LUM001 and placebo with UDCA in patients with PBC - the CLARITY study

• Research type

  Research Study

• Full title

  A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi) in Combination with Ursodeoxycholic Acid (UDCA) in Patients with Primary Biliary Cirrhosis.

• IRAS ID

  131074

• Contact name

  David Jones

• Contact email

  David.Jones@newcastle.ac.uk

• Sponsor organisation

  Lumena Pharmaceuticals UK

• Eudract number

  2013-000482-36

• ISRCTN Number

  N/A

• Research summary

  This is a Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi) in Combination with Ursodeoxycholic Acid (UDCA) in Patients with Primary Biliary Cirrhosis (PBC) - the CLARITY study. Approximately 60 patients (2 dose cohorts; 30 patients per cohort will be randomised 2 active to 1 placebo in each cohort) are planned for randomization to treatment in this study.
  LUM001 can stop bile acids from being absorbed from the gut into the body. It can lower the amount of bile acids in the blood and may reduce itching in people with primary biliary cirrhosis.

  This research study is looking to see if LUM001 can help treat itching in patients who are already taking Ursodeoxycholic Acid (UDCA) and also looking at whether LUM001 can help improve the liver enzymes and the quality of PBC patients’ sleep.

  Finally the study will look at how safe LUM001 is in patients with PBC and how well it can be tolerated.

• REC name

  North East - York Research Ethics Committee

• REC reference

  13/NE/0177

• Date of REC Opinion

  8 Jul 2013

• REC opinion

  Further Information Favourable Opinion