Phase 2 study of OCA in patients with PBC

• Research type

  Research Study

• Full title

  A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid

• IRAS ID

  270397

• Contact name

  David Jones

• Contact email

  David.Jones@ncl.ac.uk

• Sponsor organisation

  Intercept Pharmaceuticals, Inc.

• Eudract number

  2018-002575-17

• Duration of Study in the UK

  1 years, 7 months, 30 days

• Research summary

  The main purpose of this study is to assess the effects of the combination of obeticholic acid (OCA) and 2 different doses of Bezafibrate, compared with OCA alone, in participants with Primary Biliary Cholangitis who had an inadequate response or who were unable to tolerate ursodeoxycholic acid (UDCA).

  Approximately 54 participants are expected to take part in this study globally (Europe and the Asia-Pacific region), at approximately 30 centres. The trial is divided into three phases, a Screening phase, a double-blind Treatment phase, and a Long-Term Safety Evaluation phase. Participants will spend approximately 1.5 years on the study.

  Participants can expect to make two screening visits, at least 5 Treatment visits, and up to 6 long–Term Safety Evaluation visits.

  Participants will be assigned to one of three treatment groups, at random. The chance of being assigned to a particular treatment group is 1 in 3. In all treatment groups, participants will receive OCA. Approximately 18 participants will be assigned to each of the following treatment groups:
  • Group A: OCA + Placebo, 2 tablets taken once a day.
  • Group B: OCA + Placebo + Bezafibrate 200 mg, taken once a day.
  • Group C: OCA + Placebo + Bezafibrate 400 mg, taken once a day.

  From Day 1, for 4 weeks, participants will receive 5 mg OCA daily, and from the Week 4 visit the dose will be increased to 10 mg OCA daily, until the end of the participant’s involvement in the study. Participants will need to have fasted for at least 8 hours before each Treatment or Long-Term Safety Evaluation visit.

  Participants will be contacted by phone on 3 occasions, to check on their health and any medicines they are taking, or have taken since their last visit.
  Summary of results
  What was the change in the amount of ALP in the bloodstream after 12 weeks of treatment?
  Researchers measured ALP levels at the beginning of the double-blind period and again after treatment for 12 weeks. All 4 treatment groups showed ALP levels went down from before treatment started.
  This does not mean that everyone in this study had these results, and individual results could be better or worse than the overall group. Other studies may have different results. These are just some of the main results of this study
  

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  19/EM/0357

• Date of REC Opinion

  14 Feb 2020

• REC opinion

  Further Information Favourable Opinion