Mese 12.

    Numero di nuove lesioni captanti il gadolinio (Gd+) e ipointense in T1 alla RMI al Mese 6.

    Numero di nuove lesioni captanti Gd+ e ipointense in T1 alla RMI al Mese 12.

    Numero di lesioni, nuove o di recente espansione, iperintense in T2 alla RMI al Mese 6.

    Numero di lesioni, nuove o di recente espansione, iperintense in T2 alla RMI al Mese 12

    Tasso di interruzione permanente di daclizumab al Mese 12.

    Numero di partecipanti che manifestano eventi avversi (EA) o eventi avversi gravi (SAE).

    Numero di partecipanti con variazioni clinicamente rilevanti nelle valutazioni di laboratorio.

    E.5.2.1Timepoint(s) of evaluation of this end point
    Proportion of participants relapse-free at Month 12. Proportion of participants experiencing relapse requiring hospitalization and/or steroid treatment at Month 12. Annualized relapse rate (ARR) at Month 12. Number of new gadolinium (Gd+) enhanced and T1 hypointense lesions at Month 6 on MRI. Number of new Gd+ enhanced and T1 hypointense lesions at Month 12 on MRI. Number of new or newly enlarged T2 hyperintense lesions at Month 6 on MRI. Number of new or newly enlarged T2 hyperintense lesions at Month 12 on MRI. Permanent discontinuation rate of daclizumab at Month 12. Number of participants that experience Adverse Events (AEs) or Serious Adverse Events (SAEs) up to 15 months. Number of participants with clinical relevant shifts in laboratory assessmentsup to 15 months.
    Percentuale di partecipanti senza recidive al Mese 12.
    Percentuale di partecipanti che manifestano recidive e necessitano di ricovero e/o trattamento steroideo al Mese 12.
    Tasso annualizzato di recidiva (ARR) al Mese 12.
    Numero di nuove lesioni captanti il gadolinio (Gd+) e ipointense in T1 alla RM al Mese 6.
    Numero di nuove lesioni captanti Gd+ e ipointense in T1 alla RMI al Mese 12.
    Numero di lesioni, nuove o di recente espansione, iperintense in T2 alla RMI al Mese 6.
    Numero di lesioni, nuove o di recente espansione, iperintense in T2 alla RMI al Mese 12.
    Tasso di interruzione permanente di daclizumab al Mese 12.
    Numero di partecipanti che manifestano eventi avversi (EA) o eventi avversi gravi (SAE) fino a 15 mesi.
    Numero di partecipanti con variazioni clinicamente rilevanti nelle valut
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Canada
    Denmark
    France
    Germany
    Italy
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 months6
    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 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: 100
    F.1.3Elderly (>=65 years) No
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 100
    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)
    None
    Nessuno
    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 Decision2017-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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