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    Summary
    EudraCT Number:2020-003413-35
    Sponsor's Protocol Code Number:WN42349
    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 number2020-003413-35
    A.3Full title of the trial
    A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD)
    STUDIO MULTICENTRICO, A SINGOLO BRACCIO, IN APERTO PER VALUTARE LA SICUREZZA E L’EFFICACIA A LUNGO TERMINE DI SATRALIZUMAB IN PAZIENTI CON DISTURBO DELLO SPETTRO DELLA NEUROMIELITE OTTICA (NMOSD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD)
    STUDIO MULTICENTRICO, A SINGOLO BRACCIO, IN APERTO PER VALUTARE LA SICUREZZA E L’EFFICACIA A LUNGO TERMINE DI SATRALIZUMAB IN PAZIENTI CON DISTURBO DELLO SPETTRO DELLA NEUROMIELITE OTTICA (NMOSD)
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberWN42349
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffman-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 number000000
    B.5.5Fax number000000
    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 Yes
    D.2.1.1.1Trade name Enspryng
    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 nameSatralizumab
    D.3.2Product code [RO5333787]
    D.3.4Pharmaceutical form 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 INNSATRALIZUMAB
    D.3.9.1CAS number 1535963-91-7
    D.3.9.2Current sponsor codeRO5333787
    D.3.9.4EV Substance CodeSUB195082
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 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
    Neuromyelitis Optic Spectrum Disorder
    Disturbo dello spettro della neuromielite ottica
    E.1.1.1Medical condition in easily understood language
    Neuromyelitis Optic Spectrum Disorder
    Disturbo dello spettro della neuromielite ottica
    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 10077875
    E.1.2Term Neuromyelitis optica spectrum disorder
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Safety Objective
    - To evaluate the long-term safety of satralizumab in patients with NMOSD.
    Efficacy Objective
    The efficacy objective for this study is to evaluate long-term efficacy of satralizumab on the basis of the following endpoints:
    - Time to first relapse (TFR) and proportion of patients who are relapsefree
    - Annualized relapse rate (ARR)
    - Change in Expanded Disability Status Scale (EDSS) score
    - Time to EDSS worsening and proportion of patients without EDSS worsening
    -Change in visual acuity
    Obiettivo di sicurezza
    - Valutare la sicurezza a lungo termine di satralizumab in pazienti con NMOSD.
    Obiettivo di efficacia
    L’obiettivo di efficacia di questo studio è valutare l’efficacia a lungo termine di satralizumab sulla base dei seguenti endpoint:
    - Tempo alla prima ricaduta (TFR) e percentuale di pazienti senza ricadute
    - Tasso annualizzato di ricadute (ARR)
    - Modifica del punteggio EDSS (Expanded Disability Status Scale)
    - Tempo al peggioramento dell’EDSS e percentuale di pazienti senza peggioramento dell’EDSS
    - Alterazione dell’acuità visiva
    E.2.2Secondary objectives of the trial
    To further evaluate the risks of serious infections and hepatotoxicity in patients with NMOSD who are treated with satralizumab
    Valutare ulteriormente i rischi di infezioni gravi ed epatotossicità in pazienti con NMOSD trattati con satralizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet the following criteria for study entry:
    - Participated in Study BN40898 or Study BN40900 with satralizumab in NMOSD, are on ongoing satralizumab treatment and were AQP4-IgG seropositive at screening in these studies. Patients with NMOSD who were AQP4-IgG seronegative at screening in Study BN40898 or Study BN40900 can be enrolled if the investigator considers the continued treatment with satralizumab to be beneficial for the patient.
    - Signed Informed Consent Form (ICF).
    - Ability to comply with the study protocol
    - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 3 months after the final dose of satralizumab.
    A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (=12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
    The following are examples of adequate contraceptive methods: bilateral tubal ligation; male sterilization; hormonal contraceptives; hormonereleasing intrauterine devices; copper intrauterine devices; male or female condom with or without spermicide; and cap, diaphragm, or sponge with spermicide.
    The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local ICF.
    I pazienti devono soddisfare i seguenti criteri per l’ammissione allo studio:
    - Partecipazione allo studio BN40898 o allo studio BN40900 con satralizumab sul NMOSD, trattamento in corso con satralizumab e sieropositività ad AQP4-IgG allo screening in questi studi. I pazienti con NMOSD risultati sieronegativi ad AQP4-IgG allo screening nello studio BN40898 o nello studio BN40900 possono essere arruolati qualora lo sperimentatore ritenga la prosecuzione del trattamento con satralizumab di beneficio per il paziente.
