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    Summary
    EudraCT Number:2019-003932-22
    Sponsor's Protocol Code Number:IM025-017
    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:2021-06-04
    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 number2019-003932-22
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults with Compensated Cirrhosis from Nonalcoholic Steatohepatitis (NASH)
    Studio di Fase 2, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, a dosi multiple per valutare l’efficacia e la sicurezza di BMS-986263 in soggetti adulti con cirrosi compensata dovuta a steatoepatite non alcolica (NASH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (liver disease) from nonalcoholic steatohepatitis (NASH).
    Sicurezza ed efficacia di BMS-986263 in soggetti adulti con cirrosi compensata (malattia epatica) dovuta a steatoepatite non alcolica (NASH).
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberIM025-017
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1241-4762
    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 SponsorBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointHead of the GSM-CT
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance, Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.4Telephone number000000
    B.5.5Fax number000000
    B.5.6E-mailclinical.trials@bms.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 namevND-L02-s0201
    D.3.2Product code [BMS-986263 for injection]
    D.3.4Pharmaceutical form Powder for 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 INNNDT-05-0038
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameNDT-05-0038
    D.3.9.4EV Substance CodeSUB178466
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEmulsion 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
    Compensated Cirrhosis from Nonalcoholic Steatohepatitis (NASH)
    Cirrosi compensata dovuta a steatoepatite non alcolica (NASH)
    E.1.1.1Medical condition in easily understood language
    Compensated Cirrhosis from Nonalcoholic Steatohepatitis (NASH)
    Cirrosi compensata dovuta a steatoepatite non alcolica (NASH)
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10064844
    E.1.2Term Compensated cirrhosis
    E.1.2System Organ Class 100000004871
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10019669
    E.1.2Term Hepatic fibrosis and cirrhosis
    E.1.2System Organ Class 100000004871
    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 BMS-986263 compared with placebo to improve liver fibrosis in participants with compensated cirrhosis due to NASH
    Valutare l’efficacia di BMS-986263 rispetto al placebo per migliorare la fibrosi epatica nei partecipanti con cirrosi compensata dovuta a NASH
    E.2.2Secondary objectives of the trial
    _To further assess the efficacy of BMS-986263 compared with placebo to improve liver fibrosis, as determined by liver biopsy, in participants with compensated cirrhosis due to NASH;
    _To assess the safety and tolerability of BMS-986263 in participants with compensated cirrhosis due to NASH;
    _To assess the PK of BMS-986263 in participants with compensated cirrhosis due to NASH
    - Valutare ulteriormente l’efficacia di BMS-986263 rispetto al placebo nel miglioramento della fibrosi epatica, come determinato dalla biopsia epatica, nei partecipanti con cirrosi compensata dovuta a NASH
    - Valutare la sicurezza e la tollerabilità di BMS 986263 nei partecipanti con cirrosi compensata dovuta a NASH
    - Valutare la PK di BMS-986263 nei partecipanti con cirrosi compensata dovuta a NASH
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Pharmacogenetics
    Version: Revised Protocol 02
    Date: 25/11/2020
    Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple-dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults with Compensated Cirrhosis from Nonalcoholic Steatohepatitis (NASH)
    Objectives: Additional Research is optional for all study participants, except where retention and/or collection is prohibited by local laws or regulations, ethics committees, or institutional requirements. This collection for additional research is intended to expand the translational R&D capability at Bristol-Myers Squibb, and will support as yet undefined research aims that will advance our understanding of disease and options for treatment. It may also be used to support health authority requests for analysis, and advancement of pharmacodiagnostic development to better target drugs to the right patients. This may also include genetic/genomic exploration aimed at exploring disease pathways, progression and response to treatment etc.

    Pharmacogenomics
    Version: Revised Protocol 02
    Date: 25/11/2020
    Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple-dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults with Compensated Cirrhosis from Nonalcoholic Steatohepatitis (NASH)
    Objectives: Additional Research is optional for all study participants, except where retention and/or collection is prohibited by local laws or regulations, ethics committees, or institutional requirements. This collection for additional research is intended to expand the translational R&D capability at Bristol-Myers Squibb, and will support as yet undefined research aims that will advance our understanding of disease and options for treatment. It may also be used to support health authority requests for analysis, and advancement of pharmacodiagnostic development to better target drugs to the right patients. This may also include genetic/genomic exploration aimed at exploring disease pathways, progression and response to treatment etc.

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: _HepQuant- SHUNT Test Substudy (only US sites are participating to this substudy, no further details will be mentioned in this form and no supporting documentation will be provided)
    OBJECTIVES: To assess the effect of treatment with BMS-986263 on liver function

    _MRE Substudy (at Sites Where Available)
    OBJECTIVES: To evaluate the efficacy of BMS-986263 compared with placebo in regards to liver stiffness.

