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    Summary
    EudraCT Number:2018-003365-34
    Sponsor's Protocol Code Number:I4V-MC-JAIV
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-08-03
    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 number2018-003365-34
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Primary Biliary Cholangitis Who Have an Inadequate Response or are Intolerant to UDCA.
    Studio randomizzato, in doppio cieco, controllato verso placebo, “proof-of-concept”, finalizzato a valutare l’efficacia e la sicurezza di baricitinib (LY3009104) nei pazienti affetti da colangite biliare primitiva (CBP) che presentano una risposta inadeguata o un’intolleranza all’acido ursodesossicolico (UDCA).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA.
    Uno studio di Baricitinib (LY3009104) in partecipanti con colangite biliare primitiva (CBP) che non rispondono o non possono prendere (UDCA).
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberI4V-MC-JAIV
    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 SponsorELI LILLY & COMPANY, LILLY CORPORATE CENTER
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    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.3.1Product nameOlumiant
    D.3.2Product code [LY3009104]
    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.3.9.2Current sponsor codeLY3009104
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit IU/mg international unit(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeLY3009104
    D.3.10 Strength
    D.3.10.1Concentration unit 1X 100 milligrams/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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: 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 Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    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.3.1Product nameOlumiant
    D.3.2Product code [LY3009104]
    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.3.9.2Current sponsor codeLY3009104
    D.3.9.3Other descriptive namebaricitinib
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit IU/mg international unit(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Biliary Cholangitis
    Colangite Biliare Primitiva
    E.1.1.1Medical condition in easily understood language
    Primary Biliary Cirrhosis
    Cirrosi Biliare Primitiva
    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 10008604
    E.1.2Term Cholangitis
    E.1.2System Organ Class 10019805 - Hepatobiliary 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 evaluate the effect of baricitinib 4-mg QD compared to placebo on PBC disease
    Valutare l’effetto di baricitinib 4 mg QD rispetto al placebo nel trattamento della colangite biliare primitiva (CBP)
    E.2.2Secondary objectives of the trial
    To evaluate the effect of baricitinib 2-mg QD compared to placebo on PBC disease
    To evaluate the effect of baricitinib 4-mg and 2-mg QD compared to placebo on PBC symptoms
    Valutare l’effetto di baricitinib 2 mg QD rispetto al placebo nel trattamento della colangite biliare primitiva (CBP)
    Valutare l’effetto di baricitinib 4 mg e 2 mg QD rispetto al placebo nel trattamento dei sintomi della colangite biliare primitiva (CBP)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Type of Patient and Disease Characteristics
    [1] Male or female patients who are at least 18 years of age.
    [2] Have a diagnosis of PBC (consistent with American Association for
    the Study of Liver Disease [AASLD] and European Association for Study
    of the Liver [EASL]
    Practice Guidelines; [Lindor 2009; EASL 2017]), as demonstrated by the
    presence of at least 2 of the following 3 diagnostic factors:
    ¿ History of elevated ALP levels for at least 6 months
    ¿ Positive antimitochondrial antibodies titer
    ¿ Liver biopsy consistent with PBC
    [3] Have ALP =1.67 x ULN but <6 x ULN
    [4] Taking UDCA for at least 52 weeks (stable dose for at least 12
    weeks) prior to Visit 3
    (Week 0), or have previously taken, but are intolerant (in the opinion of
    the investigator) to UDCA and have not received UDCA for at least 12
    weeks
    prior to Visit 3 (Week 0).
    Patient Characteristics
    [5] Nonpregnant, nonbreastfeeding female patients of childbearing
    potential:
    a. Patients who are abstinent (if this is complete abstinence, as their
    preferred and usual lifestyle) or in a same-sex relationship (as part of
    their
    preferred and usual lifestyle) must agree to either remain abstinent or
    stay in a same-sex relationship without sexual relationships with the
    opposite sex during the entirety of the study and for at least 1 week
    following the last dose of investigational product.
    Total abstinence is defined as refraining from intercourse during the
    entirety of the study and for at least 1 week following the last dose of
    investigational product. Periodic abstinence such as calendar, ovulation,
    symptothermal, postovulation methods, and withdrawal are not
    acceptable methods of contraception b. Otherwise, patients must agree
    to use for the entirety of the study and for at least 1 week following the
    last dose of investigational product, 2
    effective methods of contraception, where at least 1 form is highly
    effective (such as combination oral contraceptives, implanted
    contraceptives or
    intrauterine devices). Effective contraception (such as male or female
    condoms with
    spermicide, diaphragms with spermicide or cervical sponges) may be
    used as the second therapy. Barrier protection methods without
    concomitant
    use of a spermicide are not a reliable or acceptable method.