    - Modulo di consenso informato (ICF) firmato.
    - Capacità di rispettare il protocollo di studio
    - Per le donne in età fertile: consenso all’astinenza (astenersi da rapporti eterosessuali) o all’utilizzo di misure contraccettive adeguate durante il periodo di trattamento e per 3 mesi dopo la dose finale di satralizumab.
    Una donna si considera in età fertile quando si trova in età postmenarca e prima di raggiungere uno stato postmenopausale (=12 mesi continui di amenorrea senza causa identificata diversa dalla menopausa), a esclusione di una condizione di sterilità permanente a seguito di un intervento chirurgico (ovvero, rimozione di ovaie, tube di Falloppio e/o utero) o in ragione di un’altra causa secondo quanto determinato dallo sperimentatore (per es., agenesia mülleriana). La definizione
    di “in età fertile” può essere adattata in modo da allinearsi con le linee guida o le normative locali.
    Di seguito sono riportati alcuni esempi di metodi contraccettivi adeguati: legatura delle tube bilaterale; sterilizzazione maschile; contraccettivi ormonali; dispositivi intrauterini a rilascio di ormoni; dispositivi intrauterini in rame; profilattico maschile o femminile con o senza spermicida; cappuccio, diaframma o spugna con spermicida. L’affidabilità dell’astinenza sessuale dovrebbe essere valutata in rapporto alla durata della sperimentazione clinica e allo stile di vita preferito e abituale della paziente. Astinenza periodica (per es., metodo Ogino-Knaus, metodo dell’ovulazione Billings, metodo sintotermico o metodo post-ovulatorio) e coito interrotto non sono metodi adeguati di contraccezione. Se richiesto dalle linee guida o dalle normative locali, l’ICF locale includerà una descrizione dei metodi contraccettivi localmente riconosciuti come adeguati e informazioni in merito all’affidabilità dell’astinenza.
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from study entry:
    - Use of prohibited medication
    - Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of study drug. Women of childbearing potential must have a negative urine pregnancy test result on the baseline visit prior to initiation of study drug.
    - Evidence of any serious uncontrolled concomitant diseases that may preclude patient participation, such as: other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency.
    - Known active infection that requires delaying the next satralizumab dose at the time of enrollment a a In case of an active infection, the patient should remain in the parent study, as governed by that protocol, and may enroll in this study once the active infection is controlled.
    - NMOSD relapse at the time of enrollment .In case of a relapse, the patient should remain in the parent study, as governed by that protocol, and may enroll in this study once the patient is stable.
    - Laboratory abnormalities at the last assessment in Study BN40898 or Study BN40900 that preclude re-treatment with satralizumab . If a patient does not meet the criteria to restart treatment with satralizumab based on laboratory assessments, the patient should remain in the parent study and the baseline visit should be delayed. The last assessment before enrollment must meet the re-treatment criteria.
    I pazienti che soddisfano uno qualsiasi dei seguenti criteri verranno esclusi dalla partecipazione allo studio:
    - Uso di farmaci non consentiti
    - Gravidanza o allattamento, o intenzione di rimanere incinta durante lo studio o entro 3 mesi dall’ultima dose del farmaco in studio. Le donne in età fertile devono sottoporsi a un test di gravidanza sulle urine che deve risultare negativo alla visita basale prima dell’inizio del trattamento con il farmaco in studio.
    - Evidenza di qualsiasi malattia concomitante grave non controllata che possa precludere la partecipazione del paziente, come ad esempio: altre malattie del sistema nervoso, malattie cardiovascolari, malattie ematologiche/emopoiesi, malattie respiratorie, malattie muscolari, malattie endocrine, malattie renali/urologiche, malattie del sistema digerente, immunodeficienza grave congenita o acquisita.
    - Infezione attiva nota che richiede la posticipazione della successiva dose di satralizumab al momento dell’arruolamento. In caso di infezione attiva, il paziente deve rimanere nello studio originario, come disciplinato dal relativo protocollo, con la possibilità di arruolarsi in questo studio una volta che l’infezione attiva sarà stata controllata.
    - Ricaduta del NMOSD al momento dell’arruolamento. In caso di ricaduta, il paziente deve rimanere nello studio originario, come disciplinato dal relativo protocollo, con la possibilità di arruolarsi in questo studio una volta che il paziente risulterà stabile.
