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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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    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2014-000917-30
    Sponsor's Protocol Code Number:101MS207
    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:2014-07-07
    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 number2014-000917-30
    A.3Full title of the trial
    A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis
    Studio multicentrico, in aperto sull’immunogenicità e la sicurezza di Natalizumab 300 mg somministrato per via sottocutanea a soggetti con sclerosi multipla recidivante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis
    Studio sull’immunogenicità e sicurezza di Natalizumab (BG00002) somministrato a soggetti affetti da sclerosi multipla recidivante.
    A.4.1Sponsor's protocol code number101MS207
    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 pointN/A
    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.5.6E-mailclinicaltrials@biogenidec.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 nameNatalizumab for Subcutaneous Injection
    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 INNNATALIZUMAB
    D.3.9.1CAS number 189261-10-7
    D.3.9.4EV Substance CodeSUB22282
    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
    Multiple Sclerosis (MS)
    Sclerosi multipla (SM)
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis (MS)
    Sclerosi multipla (SM)
    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 17.0
    E.1.2Level PT
    E.1.2Classification code 10048393
    E.1.2Term Multiple sclerosis relapse
    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 this study is to evaluate the immunogenicity of natalizumab 300 mg SC administered to subjects with relapsing MS.
    L’obiettivo primario di questo studio è valutare l’immunogenicità di natalizumab 300 mg somministrato per via SC ai soggetti con RMS.
    E.2.2Secondary objectives of the trial
    The secondary objectives are as follows:

    • To evaluate the safety of natalizumab SC injections.

    • To evaluate the efficacy of natalizumab SC injections on relapses and on new MRI lesions.
    gli obiettivi secondari sono i seguenti:
    • Valutare la sicurezza delle iniezioni SC di natalizumab.
    • Valutare l’efficacia delle iniezioni SC di natalizumab in termini di recidive e nuove lesioni alla risonanza magnetica per immagini (RMI).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A pharmacogenomics study ("PGx study") is being done in connection with the main study and is being conducted as there is growing evidence that differences in people's genes known as DNA or RNA (genetic material) may cause differences in the way they respond to medicine. These differences in how a drug affects someone may be due to differences in peoples' genes and impact how the medicine works. These differences may also affect why some people get certain diseases and the way a person gets sick or gets better. Finally, studying genetic differences may lead to understanding why some people have unexpected reactions to medicines during a study.

    Subject participation in the PGx study is optional.
    è prevista l’esecuzione di un sottostudio di farmacogenomica il cui razionale è l’evidenza che, differenze a livello genetico negli individui, possono determinare una diversa risposta al farmaco. Queste differenze possono influenzare l’efficacia del farmaco sull’organismo o determinare l’isorgenza di patologie. Inoltre lo studio genetico può aiutare a comprendere perchè alcune persone presentano reazioni inattese al farmaco di studio. La partecipazione del soggetto al sottostudio è opzionale.
    E.3Principal inclusion criteria
    - Must have documented diagnosis of RMS at screening.
    - Must fall within the therapeutic indications stated in the locally approved label for natalizumab.
    - Must have an EDSS score from 0 to 6.5, inclusive.
    - documentata storia di sclerosi multipla recidivante allo screening
    - deve rientrare nell’indicazione terapeutica approvata per natalizumab
    - deve avere un ponteggio EDSS da 0 a 6.5 incluso.
    E.4Principal exclusion criteria
    - Any prior use of natalizumab.
    - Positive for anti-natalizumab antibodies at screening.
    - Treatment with immunomodulatory injections (including IFN-β and glatiramer acetate) within 2 weeks prior to Screening.
    - documentata storia di sclerosi multipla recidivante allo screening
    - deve rientrare nell’indicazione terapeutica approvata per natalizumab
    - deve avere un ponteggio EDSS da 0 a 6.5 incluso.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects with persistent anti-natalizumab antibodies over 48 weeks. Persistent anti-natalizumab antibodies are defined as 2 positive anti-natalizumab test results separated by at least 6 weeks, with at least 1 positive test result occurring at or after the Week 24 Visit.
    La percentuale di soggetti con anticorpi anti-natalizumab persistenti nelle 48 settimane. Gli anticorpi anti-natalizumab persistenti sono definiti come 2 risultati positivi all'esame anti-natalizumab a distanza di almeno 6 settimane, con almeno 1 risultato positivo all'esame in occasione o dopo la visita della Settimana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 settimane
    E.5.2Secondary end point(s)
    • The proportion of subjects with transient anti-natalizumab antibodies over 48 weeks.

    • The proportion of subjects with post-injection AEs including hypersensitivity reactions, anaphylactic reactions and other AEs occurring within 1 hour after subcutaneous natalizumab dosing.

    • The proportion of subjects with clinical relapse; or with new or enlarging T2 lesion(s), as determined by a central MRI reading center, over 48 weeks. Clinical relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Neurologist. The subject must have had objective signs on the neurologist’s examination that confirm the event.

    • The proportion of subjects with Gd-enhancing lesion(s), as determined by a central MRI reading center, over 48 weeks.

    • The proportion of subjects with AEs and SAEs.
    • La percentuale di soggetti con anticorpi anti-natalizumab transitori nelle 48 settimane.
    • La percentuale di soggetti con eventi avversi (EA) in seguito all’iniezione, tra cui reazioni di ipersensibilità, reazioni anafilattiche e altri EA manifestati entro 1 ora dalla somministrazione di natalizumab SC.
    • La percentuale di soggetti con recidiva clinica o con lesione(i) nuova(e) o ingrandita(e) in T2, come evidenziato dalla lettura centralizzata dell’MRI, nelle 48 settimane. La recidiva clinica è definita come nuovi o ricorrenti sintomi neurologici non associati a febbre o infezione, della durata di almeno 24 ore, e accompagnati da nuovi riscontri neurologici obiettivi in base al giudizio del neurologo. Il soggetto deve presentare segni obiettivi alla visita neurologica che confermino l’evento.
    • La percentuale di soggetti con lesione(i) captante(i) il gadolinio (Gd), come evidenziato dalla lettura centralizzata dell’MRI, nelle 48 settimane.
    • La percentuale di soggetti con EA ed eventi avversi seri (serious adverse events, SAE).
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 settimane
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.2.4Number of treatment arms in the trial1
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LSLV
    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 months10
    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 months10
    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: 113
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 113
    F.4.2.2In the whole clinical trial 113
    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 Decision2014-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-05-08
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