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    Summary
    EudraCT Number:2018-003365-34
    Sponsor's Protocol Code Number:I4V-MC-JAIV
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-02-11
    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 ConcernedUK - MHRA
    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
    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
    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 and Company
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    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 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 nameOlumiant
    D.3.2Product code LY3009104
    D.3.4Pharmaceutical form Film-coated 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 INNBARICITINIB
    D.3.9.3Other descriptive namebaricitinib
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 Film-coated 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 INNBARICITINIB
    D.3.9.3Other descriptive namebaricitinib
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 placeboFilm-coated tablet
    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 placeboFilm-coated tablet
    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
    E.1.1.1Medical condition in easily understood language
    Primary Biliary Cirrhosis
    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
    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
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects will be eligible for randomization only if they meet all of the
    following criteria within the screening period, which is ≤49 days prior to randomization, unless
    specifically defined:
    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.
    E.4Principal exclusion criteria
    Medical Conditions
    [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.

    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in ALP
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 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
    E.5.2.1Timepoint(s) of evaluation of this end point
    at Week 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 concerned3
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Italy
    United Kingdom
    United States
    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
    End of the study is the date of the last visit or last scheduled procedure shown in the Schedule of Activities (Section 2) for the last patient
    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 state6
    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.
    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 Decision2019-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-26
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