ASSURE: A long-term study of Seladelpar in Subjects with PBC
Research type
Research Study
Full title
ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
IRAS ID
291022
Contact name
David Jones
Contact email
Sponsor organisation
CymaBay Therapeutics, Inc.
Eudract number
2020-005198-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Primary biliary cholangitis (PBC) is a disease which causes inflammation of the tubes/ducts which carry bile in the liver. This subsequentially causes a build-up of toxic bile acids. This build-up is known as cholestasis and is one of the main characteristics of PBC. Increase of toxic bile acids can lead to fibrosis, cirrhosis and eventually liver failure. The most common symptoms of PBC are fatigue (feeling tired) and pruritus (itching). Successful treatment of PBC reduces the build-up of toxic bile acids in the liver and its associated symptoms.
Current treatment options for PBC include Ursodeoxycholic acid (UDCA) and obeticholic acid. However, many patients with PBC do not respond adequately to these treatment options. As such, alternative treatments are required for the long-term treatment of PBC.
The study drug being tested is seladelpar. In previous human studies, seladelpar decreased cholestasis and improved pruritus. Previous study results indicate seladelpar is generally safe and well tolerated.
This study will evaluate the safety and tolerability of seladelpar over approximately 5 years. The study will last approximately 5 years or until seladelpar’s first commercial approval or the program is discontinued (whichever comes first). Participants will need to have 17 visits to the study site over the 5 years. In addition, some questionnaires will need to be completed every day, depending on the stage of the study.
The study is open label, so the researchers and participants will know the treatment pathway. Participants may only join this research study if they previously participated in a study of seladelpar for patients with PBC and said study allows rollover into this study.
Procedures involved include physical exams, vital signs, blood samples, ECGs, questionnaire completion, liver elastography, abdominal ultrasounds and liver biopsies. The study is sponsored by CymaBay Therapeutics, Inc.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
21/NW/0112
Date of REC Opinion
1 Jun 2021
REC opinion
Further Information Favourable Opinion