GLISTEN: Linerixibat for PBC patients with cholestatic pruritus

• Research type

  Research Study

• Full title

  A two-part, randomized, placebo controlled, double blind, multicenter, Phase 3 study to evaluate the efficacy and safety of linerixibat for the treatment of cholestatic pruritus in participants with primary biliary cholangitis (PBC).

• IRAS ID

  298975

• Contact name

  David Jones

• Contact email

  david.jones@newcastle.ac.uk

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2021-000007-21

• Duration of Study in the UK

  1 years, 8 months, 1 days

• Research summary

  The study funded by GSK, is part of an ongoing evaluation of the effectiveness, safety and tolerability of linerixibat for the treatment of moderate to severe pruritus in adults with primary biliary cholangitis (PBC).

  PBC is a rare condition where the bile ducts in the liver become damaged. This causes the build-up of bile acid salts in the body which may lead to patients experiencing persistent itching (pruritus). Current pruritus treatments show limited effectiveness, have some unpleasant side-effects and interact with one of the main treatments for PBC, ursodeoxycholic acid (UDCA).

  Linerixibat restricts reabsorption of bile acids in the bowel, increasing their excretion, which may lessen pruritus. It’s hoped lower bile acid levels in the liver may improve the underlying disease.

  Globally, approximately 230 participants will be involved, with about 10 participants in the UK. Study participants will be divided into two groups. One group will receive linerixibat and one group will receive placebo. During different parts of the study, participants may be in different groups, but neither the study team nor the participants will know which study treatment they are receiving. Both the linerixibat and the placebo are given as a tablet, taken twice a day.

  Study participants will spend approximately 42 weeks in the study; a 6-8 week screening period, followed by a 32 week treatment period and then a 2 week follow-up period. Participants will be permitted to continue using certain pre-existing PBC treatments and itch relieving remedies at a stable dose, but changes in medication during the study are not permitted.

  Study assessments include:
  - Medical history
  - Physical examination
  - Urine pregnancy test (if applicable)
  - ECG
  - Blood tests
  - Stool test
  - Fibroscan (liver ultrasound – some centres only)
  - Electronic diary completed daily to record itch, sleep and fatigue
  - Questionnaires

• REC name

  Wales REC 2

• REC reference

  21/WA/0219

• Date of REC Opinion

  21 Jul 2021

• REC opinion

  Favourable Opinion