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    Summary
    EudraCT Number:2019-004857-10
    Sponsor's Protocol Code Number:GN41851
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 number2019-004857-10
    A.3Full title of the trial
    A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH TERIFLUNOMIDE IN ADULT PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS
    STUDIO DI FASE III, MULTICENTRICO, RANDOMIZZATO, IN DOPPIO CIECO, IN DOPPIO PLACEBO, A GRUPPI PARALLELI PER LA VALUTAZIONE DELL'EFFICACIA E DELLA SICUREZZA DI FENEBRUTINIB A CONFRONTO CON TERIFLUNOMIDE IN PAZIENTI ADULTI AFFETTI DA SCLEROSI MULTIPLA RECIDIVANTE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis
    Questo studio valuterà l'efficacia e la sicurezza di fenebrutinib a confronto con teriflunomide in pazienti adulti affetti da sclerosi multipla recidivante (SMR). Verrà inoltre valutata la farmacocinetica (PK) di fenebrutinib.
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberGN41851
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    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 supportGenentech Inc. c/o F. Hoffman-La Roche Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0000000
    B.5.5Fax number0000000
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 namefenebrutinib
    D.3.2Product code [RO7010939]
    D.3.4Pharmaceutical form Film-coated 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 INNFENEBRUTINIB
    D.3.9.2Current sponsor codeRO7010939
    D.3.9.4EV Substance CodeSUB190378
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Aubagio
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Groupe-EU/1/13/838/001, 002, 003, 004, 005
    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 nameTeriflunomide
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNTERIFLUNOMIDE
    D.3.9.1CAS number 108605-62-5
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB25218
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number14
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing multiple sclerosis (RMS)
    Sclerosi multipla recidivante (SMR)
    E.1.1.1Medical condition in easily understood language
    In RMS, the central nervous system, which includes the brain and spinal cord, becomes damaged. MS causes the immune system to attack the myelin, which is the insulation protecting the nerves
    Nella SMR,il sistema nervoso centrale,che comprende il cervello e il midollo spinale, viene danneggiato.La SM fa sì che il sistema immunitario attacchi la mielina,che è l'isolante che protegge i nervi
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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
    • To evaluate the efficacy of fenebrutinib compared with teriflunomide on the basis of time to onset of composite 12-week confirmed disability progression (cCDP12) and annualized relapse rate (ARR) in adult patients with RRMS and active secondary progressive MS, collectively referred to as RMS
    Valutare l'efficacia di fenebrutinib a confronto con teriflunomide, sulla base del tempo all'insorgenza di progressione della disabilità confermata composita a 12 settimane (cCDP12), e il tasso annualizzato di recidive (ARR).
    in pazienti adulti con SMRR e SM secondaria progressiva attiva, collettivamente denominati SMR
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of fenebrutinib treatment compared with teriflunomide on the basis of time to onset of composite 24-week confirmed composite disability progression (cCDP24), 12-week confirmed disability progression (CDP12), CDP24, total number of T1Gd+ lesions as detected by MRI, total number of new and/or enlarging T2-weighted lesions as detected by MRI, rate of percent change in total brain volume from Week 24 as assessed by MRI, rate of change from baseline in patient-reported physical impacts of MS, time to onset of 12-week confirmed 4-point worsening in Symbol Digit Modalities Test (SDMT) score, change from baseline to Week 48 in the concentration of serum neurofilament light chain (NfL)
    • To evaluate the safety of fenebrutinib compared with teriflunomide
    • To characterize the fenebrutinib pharmacokinetics profile
    •Valutare l'efficacia di fenebrutinib a confronto con teriflunomide, sulla base del tempo all'insorgenza di progressione di disabilità confermata composita a 24 settimane(cCDP24) Tempo all'insorgenza di CDP12,Tempo all'insorgenza di CDP a 24 settimane CDP24,numero totale di lesioni evidenziate da gadolinio sulla RM pesata in T1 (T1Gd+), come rilevato dalla RM,numero totale di lesioni pesate in T2 di nuova insorgenza e/o in allargamento rilevate dalla RM,Tasso di variazione % del volume tot del cervello dalla settimana 24, come valutato dalla RM,tasso di variazione dal basale degli impatti fisici della SM,Tempo all'insorgenza di peggioramento confermato di 4 punti a 12 settimane nel punteggio del test di modalità di digitazione di simboli (SDMT),variazione dal basale alla settimana 48 nella concentrazione della catena leggera del neurofilamento (NfL) nel siero.
