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    Summary
    EudraCT Number:2017-001224-22
    Sponsor's Protocol Code Number:215MS202
    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:2021-01-20
    Trial 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 number2017-001224-22
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies
    Uno studio multicentrico, randomizzato, in doppio cieco, controllato con placebo in soggetti con sclerosi multipla recidivante per valutare l’efficacia e la sicurezza di BIIB033 come terapia aggiuntiva alle terapie antinfiammatorie modificanti la malattia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)
    efficacia e la sicurezza di BIIB033 come terapia aggiuntiva alle terapie modificanti la malattia (DMT) nella sclerosi multipla recidivante (SMR).
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS
    efficacia e la sicurezza di BIIB033 come terapia aggiuntiva alle DMT nella SMR
    A.4.1Sponsor's protocol code number215MS202
    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 point215MS202 Clinical Trial 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 number0000000000000000
    B.5.5Fax number0000000000000000000
    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 No
    D.2.1.1.1Trade name N/A
    D.2.1.1.2Name of the Marketing Authorisation holderN/A
    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 nameOpicinumab
    D.3.2Product code [BIIB033]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOpicinumab
    D.3.9.2Current sponsor codeN/A
    D.3.9.4EV Substance CodeSUB118957
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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 Yes
    D.3.11.13.1Other medicinal product typefully human IgG1 agly anti-LINGO-1 monoclonalAntib
    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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple Sclerosis
    Sclerosi multipla
    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 10067063
    E.1.2Term Progressive relapsing multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    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
    To evaluate the efficacy and safety of BIIB033 used as add-on therapy to DMTs in subjects with relapsing multiple sclerosis (RMS).
    Valutare l’efficacia e la sicurezza di BIIB033 utilizzato come terapia aggiuntiva alle terapie modificanti la malattia (DMT) in soggetti affetti da sclerosi multipla recidivante (SMR).
    E.2.2Secondary objectives of the trial
    Evaluate effects of BIIB033 versus placebo on additional measures of disability improvement
    - Proportion of subjects with 12-week confirmed improvement in at least 1 of following assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND
    - Proportion of subjects with 12-week confirmed improvement in at least 1 of the following assessments: EDSS, T25FW, 9HPT-D, 9HPT-ND, or 3-Second Paced
    Auditory Serial Addition Test (PASAT-3)
    - Proportion of subjects with 12-week confirmed improvement in at least 1 of following assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND, and without
    confirmed worsening in any of 4 assessments during 72 weeks of study
    - Proportion of subjects with 12-week confirmed improvement in at least 1 of the following assessments: EDSS, T25FW, 9HPT-D, 9HPT-ND, and Symbol Digit
    Modalities Test (SDMT)
    - Proportion of subjects with 12-week confirmed improvement in at least 1 of following assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND (20% thresholds
    for T25FW and 9HPT)
    Valutare gli effetti di BIIB033 rispetto al placebo sulle misure aggiuntive del miglioramento della disabilità
    - Percentuale di soggetti con miglioramento confermato a 12 settimane in almeno 1 delle seguenti valutazioni: EDSS, T25FW, 9HPT-D o 9HPT-ND
    - Percentuale di soggetti con miglioramento confermato a 12 settimane in almeno 1 delle seguenti valutazioni: EDSS, T25FW, 9HPT-D, 9HPT-ND o Test uditivo di addizione seriale a intervalli di 3 secondi (PASAT-3)
    - Percentuale di soggetti con miglioramento confermato a 12 settimane in almeno 1 delle seguenti valutazioni: EDSS, T25FW, 9HPT-D o 9HPT-ND e senza peggioramento confermato in nessuna delle 4 valutazioni durante le 72 settimane dello studio
    - Percentuale di soggetti con miglioramento confermato a 12 settimane in almeno 1 delle seguenti valutazioni: EDSS, T25FW, 9HPT-D, 9HPT-ND e Test delle modalità dei simboli e delle cifre (SDMT)
    - Percentuale di soggetti con miglioramento confermato a 12 settimane in almeno 1 delle seguenti valuta
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    -Baseline Expanded Disability Status Scale (EDSS) of 2.0 to 6.0, have a diagnosis of relapsing-remitting multiple sclerosis (RRMS) per the 2010 McDonald’s criteria or onset of secondary progressive multiple sclerosis (SPMS) per the Lublin and Reingold criteria, and should have experienced their first MS symptom(s) within the previous 20 years.
    -Subjects must have experienced at least 1 of the following within 24 months prior to Day 1/Baseline: a clinical relapse (but not within 24 weeks prior to Day 1/Baseline), gadolinium-enhancing lesions on brain or spinal cord magnetic resonance imaging (MRI), or new T2 lesion(s) on brain or spinal cord MRI.