    Farmacogenetica
    Versione: Revised Protocol 02
    Data: 25/11/2020
    Titolo: Studio di Fase 2, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, a dosi multiple per valutare l’efficacia e la sicurezza di BMS-986263 in soggetti adulti con cirrosi compensata dovuta a steatoepatite non alcolica (NASH)
    Obiettivi: La ricerca addizionale è facoltativa per tutti i partecipanti allo studio, tranne nei casi in cui la conservazione e/o la raccolta è vietata dalle leggi e dai regolamenti locali, dai comitati etici, o requisiti istituzionali. Questa raccolta per ulteriori ricerche ha lo scopo di espandere la capacità di ricerca e sviluppo traslazionale presso Bristol-Myers Squibb e sosterrà obiettivi di ricerca ancora non definiti che miglioreranno la nostra comprensione della malattia e opzioni diverse per il trattamento. Può anche essere usato per sostenere richieste di autorità per analisi e avanzamento dello sviluppo della farmacodiagnostica per meglio indirizzare i farmaci ai pazienti più indicati. Questo potrebbe anche includere l'esplorazione genetica / genomica volta ad esplorare i percorsi della malattia, la sua progressione, la risposta al trattamento ecc.

    Farmacogenomica
    Versione: Revised Protocol 02
    Data: 25/11/2020
    Titolo: Studio di Fase 2, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, a dosi multiple per valutare l’efficacia e la sicurezza di BMS-986263 in soggetti adulti con cirrosi compensata dovuta a steatoepatite non alcolica (NASH)
    Obiettivi: La ricerca addizionale è facoltativa per tutti i partecipanti allo studio, tranne nei casi in cui la conservazione e/o la raccolta è vietata dalle leggi e dai regolamenti locali, dai comitati etici, o requisiti istituzionali. Questa raccolta per ulteriori ricerche ha lo scopo di espandere la capacità di ricerca e sviluppo traslazionale presso Bristol-Myers Squibb e sosterrà obiettivi di ricerca ancora non definiti che miglioreranno la nostra comprensione della malattia e opzioni diverse per il trattamento. Può anche essere usato per sostenere richieste di autorità per analisi e avanzamento dello sviluppo della farmacodiagnostica per meglio indirizzare i farmaci ai pazienti più indicati. Questo potrebbe anche includere l'esplorazione genetica / genomica volta ad esplorare i percorsi della malattia, la sua progressione, la risposta al trattamento ecc.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: - HepQuant- SHUNT Test Substudy (solo negli Sati Uniti parteciperanno a questo sottostudio, non verranno menzionati ulteriori dettagli in questo form e non sarà fornita documentazione a supporto)
    OBIETTIVI: Valutare l'effetto del trattamento con BMS-986263 sulla funzionalità epatica