    •valutare la sicurezza di fenebrutinib a confronto con teriflunomide
    •caratterizzazione il profilo PK di fenebrutinib
    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: CSF BIOMARKER SUBSTUDY ASSOCIATED WITH A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY (GN41851) TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH TERIFLUNOMIDE IN ADULT PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: SOTTOSTUDIO SUI BIOMARCATORI NEL LIQUIDO CEREBROSPINALE, ASSOCIATO A UNO STUDIO DI FASE III, MULTICENTRICO, RANDOMIZZATO, IN DOPPIO CIECO, IN DOPPIO PLACEBO, A GRUPPI PARALLELI (GN41851) PER LA VALUTAZIONE DELL'EFFICACIA E DELLA SICUREZZA DI FENEBRUTINIB A CONFRONTO CON TERIFLUNOMIDE IN PAZIENTI ADULTI AFFETTI DA SCLEROSI MULTIPLA RECIDIVANTE
    E.3Principal inclusion criteria
    • Age 18-55 years
    • Expanded Disability Status Scale score (EDSS) of 0.0-5.5 at screening
    • A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria
    • Neurologically stable for at least 30 days prior to randomization and baseline assessments
    • Ability to complete the 9-HPT for each hand in < 240 seconds
    • Ability to perform the timed 25-Foot Walk Test
    • For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs, women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period, for 8 weeks after the final dose of study medication, and until the teriflunomide elimination protocol is completed
    • For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, with a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment phase, for 8 weeks after the final dose of study drug, and until completion of the teriflunomide elimination protocol. Men must also refrain from donating sperm during this same period
    OLE Inclusion Criteria:
    • Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the opinion of the investigator, may benefit from treatment with fenebrutinib.
    • Patients randomized to the teriflunomide treatment arm during the DBT phase must undergo the ATEP prior to the first administration of open-label fenebrutinib
    • For female participants of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs, women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period, the OLE treatment phase and for 28 days after the final dose of open-label fenebrutinib. Women must also refrain from donating eggs during this same period
    • For male participants: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, with a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment phase, OLE treatment phase and for 28 days after the final dose of open-label fenebrutinib to avoid exposing the embryo. Men must also refrain from donating sperm during this same period
    •Età 18-55 anni
    •Punteggio EDSS 0-5,5 allo screening
    •Diagnosi di SMR* in base ai criteri di McDonald rivisti nel 2017
    •Stabilità neurologica per almeno 30 gg prima della randomizzazione e delle valutazioni basali
    •Capacità di eseguire il 9-HPT con ciascuna mano in <240 sec
    •Capacità di eseguire il T25FWT
    •Le donne devono rimanere astinenti o utilizzare metodi contraccettivi con un tasso di insuccesso <1% all'anno durante il periodo di trattamento, per 8 settimane dopo la dose finale di farmaco dello studio e fino al completamento della procedura di eliminazione di teriflunomide.Devono astenersi dalla donazione di ovociti durante questo stesso periodo
    •Gli uomini devono rimanere astinenti o utilizzare il preservativo durante la fase di trattamento, per 8 settimane dopo la dose finale di farmaco dello studio e fino al completamento della procedura di eliminazione di teriflunomide.Devono inoltre astenersi dalla donazione di sperma durante questo stesso periodo
    Criteri di inclusione OLE:
    •Pazienti che hanno completato la fase di DBT dello studio (continuando il trattamento dello studio; nessuna somministrazione di altra DMT) e che, secondo il parere dello sperimentatore, potrebbero trarre beneficio dal trattamento con fenebrutinib Pazienti che hanno completato la fase di DBT dello studio e che, secondo il parere dello sperimentatore, potrebbero trarre beneficio dal trattamento con fenebrutinib
    • pazienti randomizzati al braccio di trattamento con teriflunomide durante la fase di DBT devono essere sottoposti all'ATEP prima della prima somministrazione di fenebrutinib in aperto
    • Le donne devono praticare l'astinenza o utilizzare metodi contraccettivi che determinino un tasso di insuccesso ¿1% all'anno, durante la fase di trattamento di OLE e per 28 giorni dopo la dose finale di fenebrutinib in aperto. Le donne devono inoltre astenersi dalla donazione di ovociti durante questo stesso periodo
    •Gli uomini devono praticare l'astinenza o utilizzare il preservativo durante il periodo di trattamento di OLE e per almeno 28 giorni dopo l'ultima dose di fenebrutinib in aperto, per evitare di esporre l'embrione. Gli uomini devono inoltre astenersi dalla donazione di sperma durante questo stesso periodo.