    - Anomalie di laboratorio all’ultima valutazione nell’ambito dello studio BN40898 o dello studio BN40900 che precludono la ripresa del trattamento con satralizumab . Se un paziente non soddisfa i criteri per la ripresa del trattamento con
    satralizumab sulla base di valutazioni di laboratorio, dovrà rimanere nello studio originario e la visita basale dovrà essere posticipata. L’ultima valutazione prima dell’arruolamento deve soddisfare i criteri di ripresa del trattamento.
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence and severity of adverse events (AE), adverse events of special interest (AESI), serious AEs (SAE), and selected AEs
    - Vital signs (temperature, blood pressure, and pulse rate), clinical laboratory tests (hematology, chemistry, and urinalysis), 12-lead
    electrocardiograms (ECG), and suicidality (Columbia-Suicide Severity Rating Scale [C-SSRS])
    - Incidenza e gravità di eventi avversi (EA), eventi avversi di interesse speciale (AESI), eventi avversi gravi (SAE) ed eventi avversi selezionati
    - Segni vitali (temperatura, pressione sanguigna e frequenza cardiaca), test clinici di laboratorio (ematologia, ematochimica e analisi delle urine), elettrocardiogramma a 12 derivazioni (ECG) e propensione al suicidio (Columbia-Suicide Severity Rating Scale [C-SSRS])
    E.5.1.1Timepoint(s) of evaluation of this end point
    -
    -
    E.5.2Secondary end point(s)
    All efficacy analyses will be based on the ITT population and the ALLSA population. For both populations, data from Study WN42349 will be combined with data from the Studies BN40898 and BN40900. The definitions are in line with Studies BN408989 and BN40900 to investigate long-term efficacy by summarizing the data of the parental studies and this Study WN42349.
    Tutte le analisi di efficacia saranno basate sulla popolazione ITT e sulla popolazione ALLSA. Per entrambe le popolazioni, i dati dello studio WN42349 saranno combinati con i dati degli studi BN40898 e BN40900. Le definizioni sono in linea con gli studi BN408989 e BN40900 al fine di indagare l’efficacia a lungo termine mediante riepilogo dei dati degli studi originali e del presente studio WN42349.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The time to first relapse (TFR) efficacy endpoint is based on several endpoint definitions to accommodate different estimand strategies. The most important intercurrent event is the use of therapy for the treatment of an acute NMOSD relapse (rescue therapy). For the treatment policy strategy, the use of rescue therapy is ignored. Therefore, in the analysis for the treatment policy estimand the TFR is defined as the time from randomization in ITT or first dose of satralizumab in ALLSA to the first protocol-defined relapse as assessed by the investigator (iPDR).
    L’endpoint di efficacia del tempo alla prima ricaduta (TFR) si basa su diverse definizioni dell’endpoint per coerenza con diverse strategie di estimand. Il più importante evento intercorrente è l’uso della terapia per il trattamento di una ricaduta di NMOSD acuta (terapia di salvataggio). Per la strategia basata sulla politica di trattamento, l’uso della terapia di salvataggio viene ignorato. Pertanto, nell’analisi per l’estimand della politica di trattamento e il TFR è definito come il tempo dalla randomizzazione in ITT o dalla prima dose di satralizumab in ALLSA alla prima ricaduta definita dal protocollo secondo quanto valutato dallo sperimentatore (iPDR).
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    in aperto
    open label
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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
    Georgia
    Japan
    Korea, Republic of
    Malaysia
    Taiwan
    Turkey
    Ukraine
    United States
    Bulgaria
    Croatia
    Hungary
    Italy
    Poland
    Romania
    Spain
    United Kingdom
    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 this study is defined as the date when the last patient, last visit (LPLV), occurs. The treatment period ends 3 years after the date
    the first patient enrolls in the study.
    Il termine di questo studio è definito come la data dell’ultima visita dell’ultimo paziente (LPLV). Il periodo di trattamento termina 3 anni dopo la data di arruolamento del primo paziente nello studio.
    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 months3
    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 months3
    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 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 116
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 86
    F.4.2.2In the whole clinical trial 127
    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)
    The Sponsor will offer continued access to Roche IMP satralizumab free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product.
    The Roche Global Policy on Continued Access to Investigational Medicinal Product is available at the following Website:
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    Lo sponsor offrirà un accesso continuato e gratuito al medicinale sperimentale satralizumab di Roche per i pazienti idonei in conformità alla Politica globale di Roche sull’accesso continuato al medicinale sperimentale.
    La Politica globale di Roche sull’accesso continuato al farmaco sperimentale è disponibile sul seguente sito Web:
    http://www.roche.com/policy_continued_access_to_investigational_medicine.pdf
    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 Decision2021-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-10
    P. End of Trial
    P.End of Trial StatusOngoing
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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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