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    Summary
    EudraCT Number:2016-001948-19
    Sponsor's Protocol Code Number:IM101-603
    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:2021-05-25
    Trial results View 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 number2016-001948-19
    A.3Full title of the trial
    A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sj¿grens Syndrome
    Studio di Fase 3 Randomizzato in Doppio-Cieco controllato con Placebo per valutare l¿Efficacia e la Sicurezza di Abatacept sotto cute in pazienti Adulti con Sindrome di Sj¿gren Primaria Attiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sj¿grens Syndrome
    Studio per valutare l¿Efficacia e la Sicurezza di Abatacept in pazienti Adulti con Sindrome di Sj¿gren Primaria Attiva
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberIM101-603
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02915159
    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 pointGCT-SU
    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 number000
    B.5.5Fax number000
    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 Yes
    D.2.1.1.1Trade name Orencia
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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.3.4Pharmaceutical form Solution for 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 INN00305800
    D.3.9.1CAS number 332348-12-6
    D.3.9.2Current sponsor codeBMS-188667
    D.3.9.4EV Substance CodeSUB20635
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeProteina di fusione
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adults with moderately to severely Active Primary Sjogrens Syndrome
    Adulti con Sindrome di Sjogren Attiva da moderata a severa
    E.1.1.1Medical condition in easily understood language
    Sjogrens Syndrome
    Sindrome di Sjogrens
    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 PT
    E.1.2Classification code 10048676
    E.1.2Term Sjogren-Larsson syndrome
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10040766
    E.1.2Term Sjogren's disease
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10040767
    E.1.2Term Sjogren's syndrome
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10042846
    E.1.2Term Syndrome Sjogren's
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10040765
    E.1.2Term Sjogren's
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The Primary Objective of this study is to compare the mean change from
    baseline (Day 1) to Day 169 in ESSDAI of abatacept versus placebo in
    subjects with moderate to severe pSS
    L'obiettivo principale di questo studio è quello di confrontare la variazione media dal basale (giorno 1) al giorno di 169 nell¿ESSDAI di abatacept rispetto al placebo in soggetti con pSS da moderata a grave
    E.2.2Secondary objectives of the trial
    - To compare the mean change from baseline (Day 1) to Day 169 in
    EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) of
    abatacept versus placebo in subjects with moderate to severe pSS.
    - To compare the mean changes from baseline (Day 1) to Day 169 in the
    stimulated whole salivary flow of abatacept versus placebo in subjects
    with residual stimulated whole salivary flow of at least 0.1 mL/min at
    baseline
    - Confrontare la variazione media di abatacept rispetto al placebo dal basale (giorno 1) al giorno 169 nel paziente con sindrome di Sjogren come riportato nell'EULAR (ESSPRI) in soggetti con pSS da moderata a grave.
    - Confrontare i cambiamenti medi di abatacept rispetto al placebo dal basale (giorno 1) al giorno di 169 dell'intero flusso salivare stimolato in soggetti con l'intero flusso salivare stimolato di almeno 0,1 mL / min a al basale
    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: Pharmacokinetic sampling sub-study (N = 40) will be conducted during
    the double-blind treatment period to collect additional PK samples from
    those subjects that sign consent to participate (intitial protocol's version, dated 23Jun2016, see section 5.5): to measure concentrations
    of abatacept in serum.
    Additional Research Collection (intitial protocol's version, dated
    23Jun2016, see section 5.6.8):
    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.
    Labial Salivary Gland or Parotid Gland Biopsy (intitial protocol's version,
    dated 23Jun2016, see section 5.9):
    Biopsy specimen will be read centrally to determine histology and
    examined for RNA expression

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Farmacocinetica
    Durante il periodo di trattamento in doppio cieco sar¿ condotto Sotto-studio di Farmacocinetica di campionamento (N = 40) per raccogliere campioni supplementari PK da quei soggetti che firmano il consenso a partecipare (versione di protocollo iniziale, datata 23giu2016, vedere la sezione 5.5): per misurare le concentrazioni di abatacept nel siero.