    -Subjects must be on a stable dose of a protocolspecified anti-inflammatory disease-modifying therapies
    (DMT) (IFNß [Avonex, Plegridy, Betaferon/Betaseron, or Rebif], dimethyl fumarate (DMF) [Tecfidera], or
    natalizumab [Tysabri]) for at least 24 weeks prior to enrollment.
    -In addition, subjects must have met protocol-defined MRI characteristics consistent with the presence of demyelination and relatively well-preserved tissue integrity. For enrollment, subjects must meet the following MRI criteria on the Screening/Baseline brain MRI: magnetization transfer ratio (MTR) in T2 lesions =-0.17 normalized MTR unit and diffusion tensor imaging (DTI) – radial diffusivity in T2 lesions =0.98 × 10-3 mm2/s
    - Punteggio al basale della Scala espansa dello stato di disabilità (EDSS) da 2,0 a 6,0, diagnosi di sclerosi multipla recidivante-remittente (SMRR) in base ai criteri di McDonald del 2010 o insorgenza di sclerosi multipla secondariamente progressiva (SMSP) in base ai criteri di Lublin e Reingold e insorgenza del/i primo/i sintomo/i di SM nei 20 anni precedenti.
    - I soggetti devono aver manifestato almeno 1 delle seguenti nei 24 mesi precedenti il Giorno 1/Basale: una recidiva clinica (ma non nelle 24 settimane precedenti il Giorno 1/Basale), lesioni captanti gadolinio alla risonanza magnetica (RM) cerebrale o del midollo spinale oppure una o più nuove lesioni in T2 alla RM cerebrale o del midollo spinale.
    - I soggetti devono essere in trattamento con dosi stabili di una delle terapie antinfiammatorie modificanti la malattia (DMT) specificate dal protocollo (IFNß [Avonex, Plegridy, Betaferon/Betaseron o Rebif], dimetilfumarato (DMF) [Tecfidera] o natalizumab [Tysabri]) da almeno 24 settimane prima dell’arruolamento.
    - Inoltre, i soggetti devono aver soddisfatto le caratteristiche di RM definite dal protocollo coerenti con la presenza di demielinizzazione e integrità tissutale relativamente ben preservata. Per l’arruolamento, i soggetti devono soddisfare i seguenti criteri di RM alla RM cerebrale dello Screening/Basale: rapporto di trasferimento di magnetizzazione (MTR) nelle lesioni in T2 =-0,17 unità MTR normalizzate e diffusività radiale nelle lesioni in T2 misurata all’imaging con tensore di diffusione (DTI) di =0,98 × 10-3 mm2/s
    E.4Principal exclusion criteria
    Key Exclusion Criteria
    -Primary progressive MS
    -An MS relapse that has occurred within 24 weeks prior to Day 1/Baseline or the subject has not stabilized from a previous relapse at the time of Screening.
    -Treatment with any chemotherapeutic agents (e.g., mitoxantrone, cyclophosphamide, cladribine), celldepleting
    monoclonal antibodies (mAbs) (e.g., rituximab, ocrelizumab, alemtuzumab), total lymphoid irradiation, T-cell or T-cell receptor vaccination, or teriflunomide within 1 year prior to Day 1/Baseline.
    -Treatment with other anti-inflammatory DMTs (e.g., GA, fingolimod, daclizumab) or plasmapheresis within 24 weeks prior to Day1/Baseline.
    -Treatment with Botox for limb spasticity within 24 weeks before Day 1/Baseline.
    -Contraindications to MRI, for example, presence of pacemakers or other implanted metal devices (excluding dental braces), an allergy to gadolinium renal impairment, or claustrophobia that cannot be medically managed.
    -History of human immunodeficiency virus or other immunodeficient conditions.
    -History of malignancy; however, subjects with a history of excised or treated basal cell carcinoma or fewer than 3 squamous cell carcinomas are eligible to participate in this study.
    - SM primariamente progressiva
    - Una recidiva di SM verificatasi nelle 24 settimane precedenti il Giorno 1/Basale oppure soggetto non stabilizzatosi da una precedente recidiva al momento dello Screening.
    - Trattamento con qualsiasi agente chemioterapico (es. mitoxantrone, ciclofosfamide, cladribina), anticorpo monoclonale (mAb) causante deplezione cellulare (es. rituximab, ocrelizumab, alemtuzumab), irradiazione linfoide totale, vaccinazione con cellule T o recettori delle cellule T o teriflunomide nell’anno precedente il Giorno 1/Basale.
    - Trattamento con altre DMT antinfiammatorie (es. GA, fingolimod, daclizumab) o plasmaferesi nelle 24 settimane precedenti il Giorno 1/Basale.
    - Trattamento con Botox per la spasticità degli arti nelle 24 settimane precedenti il Giorno 1/Basale.
    - Controindicazioni alla RM, per esempio presenza di pacemaker o di altri dispositivi impiantati di metallo (apparecchi ortodontici esclusi), allergia al gadolinio, insufficienza renale o claustrofobia non clinicamente gestibile.
