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    Summary
    EudraCT Number:2022-003916-10
    Sponsor's Protocol Code Number:GR-2021-12372898
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-02-08
    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 number2022-003916-10
    A.3Full title of the trial
    Deciphering B and T cell Co-stimulation for the Targeted Treatment of IgG4-Related Disease
    Analisi della co-stimolazione B-T cellulare per la terapia personalizzata della Malattia IgG4-correlata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Abatacept for therapy of IgG4-related disease
    Abatacept per la terapia della malattia IgG4-correlata
    A.3.2Name or abbreviated title of the trial where available
    GR-2021-12372898
    GR-2021-12372898
    A.4.1Sponsor's protocol code numberGR-2021-12372898
    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 SponsorOSPEDALE SAN RAFFAELE
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBando per ricerca finalizzata Giovani Ricercatori 2021 - Ministero della Salute
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCSS Ospedale San Raffaele
    B.5.2Functional name of contact pointClinical Trial Center
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina 58
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number0226436102
    B.5.5Fax number0226432165
    B.5.6E-mailctc.trialstartup@hsr.it
    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 AuthorisationItaly
    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 nameAbatacept
    D.3.2Product code [Abatacept]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNABATACEPT
    D.3.9.1CAS number 332348-12-6
    D.3.9.2Current sponsor codeABATACEPT
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 Yes
    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 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 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
    IgG4-related disease
    Malattia IgG4 correlata
    E.1.1.1Medical condition in easily understood language
    Immune-mediated diseases
    Malattie immuno-mediate
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10071569
    E.1.2Term Immunoglobulin G4 related sclerosing disease
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10071569
    E.1.2Term Immunoglobulin G4 related sclerosing disease
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of abatacept in reducing the risk of disease recurrence at 48 weeks
    Dimostrare l’efficacia di abatacept nel ridurre il rischio di recidiva di malattia a 48 settimane
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of abatacept in patients with IgG4-related disease
    - To study the effects of abatacept on the following measures of disease activity: time to relapse, complete remission, clinical response, IgG4-related disease responder index (IgG4RD-RI), Physician Global Assessment, cumulative steroid dose, soluble biomarkers of B- and T cell activation, transcriptome, selective efficacy in one of the 4 disease phenotypes.
    - Valutare la sicurezza e la tollerabilità di abatacept nei pazienti con malattia IgG4 correlata
    - Studiare gli effetti di abatacept sulle seguenti misure di attività di malattia: tempo alla recidiva, remissione completa, risposta clinica, IgG4-related disease responder index (IgG4RD-RI), Physician Global Assessment, dose cumulativa di steroide, biomarcatori solubili di attivazione B e T cellulare, trascrittoma, efficacia selettiva in uno dei 4 fenotipi di malattia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects of legal age and able to provide informed consent
    2. Patients with active IgG4-related disease naive to therapy or relapsing with an IgG4-RD RI > 2
    3. Achievement of the 2019 ACR/EULAR Classification Criteria of IgG4-related disease.
    1. Soggetti di sesso maschile o femminile maggiorenni e in grado di fornire consenso informato
    2. Pazienti con malattia IgG4 correlata attiva e naive alla terapia o recidivante con un IgG4-RD RI > 2
    3. Raggiungimento dei Criteri Classificativi ACR/EULAR di malattia IgG4 correlata del 2019.
    E.4Principal exclusion criteria
    - Malignancy within 5 years
    - Chronic or history of recurrent infections over 6 months prior to screening
    - Evidence of severe active liver disease unrelated to IgG4RD
    - Concomitant uncontrolled disease that would interfere with the study procedures
    - Positive HIV, HBV, HCV serology
    - Positive quantiferon test
    - Inability to be tapered of glucocorticoid therapy by 8 weeks post randomisation
    - Prior use of B cell depleting agents within 6 months of enrolment
    - Leukopenia, neutropenia, thrombocytopenia, or anemia
    - Serum creatinine > 2.0 mg/dL at the time of randomisation.
    - Positive pregnancy test at screening or during the study, or breast feeding
    - Subjects who do not agree to use methods of contraception.
    - Malignità entro 5 anni
    - Infezioni croniche o anamnestiche ricorrenti nei 6 mesi precedenti lo screening
    - Evidenza di grave malattia epatica attiva non correlata a IgG4RD
    - Malattia concomitante non controllata che potrebbe interferire con le procedure dello studio
    - Sierologia positiva per HIV, HBV e HCV
    - Test quantiferon positivo
    - Impossibilità di ridurre la terapia con glucocorticoidi entro 8 settimane dalla randomizzazione
    - Uso precedente di agenti depletori delle cellule B entro 6 mesi dall'arruolamento
    - Leucopenia, neutropenia, trombocitopenia o anemia
    - Creatinina sierica > 2,0 mg/dL al momento della randomizzazione.
    - Test di gravidanza positivo allo screening o durante lo studio, o allattamento al seno.
    - Soggetti che non accettano di utilizzare metodi contraccettivi.
    E.5 End points
    E.5.1Primary end point(s)
    Reduction of disease recurrence in patients with IgG4-related disease treated with abatacept compared with placebo-treated pazineti
    Riduzione delle recidive di malattia in pazienti con malattia IgG4 correlata trattati con abatacept rispetto a pazineti trattati con placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monthly, up to 12 months
    Cadenza mensile, fino a 12 mesi
    E.5.2Secondary end point(s)
    - time to recurrence
    - complete remission rate
    - clinical response rate
    - impact on IgG4-related disease responder index (IgG4RD-RI)
    - Physician Global Assessment
    - cumulative steroid dose,
    - soluble biomarkers of B and T cell activation, transcriptome
    - selective efficacy in one of the 4 disease phenotypes.
    - tempo alla recidiva
    - tasso di remissione completa
    - tasso di risposta clinica
    - impatto su IgG4-related disease responder index (IgG4RD-RI)
    - Physician Global Assessment
    - dose cumulativa di steroide,
    - biomarcatori solubili di attivazione B e T cellulare, trascrittoma
    - efficacia selettiva in uno dei 4 fenotipi di malattia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monthly, up to 12 months
    Cadenza mensile, fino a 12 mesi
    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 No
    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) 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 trial2
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    LVLS
    LVLS
    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 months0
    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 months0
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 32
    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, we will continue to follow the patients enrolled in the outpatient clinics dedicated to IgG4-related disease at San Raffaele Hospital in Milan and to treat patients with steroid therapy as per clinical practice
    Al termine dello studio si proseguirà a seguire i pazienti arruolati negli ambulatori dedicati alla malattia IgG4 correlata presso Ospedale San Raffaele di Milano e a trattare i pazienti con terapia steroidea come da pratica clinica
    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 Decision2023-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-15
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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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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