    E.4Principal exclusion criteria
    • A diagnosis of PPMS or non-active SPMS
    • Disease duration of > 10 years from the onset of symptoms and an EDSS score at screening < 2.0
    • Any known or suspected active infection at screening, including but not limited to a positive screening tests for Hepatitis B and C, an active or latent or inadequately treated infection with tuberculosis (TB), a confirmed or suspected progressive multifocal leukoencephalopathy (PML)
    • History of cancer including hematologic malignancy and solid tumors within 10 years of screening.
    • Known presence of other neurological disorders, clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease
    • Any concomitant disease that may require chronic treatment with systemic corticosteroids, immunosuppressants or specific medication that could impact the primary evaluation of the study.
    • History of alcohol or other drug abuse within 12 months prior to screening
    • Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period
    • Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization
    • Female participants who are pregnant or breastfeeding or intending to become pregnant during the study or 8 weeks (with ATEP) after final dose of study drug
    • Male participants intending to father a child during the study or 8 weeks (with ATEP) after final dose of study drug
    •Diagnosi di SMPP o SMSP non attiva
    •Durata della malattia >10 anni dall'insorgenza dei sintomi e un punteggio EDSS <2,0 allo screening
    •Qualsiasi infezione attiva accertata o sospetta allo screening o al basale compreso Test di screening positivi per epatite B e C attiva, latente o trattata in modo inadeguato, evidenza di infezione da tubercolosi (TB) attiva o latente o trattata in modo inadeguato, anamnesi di leucoencefalopatia multifocale progressiva (LMP) confermata o sospetta
    •Anamnesi di cancro, inclusa neoplasia maligna ematologica e tumori solidi, nei 10 anni precedenti allo screening
    •Presenza nota di altre patologie neurologiche,evidenza di malattia cardiovascolare,psichiatrica,polmonare, renale,epatica metabolica o endocrina
    • Qualsiasi malattia concomitante che potrebbe necessitare di un trattamento cronico con immunosoppressori o corticosteroidi sistemici durante lo studio
    • Pregresso abuso di alcol o altre sostanze stupefacenti nei 12 mesi precedenti allo screening
    •Trattamento precedente con qualsiasi altro farmaco immunomodulatorio o immunosoppressivo, non già elencato, senza un washout adeguato
    •Trattamento con qualsiasi vaccino vivo-attenuato nelle 6 settimane precedenti alla randomizzazione
    •Donne cheintendono iniziare una gravidanza durante lo studio o nelle 8 settimane (con ATEP) successive alla dose finale di farmaco dello studio
    •Uomini che intendono procreare durante lo studio o nelle 8 settimane (con ATEP) successive alla dose finale di farmaco dello studio
    E.5 End points
    E.5.1Primary end point(s)
    1. Time to onset of cCDP12
    2. Annualized relapse rate
    1.Tempo all'insorgenza di progressione della disabilità confermata composita a 12 settimane (cCDP12),
    2.Tasso annualizzato di recidive
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Time from baseline to the first occurrence of a progression event and must be confirmed at a regularly scheduled visit that is at least 12 weeks after the initial disability progression
    2. 96 Weeks
    1.Periodo di tempo trascorso dal basale alla prima comparsa di un evento di progressione secondo almeno uno dei seguenti tre criteri; deve essere confermato a una visita regolarmente programmata che abbia luogo almeno 12 settimane dopo la progressione iniziale della disabilità
    2. 96 settimane
    E.5.2Secondary end point(s)
    1. Time to onset of cCDP24
    2. Time to onset of CDP12
    3. Time to onset of CDP24
    4. Total number of gadolinium-enhancing lesions on T1-weighted MRI lesions as detected by MRI
    5. Total number of new and/or enlarging T2-weighted lesions as detected by MRI
    6. Rate of percent change in total brain volume as assessed by MRI
    7. Rate of change from baseline in patient-reported physical impacts of MS, as measured by the Multiple Sclerosis Impact Scale (29-Item), Version 2 (MSIS-29 v2) physical scale)
    8. Time to onset of 12-week confirmed 4-point worsening in SDMT score
    9. Change from baseline to Week 48 in the concentration of serum neurofilament light chain (NfL)