    Female patients of nonchildbearing potential may participate without
    requirements for contraception. This includes female patients who are:
    a. Infertile due to surgical sterilization (hysterectomy, bilateral
    oophorectomy,
    or tubal ligation), congenital anomaly such as mullerian agenesis; or
    b. Postmenopausal – defined as either
    i. A woman at least 50 years of age with an intact uterus, not on
    hormone therapy, who has had either
    1. Cessation of menses for at least 1 year, or
    2. At least 6 months of spontaneous amenorrhea with a
    follicle-stimulating hormone (FSH) >40 mIU/mL; or
    ii. A woman 55 years of age or older not on hormone therapy, who
    has had at least 6 months of spontaneous amenorrhea; or
    iii. A woman at least 55 years of age with a diagnosis of menopause
    prior to starting hormone replacement therapy.
    Uomini o donne con almeno 18 anni di età
    Pazienti con diagnosi di CBP (in accordo con American Association for
    the Study of Liver Disease [AASLD] e European Association for Study
    of the Liver [EASL]
    Linee Guida [Lindor 2009; EASL 2017]), come dimostrato dalla presenza di almeno 2 dei seguenti 3 fattori diagnostici:
    Livelli di ALP elevate per almeno sei mesi
    titolo anticorpale antimitocondriale positivo
    Biopsia del fegato consistente con diagnosi di CBP
    livelli di ALP =1.67 x ULN ma <6 x ULN
    aver assunto UDCA per almeno 52 settimane (a dose stabile per almeno 12 settimane) prima della Visita 3
    (Week 0), o aver precedentemente assunto, ma essere intollerante (secondo il medico) agli UDCA e non aver assunto UDCA per almeno 12 settimane prima della visita 3 (settimana zero)
    Donne in età fertile non devono rimanere incinta o allattare al seno
    Donne in menopausa
    E.4Principal exclusion criteria
    [7] History or presence of other concomitant liver diseases including:
    a. Hepatitis C virus (HCV) infection (hepatitis C antibody-positive and
    HCV ribonucleic acid [RNA] positive). ¿ Note: Patients who have
    documented anti-HCV treatment for a past HCV infection AND are HCV
    RNA-negative with a sustained viral response may be enrolled in the
    study.
    b. Hepatitis B virus (HBV) infection defined as:
    ¿ positive for hepatitis B surface antigen (HBsAg), or
    ¿ positive for hepatitis B core antibody (HBcAb)
    c. Primary sclerosing cholangitis
    d. Alcoholic liver disease
    e. Autoimmune liver disease other than PBC, such as overlap hepatitis
    f. Nonalcoholic steatohepatitis
    g. Gilbert's syndrome
    [8] Presence of clinical complications of PBC or clinically significant
    hepatic decompensation, including:
    a. Liver transplantation, current placement on a liver transplant list or
    current Model for End Stage Liver Disease (MELD) score = 15
    b. Portal hypertension with complications, including known gastric or
    esophageal varices, ascites, history of variceal bleeds or related
    therapeutic
    or prophylactic interventions (e.g., beta blockers, insertion of variceal
    bands or transjugular intrahepatic portosystemic shunt), or hepatic
    encephalopathy
    c. Cirrhosis, including history or presence of one or more of the
    following: spontaneous bacterial peritonitis, hepatocellular carcinoma
    d. Hepatorenal syndrome (type I or II)
    [9] Have an estimated glomerular filtration rate (eGFR) based on the
    most recent available serum creatinine of <90 mL/min/1.73 m2.
    [10] Have screening electrocardiogram (ECG) abnormalities that in the
    opinion of the investigator or the sponsor are clinically significant and
    indicate an unacceptable risk for the patient's participation in the study.
    Anamnesi o presenza di altre patologie epatiche concomitanti come:
    infezione da virus dell'epatite C (anticorpi positivi all'epatite C e positività a HCV acido ribonucleico).
    infezioni da virus dell'epatite B definita come:
    positività per antigene di superficie epatite B (HBsAg), o positività per anticorpi core B (HBcAb)
    Colangite sclerosante primitiva
    Malattia epatica alcolica
    Malattie epatiche autoimmuni
    steatoepatite non alcolica
    sindrome di Gilbert
    presenza di complicazioni cliniche di CBP o scompenso epatico
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in ALP
    Variazione rispetto al basale del livello ALP
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 12
    settimana 12
    E.5.2Secondary end point(s)
    Proportion of patients with ALP <1.67 x ULN (and at least 15% decrease from baseline) and total bilirubin<ULN
    Change from baseline in itch as measured by Itch NRS
    Change from baseline in fatigue as measured by Fatigue NRS
    Percentuale di pazienti con ALP <1,67 x ULN (e calo di almeno il 15% rispetto al basale) e bilirubina totale < ULN
    Variazione del prurito rispetto al basale, misurato secondo il punteggio NRS relativo al prurito
    Variazione dell’affaticamento rispetto al basale, misurato secondo il punteggio NRS
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    settimana 12
    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 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 EEA7
    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
    United States
    Italy
    United Kingdom
    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 years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    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: 52
    F.1.3Elderly (>=65 years) No
    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 18
    F.4.2.2In the whole clinical trial 52
    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)
    Baricitinib will not be made available to patients after conclusion of the study.
    Baricitinib non sarà reso disponibile ai pazienti dopo la conclusione dello 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 Decision2019-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
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