PACIFIC
Research type
Research Study
Full title
Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects with Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
IRAS ID
1006109
Contact name
Kristin Taylor
Contact email
Sponsor organisation
Escient Pharmaceuticals, Inc.
Eudract number
2021-002526-25
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to find out the safety and tolerability (the degree to which side effects affect a participant’s willingness to continue taking study drug) of the study drug EP547 in patients with itch associated with Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis (PSC) cholestatic liver disease and to determine the amount of EP547 in the blood after dosing.
Approximately 58 patients will take part in this study at a number of different locations in the United States (US), Canada, United Kingdom and other countries.
There are 9 visits to the clinic and most will be approx 1-2 hours to complete, but 2 visits may take up to 4 hours to complete depending on the procedures required. Study duration will be between 14 to 18 weeks.
For hybrid study sites, visits 3,4,5,7 & 9 may be conducted at participant home/work by a mobile nurse. In addition, a telehealth visit will be arranged for each visit conducted by a mobile nurse using technology (eg, smartphone or computer) so the study doctor and/or site staff can continue to monitor your health
There is a screening period of up to 4 weeks long, a 12-week treatment period, and a follow-up visit 2 weeks after
stopping study treatment. The treatment period is split into 2, Double blind (DB) & Open Label (OL). DB is visits 2-6 weeks and participants will be randomised to either 100mg EP547 or placebo treatment. Neither the participant or the study Dr will know which treatment is assigned (the study Dr can find out, if required). OL is visits 7-8 and all participants who have completed DB will receive open label 100mg doses of EP547.
The study drug will be provided in tablet form (2) which are to be taken whole, with water, after a fast of at least 7hrs.
Participants will be provided with additional study drug to be taken at home.REC name
London - Westminster Research Ethics Committee
REC reference
22/LO/0545
Date of REC Opinion
23 Sep 2022
REC opinion
Further Information Favourable Opinion