    10. The nature, frequency, timing, and severity of adverse events; serious adverse events; and adverse events leading to study treatment discontinuation or dose interruptions
    11. Change from baseline in targeted vital signs
    12. Change from baseline in targeted ECG parameters
    13. Change from baseline in clinical laboratory results
    14. Proportion of patients with suicidal ideation or behavior
    15. Plasma concentration of fenebrutinib at specified timepoints; 1.Tempo all'insorgenza di cCDP24
    2.Tempo all'insorgenza di CDP12
    3.Tempo all'insorgenza di CDP24
    4.Numero totale di lesioni evidenziate da gadolinio sulla RM pesata in T1 (T1Gd+), come rilevato dalla RM
    5.Numero totale di lesioni pesate in T2 di nuova insorgenza e/o in allargamento rilevate dalla RM
    6.Tasso di variazione percentuale del volume totale del cervello dalla settimana 24, come valutato dalla RM
    7.Tasso di variazione dal basale degli impatti fisici della SM riferiti dal paziente,come misurato dalla scala per la valutazione dell'impatto della sclerosi multipla (Multiple Sclerosis Impact Scale; 29 item), v.2 (MSIS-29 v2) scala fisica
    8.Tempo di comparsa di un evento di progressione di 4 punti nel punteggio del test di modalità di digitazione di simboli (SDMT)
    9.Variazione dal basale alla settimana 48 nella concentrazione della catena leggera del neurofilamento (NfL) nel siero
    10.Natura, frequenza, tempistiche e gravità degli eventi avversi; eventi avversi seri ed eventi avversi che causano l'interruzione del trattamento dello studio o le sospensioni delle dosi
    11.Variazione dal basale nei segni vitali bersaglio
    12.Variazione dal basale nei parametri dell'ECG bersaglio
    13.Variazione dal basale dei risultati clinici di laboratorio
    14.Percentuale di pazienti con ideazione o comportamento suicidario,
    15.Concentrazione plasmatica di fenebrutinib in momenti temporali specificati
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Time from baseline to first occurrence of a progression event and mustbe confirmed at least 24wks after initial disability progression.
    2.Time from baseline to first occurrence of a progression event and must be confirmed at least 12wks after initial disability progression
    3.Time from baseline to first occurrence of a progression event and mustbe confirmed at least24wks after initial disability progression
    4-5.Timepoints up to primary analysis
    6.From Wk24 to Wk96
    7.Atbaseline, Wk12,24,36,48,60,72,84,96
    8.Time frombaseline to first occurrence of 4-point worsening in SDMT event and must be confirmed at least 12 wks after the initial event
    9.Baseline to Wk 48
    10.Baseline to prim. analysis
    11-14.Baseline to primary analysis
    15.Wk 4,12,24,48,72,96and at treatment discontinuation
    1.T. dal basale alla prima comparsa di un evento di progressione confermato almeno 24 sett.dopo la progressione iniziale della disabilità
    2.T. dal basale alla prima comparsa di un evento di progressione confermato almeno 12 sett.dopo la progressione iniziale della disabilità
    3.T. dal basale alla prima comparsa di un evento di progressione confermato almeno 24 sett.dopo la progressione iniziale della disabilità
    4-5.Timepoints sino all'analisi primaria
    6.Dal sett.24 a 96
    7. Al basale,sett.12,24,36,48,60,72,84,96
    8.T. dal basale alla 1°comparsa di un evento di progressione di 4punti nel punteggio SDMTconfermato almeno 12sett.dopo l'evento iniziale
    9.Dal basale a sett.48
    10.Dal basale all’analisi prim.
    11-14.Dal basale all'analisi prim.
    15.Sett.4,12,24,48,72,96,all'interruzione del trattamento
    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) 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Double-Dummy
    Double-Dummy
    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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA78
    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
    United States
    Finland
    France
    Netherlands
    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 years5
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    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: 734
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 396
    F.4.2.2In the whole clinical trial 734
    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 Decision2021-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-16
    P. End of Trial
    P.End of Trial StatusOngoing
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