    Campionamento per Ricerca Addizionale (versione di protocollo inziale, datata 23giu2016, vedere la sezione 5.6.8):
    per espandere la capacit¿ di traslazione di R&D di Bristol-Myers Squibb, e sosterr¿ gli obiettivi di ricerca ancora non definiti per portare avanti la nostra comprensione della malattia e le opzioni per il trattamento.

    Pu¿ anche essere utilizzato per sostenere le richieste delle autorit¿ sanitarie per l'analisi e l'avanzamento dello sviluppo farmacodiagnostico per migliori farmaci bersaglio per i pazienti adatti. Questo potrebbe includere anche l'esplorazione genetica / genomica volta a esplorare i percorsi di malattia, la progressione e la risposta al trattamento, ecc Biopsia della Ghiandola Salivare Labiale o Ghiandola Parotide (versione di protocollo inziale, datata 23Jun2016, vedi sezione 5.9): il campione bioptico verr¿ letti centralmente per determinare l'istologia ed per l'espressione di RNA esaminato
    E.3Principal inclusion criteria
    - ESSDAI score of at least 5
    - Positive anti-SS-A/Ro antibody at screening
    - Meet the proposed 2015 ACR/EULAR Classification Criteria for
    Sjögren's Syndrome
    • Punteggio ESSDAI di almeno 5
    • Positività allo screening agli anticorpi anti-SS-A/Ro
    • Soddisfare i criteri di classificazione proposti 2015 ACR / EULAR per la sindrome di Sjögren
    E.4Principal exclusion criteria
    - Secondary sjogrens syndrome
    - Active life-threatening or organ-threatening complications of
    Sjögren's-syndrome
    - Other medical condition associated with sicca syndrome
    • Sindrome di Sjogrens Secondaria
    • Complicanze della Sindrome di Sjögren's Attiva con pericolo di vita o complicanze d’organo
    • Altra condizione medica associata con la sindrome da secchezza
    E.5 End points
    E.5.1Primary end point(s)
    The mean change from baseline (Day 1) to Day 169 in ESSDAI
    La variazione media dal basale (giorno 1) al giorno 169 in ESSDAI
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mesi
    E.5.2Secondary end point(s)
    - The change from baseline (Day 1) to Day 169 in ESSPRI
    - The change from baseline (Day 1) in the stimulated whole salivary
    flow to Day 169 among subjects with stimulated whole salivary flow of
    at least 0.1 mL/min
    - Proportion of subjects with a least one positive immunogenicity
    response )
    - Safety (proportion of subjects with adverse events, deaths, SAEs, and
    AEs leading to discontinuation and proportion of laboratory marked
    abnormalities) up to Day 169 and during the cumulative abatacept
    period and follow-up period
    ¿ Il cambiamento dal basale (giorno 1) al giorno 169 in ESSPRI
    ¿ Il cambiamento dal basale (giorno 1) nell¿intero flusso salivare stimolato a giorno 169 tra i soggetti con intero flusso salivare stimolato di almeno 0,1 ml/min
    ¿ Percentuale di soggetti con almeno una risposta positiva di immunogenicit¿
    ¿ Sicurezza (quota di soggetti con eventi avversi, decessi, eventi avversi gravi, e AEa che hanno portato alla discontinuazione e la percentuale di marcate anomalie di laboratorio) fino al giorno 169 e durante il periodo di abatacept cumulativa e il periodo di follow-up
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Day 1 to Day 169
    - Day 1 to Day 169
    - Day 1 to 84 days after the last dose of study drug
    - Day 1 to 56 days after the last dose of study drug
    ¿ Dal Giorno 1 al Giorno 169
    ¿ Dal Giorno 1 al Giorno 169
    ¿ Dal Giorno 1 a 84 giorni dopo l'ultima dose del farmaco in studio
    ¿ Dal Giorno 1 a 56 giorni dopo l'ultima dose del farmaco in 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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity Assessments
    Immunogenicity Assessments
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Japan
    Korea, Republic of
    Mexico
    Denmark
    France
    Germany
    Italy
    Norway
    Sweden
    Czechia
    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
    LVLS
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    E.8.9.2In all countries concerned by the trial months11
    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: 287
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 41
    F.4.2.2In the whole clinical trial 288
    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 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 responsible health
    authority and ethics committee or through another mechanism at the
    discretion of BMS
    ooo
    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 Decision2017-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-12-03
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