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    Summary
    EudraCT Number:2020-000417-33
    Sponsor's Protocol Code Number:VIB0551.P3.S2
    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:2020-10-21
    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 number2020-000417-33
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4 Related Disease
    (short title: MITIGATE – InebilizuMab effIcacy and safeTy in IGg4 relATed disEase)
    Studio di fase 3, randomizzato, in doppio cieco, multicentrico, controllato con placebo, volto a valutare l’efficacia e la sicurezza di Inebilizumab nella malattia IgG4-correlata
    (Titolo breve: MITIGATE – Efficacia e sicurezza di inebilizumab nella malattia IgG4-correlata)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Inebilizumab efficacy and safety in IgG4 related disease
    Efficacia e la sicurezza di Inebilizumab nella malattia IgG4-correlata
    A.3.2Name or abbreviated title of the trial where available
    MITIGATE
    MITIGATE
    A.4.1Sponsor's protocol code numberVIB0551.P3.S2
    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 SponsorVIELABIO Inc.
    B.1.3.4CountryUnited States
    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 supportViela Bio, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationViela Bio, Inc
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressOne Medimmune Way
    B.5.3.2Town/ cityGaithersburg, Maryland
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number0012405580038
    B.5.5Fax number0012407729578
    B.5.6E-mailclinicaltrials@vielabio.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 nameInebilizumab
    D.3.2Product code [Inebilizumab]
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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 INNInebilizumab
    D.3.9.2Current sponsor codeMEDI-551
    D.3.9.3Other descriptive nameafucosylated IgG1 kappa monoclonal antibody
    D.3.9.4EV Substance CodeSUB189141
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 typeInebilizumab is a humanized, affinity-optimized, afucosylated immunoglobulin G1 kappa (IgG1k) monoclonal antibody
    D.IMP: 2
    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 PREDNISONE DOC GENERICI - "5 MG COMPRESSE" 30 COMPRESSE IN BLISTER PVC-PVDC/ALU
    D.2.1.1.2Name of the Marketing Authorisation holderDOC GENERICI SRL
    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 namePrednisone
    D.3.2Product code [Prednisone]
    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 INNPREDNISONE
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 3
    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 CETIRIZINA SANDOZ - 10 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE IN BLISTER PVC/ALU
    D.2.1.1.2Name of the Marketing Authorisation holderSANDOZ S.P.A.
    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 nameCetirizina
    D.3.2Product code [Cetirizina]
    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 INNCETIRIZINA
    D.3.9.2Current sponsor code-
    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.IMP: 4
    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 PARACETAMOLO NOVA ARGENTIA - 500 MG COMPRESSE 20 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderINDUSTRIA FARMACEUTICA NOVA ARGENTIA S.P.A.
    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 nameParacetamolo
    D.3.2Product code [Paracetamolo]
    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 INNPARACETAMOLO
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.IMP: 5
    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 METILPREDNISOLONE HIKMA - 1000 MG POLVERE PER SOLUZIONE INIETTABILE 10 FLACONCINI IN VETRO
    D.2.1.1.2Name of the Marketing Authorisation holderHIKMA FARMACEUTICA (PORTUGAL) S.A.
    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 nameMetilprednisolone
    D.3.2Product code [Metilprednisolone]
    D.3.4Pharmaceutical form Powder and solvent for concentrate 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 INNMETILPREDNISOLONE
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 placeboConcentrate for solution for injection
    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
    Immunoglobulin G4-related disease (IgG4-RD)
    Mallattia immunoglobulina G4-correlata (IgG4-RD)
    E.1.1.1Medical condition in easily understood language
    IgG4-RD is a chronic, relapsing-remitting, immune-mediated fibroinflammatory disorder
    La mallattia immunoglobulina G4-correlata (IgG4-RD) è un disturbo fibroinfiammatorio recidivante-remittente immuno-mediato
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10077271
    E.1.2Term Immunoglobulin G4 related disease
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of inebilizumab in reducing the risk of a disease flare in patients with IgG4-RD
    Valutare l’efficacia di inebilizumab nella riduzione del rischio di riacutizzazione della malattia in pazienti con IgG4-RD.
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of inebilizumab in patients with IgG4-RD.
    .• To evaluate the effect of inebilizumab on other measures of disease activity
    • Valutare la sicurezza e la tollerabilità di inebilizumab in pazienti con IgG4-RD.
    • Valutare l’effetto di inebilizumab su altre misure dell’attività della malattia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female adults, = 18 years of age at time of informed consent.
