A Study of GSK2330672 for the Treatment of Itching in Patients with Primary Biliary Cholangitis

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 16-010096
    NCT ID: NCT02966834
    Sponsor Protocol Number: 201000

About this study

The purpose of this study is to evaluate the effectiveness, safety and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in patients who have primary biliary cholangitis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Must be age 18 to 80 years inclusive, at the time of signing the informed consent
  • Has proven Primary biliary cholangitis, as demonstrated by having at least 2 of the following
    • History of sustained increased ALP levels >ULN first recognized at least 6 months prior to the Screening Visit
      • Sustained ALP elevations at the time of screening is not required, recognizing that the ALP may have decreased after institution of ursodeoxycholic acid (UDCA) therapy 
    • Documented positive anti-mitochondrial antibody (AMA) titer >1:40 titer on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay
    • PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive)
    • Liver biopsy (at any time in the past) consistent with PBC
  • Itch severity must be rated as being ≥ 4 on a 0 to 10 point scale for the majority of time during the 8 weeks prior to the screening visit
  • If currently taking UDCA, should be on stable doses of UDCA for > 8 weeks at time of screening
  • If not taking UDCA due to intolerance, may be enrolled 8 weeks after the last dose of UDCA
    • No changes or discontinuation is permitted until completion of the Main Study Period
  • Male or female
    • Female may not be pregnant, breastfeeding, and at least one of the following conditions 
      • Not of childbearing potential
      • Agrees to follow contraceptive guidance during treatment period and until at least 4 weeks after the last dose of study treatment
  • Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form and protocol

Exclusion Criteria

  • Screening total bilirubin >1.5x ULN
    • Isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%
  • Screening ALT or AST >4x ULN
  • Screening eGFR <45 milliliter (mL)/minute/1.73 meter squared (m^2) based on the CKD-EPI
  • History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy or ascites)
  • History or presence of other concomitant liver diseases including hepatitis due to hepatitis B or C virus (HBV, HCV) infection, primary sclerosing cholangitis (PSC), alcoholic liver disease, definite autoimmune hepatitis, biopsy proven nonalcoholic steatohepatitis (NASH) or confirmed hepatocellular carcinoma
  • Current symptomatic inflammatory bowel disease, chronic diarrhea, Crohn's disease or diarrhea related to malabsorption syndromes
  • Current symptomatic cholelithiasis or inflammatory gall bladder disease
    • History of cholecystectomy ≥ 3 months before screening may be eligible for enrollment
  • Any current medical condition (e.g. psychiatric disorder, senility or dementia), which may affect ability to comply with protocol specified procedures
  • Administration of the following drugs at any time during the 3 months prior to screening for the study or planned administration during the study
    • Colchicine
    • Methotrexate
    • Azathioprine
    • Systemic corticosteroids
  • Initiation or increase in dose of bezafibrate or fenofibrate at any time during the 3 months prior to screening
    • Study may be joined on stable doses of these medications, but no change or discontinuation is permitted until completion of the main study period
  • Initiation or increase in dose of any of the following in the 8 weeks prior to screening
    • Rifampicin
    • Naltrexone
    • Naloxone
    • Nalfurafine
    • Sertraline
      • Study may be joined on stable or decreased doses of these medications, but no change in dose is permitted until completion of the main study period
  • Bile acid binding resin use
    • Must discontinue use of cholestyramine, colesevelam, colestipol or colestimide prior to the start of initial study period, no later than day-2
      • These drugs may be administered after completion of the main study period, if clinically indicated
  • Obeticholic acid use must be discontinued at least 8 weeks prior to the start of the initial study period and may not restart until after the end of the study
  • Current enrolment or participation within the 8 weeks before start of the initial study period, in any other clinical study involving an investigational study treatment
  • QT interval corrected for heart rate QTc >450 millisecond (msec) or QTc >480 msec in bundle branch block
  • History of sensitivity to the study treatment or components or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates participation in the study
  • 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 gram of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 measure (25 mL) of spirits

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Elizabeth Carey, M.D.

Open for enrollment

Contact information:

Kelly Clark CCRP

(480)342-2536

Clark.Kelly2@mayo.edu

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CLS-20318102

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