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
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.
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