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    Summary
    EudraCT Number:2017-002631-42
    Sponsor's Protocol Code Number:MS700568_0022
    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:2021-06-17
    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 number2017-002631-42
    A.3Full title of the trial
    A 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis
    Studio prospettico della durata di 2 anni per valutare l’inizio dell’azione di Mavenclad® in soggetti con sclerosi multipla recidivante altamente attiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Research Study for People with Relapsing Multiple Sclerosis
    Studio clinico per persone con sclerosi multipla recidivante
    A.3.2Name or abbreviated title of the trial where available
    .
    .
    A.4.1Sponsor's protocol code numberMS700568_0022
    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 SponsorMERCK KGAA
    B.1.3.4CountryGermany
    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 supportMerck KgaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KgaA
    B.5.2Functional name of contact pointCommunication Center Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Strasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number00496151725200
    B.5.5Fax number00496151725200
    B.5.6E-mailservice@merckgroup.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 Mavenclad®
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono Europe Limited
    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 nameMavenclad
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLADRIBINA
    D.3.9.1CAS number 4291-63-8
    D.3.9.2Current sponsor codeEMD280922
    D.3.9.3Other descriptive name2-chloro-2'-deoxyadenosine (2-CdA)
    D.3.9.4EV Substance CodeSUB06635MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    Relapsing multiple sclerosis
    Sclerosi multipla recidivante
    E.1.1.1Medical condition in easily understood language
    Relapsing multiple sclerosis
    Sclerosi multipla recidivante
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term 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
    To determine the onset of action of Mavenclad®in subjects with highly active relapsing multiple sclerosis (RMS).
    Determinare l’inizio dell’azione di Mavenclad® in soggetti con sclerosi multipla recidivante (RMS) altamente attiva.
    E.2.2Secondary objectives of the trial
    To assess the effect of Mavenclad® on different immune system composites in particular cell subtypes count and repopulation.
    Valutare l’effetto di Mavenclad® su diversi compositi del sistema immunitario nella conta e nel ripopolamento di particolari sottotipi cellulari.
    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: 1- OCT Substudy : This sub-study explores the concept of using OCT as a structural biomarker of disease development in MS patients. The goal of
    this exploratory sub-study is to investigate the axonal degeneration in subjects enrolled into the trial, by measuring the RNFL thickness with OCT.
    2- DTI and fMRI Sub-study: This sub-study explores the concept of using DTI and fMRI as a structural biomarker of disease that are specific for brain tissue injury and repair.
    The goal of this exploratory sub-study is to investigate the brain structural and functional changes in subjects enrolled into the trial, by measuring DTI and fMRI over time.
    3 CSF Biomarker Sub-study: Validated biomarkers will help to define an optimal cladribine treatment response in MS and thus be of considerable
    value for taking treatment decisions and ensuring continued benefit from cladribine therapy. The candidate biomarkers have been selected
    on basis of evidences from literature.
    The goal of this exploratory sub-study is to investigate the surrogate marker in subjects enrolled into the trial, by measuring CSF biomarkers over time.
    4- Blood Biomarker Sub-study
    The goal of this exploratory sub-study is to investigate the surrogate marker in patients enrolled into the trial, by measuring blood biomarkers over time.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: 1 - Sottostudio di tomografia ottica computerizzata OCT: questo sottostudio esplora il concetto dell’utilizzo di OCT come biomarker strutturale dello sviluppo della malattia nei pazienti affetti da SM. L’obiettivo di questo sottostudio esplorativo è di valutare la degenerazione assonale nei soggetti arruolati nella sperimentazione, misurando lo spessore dello strato di fibre nervose retiniche [RNFL] – spessore maculare con OCT.
    2- Sottostudio di imaging con tensore di diffusione (DTI) e RMI funzionale (fMRI): questo sottostudio esplora il concetto dell’utilizzo di DTI e fMRI come biomarker strutturali della malattia che sono specifici per le lesioni cerebrali e la riparazione.
    L’obiettivo di questo sottostudio esplorativo è di studiare i cambiamenti strutturali e funzionali a livello cerebrale nei soggetti arruolati nella sperimentazione, con valutazioni di DTI e fMRI ripetute nel tempo.
    3. Sottostudio sui biomarcatori dell’LCS (liquido cerebrospinale): Biomarkers validati aiuteranno a definire la risposta ottimale per la SM al trattamento con cladribina e saranno quindi di considerevole valore per prendere decisioni relative al trattamento e per assicurare il continuo beneficio della terapia con la cladribina. I biomarkers candidati sono stati selezionati sulla base di evidenze dalla letteratura.
    4. Sottostudio sui biomarcatori del sangue:
    L’obiettivo di questo sottostudio esplorativo è di studiare i marker surrogati nei pazienti arruolati nella sperimentazione.