    2. Written informed consent and any locally required authorization
    3. Clinical diagnosis of IgG4-RD.
    4. Fulfillment of the 2019 ACR/EULAR classification criteria as determined by the Eligibility Committee.
    5. Experiencing (or recently experienced) an IgG4-RD flare that requires initiation or continuation of GC treatment at the time of informed consent
    6. IgG4-RD affecting at least 2 organs/sites at any time in the course of IgG4-RD with documentation to confirm.
    7. Willing and able to comply with the protocol, complete study assessments, and complete the study period.
    8. Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide from Day 1 through to the end of the study and must agree to continue using such precautions for at least 6 months after the final dose of IP.
    Females of childbearing potential must have a negative serum pregnancy test at screening. Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highly effective method of contraception from signing informed consent and must agree to continue using such precautions through the end of the follow-up of the study and at least 180 days after the last dose of IP; cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. A recommendation will be made that the female partners (of childbearing potential) of male study participants should use a highly effective method of contraception other than a barrier method.
    Females of childbearing potential are defined as those who are not surgically sterile (ie, surgical sterilization includes bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or those who are not postmenopausal (defined as 12 months with no menses without an alternative medical cause and a follicle-stimulating hormone within the postmenopausal range as established by the clinical laboratory).
    1. Adulti di sesso maschile o femminile, di età =18 anni al momento del consenso informato.
    2. Consenso informato per iscritto e qualsiasi autorizzazione necessaria a livello locale
    3. Diagnosi clinica di malattia IgG4-correlata.
    4. Adempimento dei criteri di classificazione emessi dall’Organizzazione dei reumatologi americani/Lega europea contro il reumatismo (ACR/EULAR) nel 2019 secondo quanto stabilito dal Comitato di idoneità.
    5. Presenza (o recente presenza) di una riacutizzazione della malattia IgG4-correlata che richieda l’avvio o la continuazione del trattamento con glucocorticoidi (GC) al momento del rilascio del consenso informato.
    6. Malattia IgG4-correlata che interessi almeno 2 organi/siti in qualsiasi momento nel corso della malattia IgG4-correlata con documentazione da confermare.
    7. Disponibilità e capacità di rispettare il protocollo, completare le valutazioni dello studio e completare il periodo dello studio.
    8. I soggetti di sesso maschile non sottoposti a sterilizzazione chirurgica sessualmente attivi con una partner di sesso femminile in età fertile devono utilizzare un preservativo con spermicida dal Giorno 1 fino alla conclusione dello studio e devono accettare di continuare a utilizzare tali precauzioni per almeno 6 mesi dopo la dose finale del prodotto sperimentale (IP). Le donne in età fertile devono presentare un test di gravidanza sierico negativo allo screening. Le donne in età fertile sessualmente attive con un partner maschile non sottoposto a sterilizzazione chirurgica devono utilizzare un metodo contraccettivo altamente efficace a partire dalla firma del consenso informato e devono acconsentire a continuare a utilizzare tali precauzioni fino alla fine del follow-up dello studio e almeno 180 giorni dopo l’ultima dose dell’IP; la cessazione della contraccezione dopo questo momento definito deve essere discussa con un medico responsabile. L’astinenza periodica, il metodo del ritmo e il coito interrotto non sono considerati metodi contraccettivi adeguati. Sarà fatta una raccomandazione affinché le partner di sesso femminile (in età fertile) dei partecipanti allo studio di sesso maschile utilizzino un metodo contraccettivo altamente efficace diverso da un metodo barriera.
    Le donne in età fertile sono definite come coloro che non sono state rese chirurgicamente sterili (ossia, la sterilizzazione chirurgica include legatura bilaterale delle tube, ooforectomia bilaterale o isterectomia) o coloro non in fase postmenopausale (definita come 12 mesi senza mestruazioni senza una causa medica alternativa e valori dell’ormone follicolo-stimolante rientranti nell’intervallo postmenopausale come stabilito dal laboratorio clinico).
    E.4Principal exclusion criteria
    1. Severe cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric
    2. History of solid organ or cell-based transplantation.
    3. Known immunodeficiency disorder.
    4. Active malignancy or history of malignancy that was active within the last 10 years, with exceptions (please see the protocol)
    5. Receipt of any biologic B cell-depleting therapy in the 6 months prior to screening.

    6. Receipt of non-depleting B-cell-directed therapy (eg, belimumab), abatacept, or other biologic immunomodulatory agent within 6 months prior screening.
    7. Receipt of non-biologic DMARD or immunosuppressive agent other than GCs (eg, azathioprine, mycophenolate mofetil, methotrexate, others) within 4 weeks prior to screening.
    8. Receipt of any investigational agent < 12 weeks or < 5 half-lives of the drug (whichever is longer) prior to screening.