    - Anamnesi di infezione da virus dell’immunodeficienza umana o altre condizioni di immunodeficienza.
    - Anamnesi di neoplasie maligne; sono comunque idonei a partecipare al presente studio i soggetti con anamnesi di carcinoma a cellule basali escisso o trattato o con meno di 3 carcinomi a cellule squamose.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response Score Overall Response Score is a multicomponent score based on 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the nondominant hand (9HPTND). It assesses overall changes in disability over time. Overall Score ranges from +4 to -4. At each visit, each component is given a score relative to baseline: -1 if threshold is met for worsening, 0 if no changes meet threshold criteria, or +1 if threshold is met for improvement. The thresholds for T25FW and 9HPT are defined by a 15% change from baseline (=15% decrease from baseline for improvement and =15% increase from baseline for worsening). For EDSS, improvement is defined as a =1.0-point decrease in EDSS from a baseline score of =6.0, and worsening is defined as a =1-point increase from a baseline score of =5.5 or a =0.5-point increase from a baseline score equal to 6.0.
    Il Punteggio di risposta complessiva è un punteggio a più componenti basato su 4 componenti: Scala espansa dello stato di disabilità (EDSS), Test del cammino cronometrato di 7,6 metri (T25FW), Test dei 9 pioli nella mano dominante (9HPT-D) e 9HPT nella mano non dominante (9HPT-ND). Consente di valutare l’evoluzione complessiva della disabilità fisica nel corso del tempo. Il punteggio complessivo va da +4 a -4. Ad ogni visita, a ciascun componente viene assegnato un punteggio rispetto al basale: -1 (se viene raggiunta la soglia di peggioramento), 0 (nessuna variazione che soddisfi i criteri soglia) o +1 (se viene raggiunta la soglia di miglioramento). Le soglie per il T25FW e il 9HPT-D sono definite da una variazione del 15% rispetto al basale (riduzione =15% rispetto al basale per il miglioramento e aumento =15% rispetto al basale per il peggioramento). Per l’EDSS, il miglioramento è definito come una riduzione =1,0 punto nell’EDSS rispetto a un punteggio basale di =6,0, mentre il peggioramento è definito come un incremento =1 punto rispetto a un punteggio basale =5,5 o un incremento =0,5 punti rispetto a un punteggio basale pari a 6,0.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessed every 12 weeks from Baseline to Week 72
    Valutato ogni 12 settimane dalla Baseline alla Settimana 72
    E.5.2Secondary end point(s)

    - Percentage of Participants with 12-week Confirmed Improvement in at least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND - Percentage of Participants with 12-week Confirmed Improvement in at least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, 9HPT-ND, or 3-Second Paced Auditory Serial Addition Test (PASAT-3) - Percentage of Participants with 12-week Confirmed Improvement in at least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND, and without confirmed worsening in any of the 4 assessments during the 72 weeks of the study - Percentage of Participants with 12-week Confirmed Improvement in at least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, 9HPT-ND, and Symbol Digit Modalities Test (SDMT) - Percentage of Participants with 12-week Confirmed Improvement in at least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND (20% thresholds for T25FW and 9HPT)
    - Percentuale di partecipanti con miglioramento confermato a 12 settimane in almeno 1 delle seguenti valutazioni: EDSS, T25FW, 9HPT-D o 9HPT-ND
    - Percentuale di partecipanti con miglioramento confermato a 12 settimane in almeno 1 delle seguenti valutazioni: EDSS, T25FW, 9HPT-D, 9HPT-ND o Test uditivo di addizione seriale a intervalli di 3 secondi (PASAT-3)
    - Percentuale di partecipanti con miglioramento confermato a 12 settimane in almeno 1 delle seguenti valutazioni: EDSS, T25FW, 9HPT-D o 9HPT-ND e senza peggioramento confermato in nessuna delle 4 valutazioni durante le 72 settimane dello studio
    - Percentuale di partecipanti con miglioramento confermato a 12 settimane in almeno 1 delle seguenti valutazioni: EDSS, T25FW, 9HPT-D, 9HPT-ND e Test delle modalità dei simboli e delle cifre (SDMT)
    - Percentuale di partecipanti con miglioramento confermato a 12 settimane in almeno 1 delle seguenti valutazioni: EDSS, T25FW, 9HPT-D o 9HPT-ND (soglie del 20% per il T25FW e il 9HPT)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessed every 12 weeks from Baseline to Week 72
    valutato ogni 12 settimane dalla baseline alla settimana 72
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 Yes
    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 trial2
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA84
    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
    Belgium
    Canada
    Czechia
    France
    Germany
    Israel
    Italy
    Netherlands
    Poland
    Spain
    Sweden
    Switzerland
    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 years3
    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 years3
    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: 240
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 117
    F.4.2.2In the whole clinical trial 240
    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 Decision2018-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-12-23
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