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    Summary
    EudraCT Number:2020-004461-40
    Sponsor's Protocol Code Number:IM011-077
    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:2021-10-18
    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 number2020-004461-40
    A.3Full title of the trial
    An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis
    Studio di estensione multicentrico in aperto per valutare la sicurezza e l'efficacia a lungo termine di BMS-986165 in partecipanti con morbo di Crohn da moderato a grave o con colite ulcerosa da moderata a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term Safety and Efficacy of BMS-986165 in Participants with Crohn's Disease or Ulcerative Colitis
    Sicurezza ed efficacia a lungo termine del BMS-986165 nei partecipanti con morbo di Crohn o colite ulcerosa
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberIM011-077
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04877990
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1258-3838
    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 pointGSM-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 namedeucravacitinib
    D.3.2Product code [BMS-986165]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdeucravacitinib
    D.3.9.1CAS number 1609392-27-9
    D.3.9.2Current sponsor codeBMS-986165
    D.3.9.4EV Substance CodeSUB180283
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    moderate to severe Crohn's Disease (CD), moderate to severe Ulcerative Colitis (UC)
    Malattia di Crohn (MC) da moderata a grave, Colite ulcerosa (CU) da moderata a grave
    E.1.1.1Medical condition in easily understood language
    Crohn's Disease, Ulcerative Colitis
    Malattia di Crohn, Colite ulcerosa
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal 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 assess the safety and tolerability of long-term use of BMS-986165 in participants with moderate to severe Crohn's Disease or with moderate to severe Ulcerative Colitis.
    Valutare la sicurezza e la tollerabilità dell'uso a lungo termine di BMS-986165 in partecipanti con malattia di Crohn da moderata a grave o colite ulcerosa con moderata a grave.
    E.2.2Secondary objectives of the trial
    NA
    NA
    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: Initial
    Date: 25/11/2020
    Title: An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn’s Disease or Moderate to Severe Ulcerative Colitis
    Objectives: Additional research is optional for all study participants, except where retention and/or collection is prohibited by local laws or regulations, IECs, or institutional requirements. This collection for additional research is intended to expand the translational research and development capability at BMS 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.

    Pharmacogenomics
    Version: Initial
    Date: 25/11/2020
    Title: An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn’s Disease or Moderate to Severe Ulcerative Colitis
    Objectives: Additional research is optional for all study participants, except where retention and/or collection is prohibited by local laws or regulations, IECs, or institutional requirements. This collection for additional research is intended to expand the translational research and development capability at BMS 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.

    Farmacogenetica
    Versione: Initial
    Data: 25/11/2020
    Titolo: Studio di estensione multicentrico in aperto per valutare la sicurezza e l'efficacia a lungo termine di BMS-986165 in partecipanti con morbo di Crohn da moderato a grave o con colite ulcerosa da moderata a grave
    Obiettivi: L’Additional research è opzionale per tutti i partecipanti allo studio, tranne nel caso in cui la conservazione e / o la raccolta è vietata dalle leggi o dai regolamenti locali,comitati etici o da requisiti istituzionali. Questa raccolta per ulteriori ricerche ha lo scopo di espandere la capacità di ricerca e l’ R&D traslazionale presso Bristol-Myers Squibb e sarà di supporto per scopi di ricerca ancora indefiniti che faranno avanzare la nostra comprensione della malattia e le eventuali opzioni per il trattamento. Può anche essere usato a supporto delle richieste dell'Autorità Competente per l'analisi e lo sviluppo della farmacodiagnostica allo scopo di indirizzare i farmaci target ai pazienti giusti. Questo può includere anche l'esplorazione genetica / genomica volta a esplorare la pathway della malattia, la progressione e la risposta al trattamento.

    Farmacogenomica
    Versione: Initial
    Data: 25/11/2020
    Titolo: Studio di estensione multicentrico in aperto per valutare la sicurezza e l'efficacia a lungo termine di BMS-986165 in partecipanti con morbo di Crohn da moderato a grave o con colite ulcerosa da moderata a grave
    Obiettivi: L’Additional research è opzionale per tutti i partecipanti allo studio, tranne nel caso in cui la conservazione e / o la raccolta è vietata dalle leggi o dai regolamenti locali,comitati etici o da requisiti istituzionali. Questa raccolta per ulteriori ricerche ha lo scopo di espandere la capacità di ricerca e l’ R&D traslazionale presso Bristol-Myers Squibb e sarà di supporto per scopi di ricerca ancora indefiniti che faranno avanzare la nostra comprensione della malattia e le eventuali opzioni per il trattamento. Può anche essere usato a supporto delle richieste dell'Autorità Competente per l'analisi e lo sviluppo della farmacodiagnostica allo scopo di indirizzare i farmaci target ai pazienti giusti. Questo può includere anche l'esplorazione genetica / genomica volta a esplorare la pathway della malattia, la progressione e la risposta al trattamento
    E.3Principal inclusion criteria
    Adults having previously completed Open-label extension treatment in 1 of the parent BMS-986165 CD or UC studies
    Adulti che hanno precedentemente completato il trattamento di estensione in aperto in uno degli studi parentali BMS-986165 CD o UC
    E.4Principal exclusion criteria
    Any disease or medical condition that, in the opinion of the investigator, would make the participant unsuitable for this study, would interfere with the interpretation of participant safety or study results, or is considered unsuitable by the investigator for any other reason
    Qualsiasi malattia o condizione medica che, a giudizio dello sperimentatore, renderebbe il partecipante inadatto a questo studio, interferirebbe con l'interpretazione della sicurezza dei partecipanti o dei risultati dello studio, o è ritenuto inadatto dallo Sperimentatore per qualsiasi altro motivo.
    E.5 End points
    E.5.1Primary end point(s)
    - Number and proportion of participants experiencing AEs, SAEs, AEs leading to study discontinuation, and AEIs.
    - Number and proportion of participants experiencing abnormalities in laboratory testing, ECG, and vital sign parameters over time.
    - Changes from Day 1 for laboratory testing, ECG, and vital signs.
    - Numero e percentuale di partecipanti che hanno manifestato AE, SAE, AE che porta all'interruzione dello studio e agli AEI.
    - Numero e percentuale di partecipanti che hanno riscontrato anomalie in test di laboratorio, ECG e parametri dei segni vitali nel tempo.
    - Modifiche dal giorno 1 per i test di laboratorio, ECG e segni vitali.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately every 2 years
    Approssimativamente ogni 2 anni
    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 Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    Brazil
    Canada
    China
    Israel
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    Taiwan
    United States
    Belgium
    Denmark
    France
    Germany
    Hungary
    Ireland
    Italy
    Netherlands
    Poland
    Portugal
    Romania
    Spain
    Switzerland
    United Kingdom
    Czechia
    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 months7
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days18
    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: 279
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 300
    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)
    Fare riferimento alla sezione 7.8 del protocollo. A conclusione dello studio, i partecipanti che continuano a dimostrare benefici clinici saranno idonei a ricevere il trattamento in studio fornito da BMS. Il trattamento in studio sarà fornito tramite un'estensione dello studio, uno studio di rollover che richiede approvazione da parte dell'Autorità competente e del CE.
    Please refer to section 7.8 of the protocol. At the conclusion of the study, participants who continue to demonstrate clinical benefit will be eligible to receive BMS-supplied study treatment. Study treatment will be provided via an extension of the study, a rollover study requiring approval by the responsible Health Authority and IEC, or through another mechanism at the discretion of BMS
    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 Decision2021-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-08-29
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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
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