    - MRE Sottostudio (nei centri dove disponibile)
    OBIETTIVI: Valutare l'efficacia di BMS-986263 rispetto al placebo in relazione alla rigidità del fegato.
    E.3Principal inclusion criteria
    - Participants with liver biopsy fibrosis score stage 4 performed within 6 months
    - Men and women must agree to follow methods of contraception
    - Soggetti con biopsia epatica di stadio di fibrosi di 4 eseguita entro 6 mesi
    - Soggetti di sesso maschile e femminile devono acconsentire ad utilizzare metodi di contraccezione
    E.4Principal exclusion criteria
    - Worsening liver disease or any disease might compromise participant safety in the opinion of the investigator;
    - Known immunocompromised status or any disease or condition which might compromise participant safety;
    - Prior exposure to BMS-986263
    - Clinically relevant abnormal physical examination, vital signs, ECG, or clinical laboratory tests;
    - Hepatic decompensation.
    - Peggioramento della malattia epatica o qualsiasi altra malattia che potrebbe compromettere la sicurezza del soggetto partecipante secondo il parere dello sperimentatore;
    - Stato immunocompromesso noto o qualsiasi malattia o condizione che potrebbe compromettere la sicurezza dei soggetti partecipanti;
    - Precedente esposizione a BMS-986263;
    - Esame obiettivo, segni vitali, ECG o test clinici di laboratorio anormali clinicamente rilevanti;
    - Scompenso epatico.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants who achieve = 1 stage improvement in liver fibrosis (NASH CRN Fibrosis Score), as determined by liver biopsy after 12 weeks of treatment;
    Percentuale di partecipanti che raggiungono un miglioramento di stadio = 1 della fibrosi epatica (punteggio della fibrosi CRN NASH), sulla base della valutazione della biopsia epatica dopo 12 settimane di trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 12 weeks of treatment
    dopo 12 settimane di trattamento
    E.5.2Secondary end point(s)
    _Proportion of participants with =1 stage improvement in liver fibrosis with no increase of the NAS [NAFLD (Nonalcoholic fatty liver disease) Activity Score] by = 1 point after 12 weeks of treatment;
    _Proportion of participants with =2 stage improvement in liver fibrosis score (NASH CRN Fibrosis Score) after 12 weeks of treatment;
    _Proportion of participants with = 1 stage improvement in modified Ishak liver fibrosis score after 12 weeks of treatment;
    _Proportion of participants with = 2 stage improvement in modified Ishak liver fibrosis score after 12 weeks of treatment;
    _Change from baseline in collagen proportionate area (CPA) after 12 weeks of treatment;
    _Incidences of SAEs, AEs, clinical laboratory values, vital signs, physical examination findings, and ECGs up to week 36
    _Change from baseline in bone mineral density (BMD), as measured by dual-energy x-ray absorptiometry (DXA), at week 36
    _Plasma concentrations of BMS-986263 day 1 to week 12;
    _Plasma concentrations of DPD (di-retinamide-PEG-diretinamide), day 1 to week 12;
    _Plasma concentrations of S104 (lipid component), day 1 to week 12.
    - Percentuale di partecipanti con miglioramento di stadio =1 della fibrosi epatica senza peggioramento del NAS [NAFLD (steatosi epatica non alcolica) con punteggio di attività =1 punto dopo 12 settimane di trattamento
    - Percentuale di partecipanti con miglioramento di stadio =2 della fibrosi epatica (punteggio della fibrosi CRN NASH) dopo 12 settimane di trattamento
    - Percentuale di partecipanti con miglioramento di stadio =1 della fibrosi epatica nel punteggio di Ishak modificato dopo 12 settimane di trattamento
    - Percentuale di partecipanti con miglioramento di stadio = 2 della fibrosi epatica nel punteggio di Ishak modificato dopo 12 settimane di trattamento
    - Variazione rispetto al basale nell’area proporzioanle di collagene (CPA) dopo 12 settimane di trattamento
    - Frequenza di SAEs, AEs, valori clinici di laboratorio, segni vitali, risultati dell’esame obiettivo ed ECGs fino a 36 settimane di trattamento
    - Variazione rispetto al basale nella densità minerale ossea (BMD), misurata tramite l’assorbimetria a raggi X a doppia energia (DXA), alla settimana 36
    - Concentrazioni plasmatiche di BMS-986263 dal giorno 1 alla settimana 12
    - Concentrazioni plasmatiche di DPD (di-retinamide-PEG-diretinamide) dal giorno 1 alla settimana 12
    - Concentrazioni plasmatiche di S104 (componente lipidica) dal giorno 1 alla settimana 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 1, after 12 weeks of treatment, at Follow-up Week 24 or throughout the study.
    giorno 1, dopo 12 settimane di trattamento, alla settimana 24 di follow-up o per tutta la durata lo studio.
    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 Yes
    E.6.13.1Other scope of the trial description
    Biomarkers
    Biomarkers
    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 trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Brazil
    Canada
    Israel
    Japan
    Korea, Republic of
    Puerto Rico
    Taiwan
    United States
    Belgium
    France
    Germany
    Italy
    Spain
    Switzerland
    United Kingdom
    Argentina
    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
    End of study (EOS) is defined as the last visit or scheduled procedure shown in the Schedule of Activities (Section 1.3 from the protocol) for the last participant. Study completion is defined as the final date on which data for the primary endpoint was or is expected to be collected, if this is not the same. The end of the study for analysis of biomarker samples is included in Section 8.6. of the protocol.
    La fine dello studio (EOS: end of study) è definita come l'ultima visita o procedura programmata descritta nel “Schedule of Activities” (sezione 1.3 del protocollo) per l'ultimo soggetto partecipante. Il completamento dello studio è definito come la data finale sulla quale i dati per l'endpoint primario erano o è previsto che siano raccolti, se queste non coincidono. La fine dello studio per l'analisi dei campioni dei biomarcatori è incluso nella Sezione 8.6. del protocollo.
    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 months9
    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: 189
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 81
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 270
    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)
    At the end of the study, BMS will not continue to provide BMS-supplied study treatment to participants unless BMS chooses to extend the study. The investigator should ensure that participants receive appropriate standard of care to treat the condition under study.
    Alla fine dello studio, BMS non continuerà a fornire il trattamento in studio fornito da BMS ai soggetti partecipanti a meno che BMS non scelga di estendere lo studio. Lo Seprimentatore dovrebbe assicurarsi che i partecipanti ricevano standard di cura appropriato per trattare la condizione in studio.
    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 Decision2021-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-25
    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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