    E.3Principal inclusion criteria
    •Male or female subjects = 18 years old
    •Highly active RMS as defined by:
    -One relapse in the previous year and at least 1 T1 Gd+ lesion or 9 or more T2 lesions, while on therapy with other disease modifying drugs (DMDs)
    -Two or more relapses in the previous year, whether on DMD treatment or not
    •EDSS score =5.0
    •Soggetti di sesso maschile o femminile = 18 anni di età
    • RMS altamente attiva come definita da:
    - Una recidiva nell’anno precedente e almeno 1 lesione in T1 visibile con gadolinio (Gd+) o 9 o più lesioni in T2, durante la terapia con altri farmaci modificanti la malattia (DMD)
    - Due o più recidive nell’anno precedente, durante il trattamento con DMD o al di fuori dello stesso
    •Punteggio EDSS =5,0
    E.4Principal exclusion criteria
    •Previous exposure to drugs such as fingolimod, natalizumab, alemtuzumab, mitoxantrone and ocrelizumab
    •Positive test for hepatitis C or positive tests for hepatitis B infection: either hepatitis B surface antigen (HBsAg) positive, or positive hepatitis B core antibody (total anti HBcAb) confirmed by a positive viral polymerase chain reaction (PCR)
    •Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result
    •Currently receiving immunosuppressive or myelosuppressive therapy with, e.g., monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids
    •History of tuberculosis , presence of active tuberculosis, or latent tuberculosis
    •Presence of signs of PML detected by MRI, clinical and/or biomarker evaluations
    •Active malignancy
    • lymphocyte count not within normal limits of the local hospital lab before initiation of first treatment course
    •Precedente esposizione a farmaci quali fingolimod, natalizumab, alemtuzumab, mitoxantrone e ocrelizumab
    •Test positivo per l’epatite C o test positivi per l’infezione da epatite B: o positivo per l’antigene di superficie dell’epatite B (HBsAg), o positivo per l’anticorpo core dell’epatite B (anti-HBcAb totale) confermato da una reazione a catena della polimerasi (PCR) virale positiva
    •Anamnesi corrente o precedente di disturbi da immunodeficienza, incluso esito positivo al test del virus di immunodeficienza umana (HIV)
    •Attuale terapia immunosoppressiva o mielosoppressiva, per es. con anticorpi monoclonali, metotressato, ciclofosfamide, ciclosporina o azatioprina oppure uso cronico di corticosteroidi
    •Anamnesi di tubercolosi, presenza di tubercolosi attiva o latente
    • Presenza di segni di leucoencefalopatia multifocale progressiva (LMP) rilevati alla RMI, valutazioni cliniche e/o dei biomarcatori
    • Malignità attiva
    • conta dei linfociti al di fuori dei limiti normali del laboratorio ospedaliero locale prima dell'inizio del primo ciclo di trattamento.
    E.5 End points
    E.5.1Primary end point(s)
    Difference in the counts of combined unique active (CUA) MRI lesions during the first 6 months (i.e. during periods months 1-6, 2-6, 3-6) compared to baseline (i.e. the period screening to baseline).
    Differenza nella conta di lesioni attive uniche combinate (CUA) rilevabili all’RMI durante i primi 6 mesi (ovvero, durante i periodi dei mesi 1-6, 2-6, 3-6) rispetto al basale (ovvero, il periodo dallo screening al basale)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of 6 months compared to baseline
    Al termine dei 6 mesi rispetto al basale
    E.5.2Secondary end point(s)
    Characterization of immune cell subsets count
    Caratterizzazione della conta di sottogruppi di cellule immunitarie
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of 3, 6, 12, 15, 18 and 24 months compared to baseline
    Al termine dei 3, 6, 12, 15, 18 e 24 mesi rispetto al basale
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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
    Australia
    Canada
    Israel
    Austria
    Belgium
    Denmark
    Finland
    France
    Germany
    Hungary
    Ireland
    Italy
    Netherlands
    Norway
    Poland
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    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
    The end of the trial is defined as the last subject’s End of Trial visit.
    La conclusione della sperimentazione è definita come la Visita di Fine Studio dell'ultimo soggetto.
    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 months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 265
    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)
    Upon completion of study, subjects will be offered the opportunity of enrolling into an Extension study for a further 2 years (i.e., until 4 years from first treatment year course). A separate protocol will be followed for the Extension study.
    Patients who will not roll over to the extension study will return to their standard of care treatment.
    Alla fine della sperimentazione sarà offerta ai pazienti la possibilità di partecipare a uno studio di Estensione per ulteriori 2 anni di trattamento (cioè fino a 4 anni dal primo anno di trattamento). Seguirà un protocollo separato per lo studio di estensione.I pazienti che non passeranno a questo studio di estensione torneranno al trattamento standard.
    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 Decision2018-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-16
    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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