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    EudraCT Number:2019-003158-10
    Sponsor's Protocol Code Number:212358
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-11-09
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2019-003158-10
    A.3Full title of the trial
    Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Linerixibat Long-term Safety and Tolerability Study
    A.3.2Name or abbreviated title of the trial where available
    Long-term safety&tolerability of GSK2330672 as a treatment for cholestatic pruritus participants PBC
    A.4.1Sponsor's protocol code number212358
    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 SponsorGlaxoSmithKline Research & Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline LLC
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportGlaxoSmithKline Research & Development Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street Address980 Great West Road
    B.5.3.2Town/ cityBrentford, Middlesex
    B.5.3.3Post codeTW8 9GS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 800 783 9733
    B.5.5Fax numberNot Applicable
    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 namelinerixibat (GSK2330672) 45mg
    D.3.2Product code GSK2330672
    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 INNLinerixibat
    D.3.9.1CAS number 1345982-69-5
    D.3.9.2Current sponsor codeGSK2330672
    D.3.9.4EV Substance CodeSUB194569
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC)
    E.1.1.1Medical condition in easily understood language
    Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC)
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10064190
    E.1.2Term Cholestatic pruritus
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10080429
    E.1.2Term Primary biliary cholangitis
    E.1.2System Organ Class 10019805 - Hepatobiliary 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 safety and tolerability of long-term linerixibat treatment in participants with cholestatic pruritus in PBC
    E.2.2Secondary objectives of the trial
    -To characterize the effects of long-term linerixibat treatment on disease burden and health related QOL in participants with
    cholestatic pruritus in PBC

    -To characterize the effects of long-term linerixibat treatment in PBC population

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all the following criteria apply:
    1. Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent in the participant’s parent trial BAT117213 or 201000
    Type of Participant and Disease Characteristics
    2. Participants with a diagnosis of PBC and a history of associated pruritus as evidenced by randomization into a prior eligible linerixibat clinical trial(BAT117213 or 201000)
    3. Participants must have completed the main treatment period in a prior eligible linerixibat clinical trial (BAT117213 or 201000)
    4. Male or female
    Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Contraception by male participants or male partners of female participants is not required in this protocol
    a. Female Participants:
    -A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
    o Is not a woman of childbearing potential (WOCBP)
    o Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, as described in [Appendix 4] of Protocol, during the intervention period and for at least 4 weeks, after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention
    o A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention
    o If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
    -Additional requirements for pregnancy testing during and after study intervention are listed in [Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information] of Protocol
    -The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy
    -Informed Consent
    5. Capable of giving signed informed consent as described in [Appendix 1] of protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    Medical Conditions
    1. Screening total bilirubin >2x ULN. Total bilirubin >2x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%
    2. Screening ALT or aspartate aminotransferase (AST) >6x ULN
    3. Screening estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m² based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
    4. History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy or ascites)
    5. Presence of actively replicating viral hepatitis B or C (HBV, HCV) infection and/or confirmed hepatocellular carcinoma or biliary cancer
    Note: Other hepatic conditions (e.g., primary sclerosing cholangitis (PSC), alcoholic liver disease, autoimmune hepatitis, non-alcoholic steatohepatitis [NASH] are permitted if PBC is the dominant liver injury in the investigator’s opinion
    6. Recent or current clinically significant diarrhea in the Investigator’s medical opinion
    7. Current symptomatic cholelithiasis or inflammatory gallbladder disease is exclusionary. Participants with history of cholecystectomy ≥3 months before screening may be eligible for enrollment
    8. Current diagnosis or previous diagnosis of colorectal cancer
    9. Any current medical condition (e.g. psychiatric disorder, senility or dementia), which may affect the participant’s ability to comply with the protocol specified procedures
    Prior/Concomitant Therapy
    10. Use of Obeticholic acid: within 8 weeks prior to the date of the screening visit and may not restart until after the end of the study or study withdrawal. [Rationale: The potential for a Drug-Drug Interaction (DDI) between obeticholic acid and linerixibat has not been determined. A DDI study assessing the concomitant use of OCA and linerixibat is planned and depending on those results this OCA exclusion may be removed]
    11. Administration of any other IBAT inhibitor in the 1 month prior to screening
    [Rationale: Effects of another IBAT inhibitor may confound interpretation of the linerixibat safety and tolerability profile]
    Prior/Concurrent Clinical Study Experience
    12. Current enrollment or participation in any other clinical study (except for 201000)
    involving an investigational study treatment within 8 weeks prior to the screening visit
    Note: For participants coming from the 201000 study there is no specified waiting period before enrollment into this safety study.
    Diagnostic assessments
    13. QTc >480 msec
    NOTES: The QTc is the QT interval corrected for heart rate according to Bazett’s formula (QTcB), Frederica’s formula (QTcF), and/or another method. It is either machine-read or manually over-read
    The specific formula used to determine eligibility and discontinuation for an individual participant should be determined prior to initiation of the study and maintained for individual participants throughout study participation. The specific QT correction formula used must be specified in the eCRF
    A QTc >480 msec (12-lead ECG) at screening is exclusionary
    Note: The QT interval will be assessed at screening and at each long visit (yearly) by 12-Lead ECG. QTc stopping criteria are established for this study and are detailed in [Section 7.1.2] of Protocol
    Other Exclusions
    14. History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 measure (25 mL) of spirits
    E.5 End points
    E.5.1Primary end point(s)
    Frequency and severity of adverse events
    E.5.1.1Timepoint(s) of evaluation of this end point
    From start of treatment (Day1) to follow up phone call (Day 7 to 14 post-final dose of IP). Assessments are made on Day 1, Week 1, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42, Month 48 and final follow phone call on Day 7 to Day 14 post final dose of IP.
    E.5.2Secondary end point(s)
    1.Change in domain scores of the PBC-40 over time
    2.Change in health-related QoL by the EQ-5D-3L summary index number (utility) over time
    3.Change in the EQ VAS (within the EQ-5D-3L) over time
    4.Change in the BDI-II over time

    5.Trends in clinically meaningful laboratory values including liver parameters and lipids over time
    E.5.2.1Timepoint(s) of evaluation of this end point
    For secondary endpoints numbers 1-4 the timepoints of evaluation are:
    From start of treatment (Day 1) until the final study visit (approximately Month 48). Assessments are made on Day 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24,Month 30, Month 36, Month 42 and Month 48.

    For secondary endpoint number 5 the timepoints of evaluation are:
    From start of treatment (Day 1) until the final study visit (approximately Month 48). Assessments are made on Day 1, Month 3, Month 6, Month 9, Month 12, Month 24, Month 36 and Month 48.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic 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 Yes
    E.6.13.1Other scope of the trial description
    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. 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 65
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 31
    F.4.2.2In the whole clinical trial 75
    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)
    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 Decision2021-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-14
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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