    9. Inability to be tapered off of GC therapy by 8 weeks post-randomization, in the opinion of the Investigator.
    10. Receipt of live vaccine or live therapeutic infectious agent within the 2 weeks prior to screening.
    11. Pregnancy, lactation, or planning to become pregnant within 6 months of the last dose of IP.
    12. Positive test for, or prior treatment for, hepatitis B or HIV infection.
    13. History of untreated hepatitis C infection, or positive antibody test for hepatitis C virus (HCV)
    14. Evidence of active tuberculosis (TB) or being at high risk for TB
    15. History of > 1 episode of herpes zoster (any grade) and/or any other definite or probable opportunistic infection in the 12 months prior to screening
    16. Known history of allergy or reaction to any component of inebilizumab formulation or history of anaphylaxis to any human gamma globulin therapy.
    17. Allergy to or intolerance of protocol-required treatment, including medications for prophylaxis of infusion reactions
    18. Estimated glomerular filtration rate < 30 mL/min/1.73 m2 by Modification of Diet in Renal Disease Study (MDRD) equation (NIDDK).
    19. Blood tests at screening that meet any of the criteria reported in the protocol
    20. Subjects with the abnormal liver function tests in the absence of hepatobiliary IgG4-RD activity:
    OR
    Subjects with the abnormal liver function tests in the presence of hepatobiliary IgG4-RD activity:
    21. Anti-neutrophil cytoplasmic antibodies (ANCA) targeted against proteinase 3 or myeloperoxidase at the central laboratory.
    22. History of alcohol or drug abuse that, in the opinion of the Investigator, might affect patient safety or compliance with visits or interfere with safety or other study assessments.
    23. Active, clinically significant infection at the time of randomization (IP administration may be delayed until recovery, if within screening window, otherwise subject may be rescreened).
    24. Participation in any clinical trial that includes use of any pharmacologic intervention.
    1. Grave disturbo cardiovascolare, respiratorio, endocrino, gastrointestinale, ematologico, neurologico, psichiatrico o sistemico
    2. Anamnesi di trapianto di organo solido o cellule.
    3. Noto disturbo da immunodeficienza.
    4. Neoplasia attiva o anamnesi di neoplasie attive negli ultimi 10 anni, con eccezioni (vedi protocollo)
    5. Ricezione di qualsiasi terapia biologica di deplezione di cellule B nei 6 mesi precedenti lo screening.
    6. Ricezione di una terapia a base di cellule B non depletoria (ad es. belimumab), abatacept o altro agente immunomodulatore biologico entro 6 mesi precedenti lo screening.
    7. Ricezione di farmaci antireumatici modificatori della malattia (DMARD) non biologici o immunosoppressori diversi dai GC (ad es. azatioprina, micofenolato mofetile, metotrexato, altri) entro le 4 settimane precedenti lo screening.
    8. Ricezione di qualsiasi agente sperimentale <12 settimane o <5 emivite del farmaco (a seconda di quale sia il periodo più lungo) precedenti lo screening.
    9. Incapacità di interrompere la terapia a base di GC entro 8 settimane successive la randomizzazione, a giudizio dello sperimentatore.
    10. Ricevimento di vaccino vivo o agente infettivo terapeutico vivo entro 2 settimane precedenti lo screening.
    11. Gravidanza, allattamento al seno o pianificazione di una gravidanza entro 6 mesi dall’ultima dose dell’IP.
    12. Test positivo o precedente trattamento per infezione da virus dell’epatite B o virus dell’immunodeficienza umana (HIV).
    13. Anamnesi di infezione da epatite C non trattata o test anticorpale positivo per il virus dell’epatite C (HCV).
    14. Evidenza di tubercolosi (TB) attiva o ad alto rischio di TB
    15. Anamnesi di >1 episodio di herpes zoster (di qualsiasi grado) e/o qualsiasi altra infezione opportunistica certa o probabile nei 12 mesi precedenti lo screening
    16. Anamnesi nota di allergia o reazione a qualsiasi componente della formulazione di inebilizumab o anamnesi di anafilassi a qualsiasi terapia con immunoglobulina umana.
    17. Allergia o intolleranza al trattamento richiesto dal protocollo, compresi i farmaci per la profilassi delle reazioni all’infusione
    18. Velocità di filtrazione glomerulare stimata <30 ml/min/1,73 m2 utilizzando l’equazione della Modifica della dieta per lo studio della malattia renale (MDRD) (NIDDK).
