LUM001 in patients with Primary Sclerosing Cholangitis (CAMEO study)

• Research type

  Research Study

• Full title

  A Pilot, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients with Primary Sclerosing Cholangitis.

• IRAS ID

  172117

• Contact name

  Ciara Kennedy

• Contact email

  cikennedy@shire.com

• Sponsor organisation

  Lumena Pharmaceuticals UK

• Eudract number

  2014-005558-21

• Duration of Study in the UK

  1 years, 8 months, 10 days

• Research summary

  This is a safety and tolerability study in adults with Primary Sclerosing Cholangitis (PSC) designed to evaluate the effects of daily dosing with LUM001 for 14 weeks, which includes a 6 week dose escalation period up to a dose of 10 mg per day and an 8 week stable dosing period. Approximately 20 subjects will be enrolled on this study. Patients participation in the study is expected to last 5 months.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  15/LO/0246

• Date of REC Opinion

  25 Mar 2015

• REC opinion

  Further Information Favourable Opinion