A Phase 2 Study of Seladelpar in Adult Patients with PSC
Research type
Research Study
Full title
A Phase 2, Randomized, Double Blind, Placebo Controlled, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of Seladelpar Administered for 24 Weeks in Adult Patients with Primary Sclerosing Cholangitis (PSC)
IRAS ID
265936
Contact name
Douglas Thorburn
Contact email
Sponsor organisation
CymaBay Therapeutics
Eudract number
2019-001760-30
Clinicaltrials.gov Identifier
142198, Investigational New Drug
Duration of Study in the UK
1 years, 8 months, 0 days
Research summary
The purpose of this research study is to determine if the study drug, seladelpar, is safe and effective in treating patients with Primary Sclerosing Cholangitis (PSC).
PSC is a disease that attacks part of liver called the bile ducts and can cause injury to the liver by slowly damaging these small tubes.
This randomised (selected by chance), double-blind (treatment received in study remains unknown to study doctor and participant), placebo-controlled (commonly known as 'sugar pill' that does not contain seladelpar) study may last up to 36 weeks. This study requires 10 to 11 scheduled clinic visits over the 36 weeks period(approximately 238 days) The participants may be offered enrolment into a separate optional study where all patients will get the study drug for an additional 52 weeks. During the study, the participant will receive one of the three doses of seladelpar or placebo.
to be considered eligible in this trial, participants need to be adult (18 years of age or older) with confirmed diagnosis of PSC and meet the required laboratory parameters during the Screening.
As part of this study, there are several procedures that will be done to look at liver and gut health. None of which are x-rays and, therefore, do not use any radiation. FibroScan is a machine with a probe (a tool about the size of a flashlight) that is rubbed across the outside of stomach area which uses sound waves and can help determine the amount of scarring of the participant's liver.
Magnetic resonance cholangiopancreatography (MRCP) and magnetic resonance imaging (MRI) are two types of scans that take detailed pictures of the liver, bile ducts to help see the severity of participant's PSC.
If the participant has been diagnosed with inflammatory bowel disease (IBD, colonoscopy procedure will be required to look for any signs of colon cancer.REC name
London - Central Research Ethics Committee
REC reference
19/LO/1301
Date of REC Opinion
11 Oct 2019
REC opinion
Further Information Favourable Opinion