    19. Esami del sangue allo screening che soddisfano i criteri specificati nel protocollo
    20. Soggetti che presentino test di funzionalità epatica anomali in assenza di attività epatobiliare nella malattia IgG4-correlata
    OPPURE
    Soggetti che presentino test di funzionalità epatica anomali in presenza di attività epatobiliare della malattia IgG4-correlata
    21. Anticorpi citoplasmatici antineutrofili (ANCA) mirati a proteinasi 3 o mieloperossidasi come da lettura del laboratorio centrale.
    22. Anamnesi di abuso di alcol o sostanze stupefacenti
    23. Infezione attiva clinicamente significativa al momento della randomizzazione
    24. Partecipazione a qualsiasi sperimentazione clinica che includa l’utilizzo di qualsiasi trattamento farmacologico.
    E.5 End points
    E.5.1Primary end point(s)
    Time to disease flare, defined as the time in days from Day 1 (dosing) to the date of the first treated and AC-determined IgG4 RD flare within the 52-week RCP. The date of disease flare is defined as the date of initiation of any flare treatment (new or increased GC treatment, other immunotherapy, or interventional procedure) deemed necessary by the Investigator for the flare.
    Tempo alla riacutizzazione della malattia, definito come periodo di tempo in giorni dal Giorno 1 (somministrazione) alla data della prima riacutizzazione di IgG4-RD trattata, determinata da un Comitato di validazione (AC), entro l’RCP di 52 settimane. La data della riacutizzazione della malattia è definita come la data di inizio di un qualsiasi trattamento (trattamento con GC nuovo o potenziato, altra immunoterapia o procedura interventistica) considerato necessario dallo Sperimentatore per ovviare alla riacutizzazione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52-week RCP
    52-settimane RCP
    E.5.2Secondary end point(s)
    Incidence of TEAEs, TESAEs, and treatment-emergent adverse events of special interest (AESIs) during the 52-week RCP and during the OLP.
    The incidence of ADAs directed against inebilizumab during the RCP.
    Annualized flare rate for treated and AC-determined flares during the RCP.
    Annualized flare rate for AC-determined flares, whether or not treated, during the RCP.
    The proportion of subjects achieving flare-free complete remission at
    Week 52. Complete remission is defined as an IgG4-RD Responder Index (RI, Wallace et al, 2018) score of 0 at Week 52, no AC-determined flare during the RCP, and no treatment for flare or disease control except the required 8-week GC taper.
    Time to initiation of first treatment (medication or procedure) for new or worsening disease activity by the Investigator within the RCP, regardless of AC determination of flare.
    Glucocorticoid use, calculated as the cumulative GC dose taken for the purpose of IgG4-RD disease control during the RCP.
    Incidenza degli eventi avversi, compresi quelli gravi e di particolare interesse, emergenti dal trattamento durante l’RCP di 52 settimane e durante l’OLP.
    L’incidenza di anticorpi anti-farmaco diretti contro inebilizumab durante l’RCP.
    Tasso di riacutizzazione annualizzato per le riacutizzazioni trattate e determinate dall’AC durante l’RCP.
    Tasso di riacutizzazione annualizzato per le riacutizzazioni determinate dall’AC, che siano trattate o meno, durante l’RCP.
    Percentuale di soggetti che ottengono una remissione completa senza riacutizzazione alla Settimana 52. La remissione completa è definita come un punteggio dell’indice di responder IgG4-RD pari a 0 alla Settimana 52, nessuna riacutizzazione determinata dall’AC durante l’RCP e nessun trattamento per la riacutizzazione o il controllo della malattia, ad eccezione della riduzione della dose di GC richiesta della durata di 8 settimane.
    Tempo all’inizio del primo trattamento (farmaco o procedura) per l’attività della malattia nuova o in peggioramento da parte dello Sperimentatore entro l’RCP, indipendentemente dalla determinazione della riacutizzazione da parte dell’AC.
    Uso di glucocorticoidi, calcolato come dose cumulativa di GC assunta ai fini del controllo della malattia IgG4-RD durante l’RCP.
    E.5.2.1Timepoint(s) of evaluation of this end point
    52-week RCP
    52-settimane RCP
    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 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    La seconda parte dello studio è opzionale e in aperto
    The second part of trial is optional and open label
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Canada
    China
    France
    Germany
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Spain
    Ukraine
    United Kingdom
    United States
    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
    The study will be complete when the last active subject completes the Day 365 visit of the OLP or discontinues the OLP
    Lo studio sarà concluso quando l'ultimo soggetto attivo completerà la visita al giorno 365 del periodo in aperto o sospenderà il periodo in aperto
    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 months6
    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 months6
    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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 200
    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)
    none
    nessuno
    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 Decision2020-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-16
    P. End of Trial
    P.End of Trial StatusOngoing
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