Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)

Conditions

Primary Biliary Cirrhosis

Keywords

PBC, Primary Biliary Cholangitis (PBC)

Brief summary

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

Detailed description

Primary: To evaluate the long-term safety and tolerability of seladelpar Secondary: * To evaluate the long-term efficacy of seladelpar * To evaluate the effect of seladelpar on patient-reported outcomes (pruritus)

David Jones, Emily Combe, Harun Knight, Vicki Laskier-Owens, Shijie Ren et al. (8 authors)

Journal of Comparative Effectiveness Research2026-04-17

10.57264/cer-2025-0206

EFFICACY AND SAFETY OF SELADELPAR IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS PREVIOUSLY TREATED WITH FIBRATES OR OBETICHOLIC ACID

A. Villamil, D. K. Pratt, Andreas E. Kremer, Vincenza Calvaruso, Elena Gómez Dominguez et al. (10 authors)

Annals of Hepatology2025-09-01

10.1016/j.aohep.2025.102051

Long-Term Efficacy and Safety of Selective PPARδ Agonist Seladelpar in Primary Biliary Cholangitis: ASSURE Interim Study Results

Cynthia Levy, Palak Trivedi, Kris V. Kowdley, Stuart C. Gordon, Christopher L. Bowlus et al. (22 authors)

The American Journal of Gastroenterology2025-06-243 citations

10.14309/ajg.0000000000003603

OP-1 LONG-TERM EFFICACY AND SAFETY OF OPEN-LABEL SELADELPAR TREATMENT IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS: INTERIM 2-YEAR RESULTS FROM THE ASSURE STUDY

Palak Trivedi, Cynthia Levy, Kris V. Kowdley, Stuart C. Gordon, Christopher L. Bowlus et al. (29 authors)

Annals of Hepatology2024-12-011 citations

10.1016/j.aohep.2024.101599

Open‐label, clinical trial extension: Two‐year safety and efficacy results of seladelpar in patients with primary biliary cholangitis

Marlyn J. Mayo, John M. Vierling, Christopher L. Bowlus, Cynthia Levy, Gideon M. Hirschfield et al. (23 authors)

Alimentary Pharmacology & Therapeutics2023-10-3031 citations

10.1111/apt.17755

Interventions

DRUGSeladelpar 5 mg Capsule

Participants will be assigned to a treatment group if tolerability issues noted in the previous study.

DRUGSeladelpar 10 mg Capsule

Participants will be assigned to a treatment group unless there are tolerability issues.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

1. Must have given written informed consent (signed and dated) 2. Participated in a PBC study with seladelpar 3. Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose

Design outcomes

Primary

Measure	Time frame
Treatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results	Through study completion, up to 60 Months

Secondary

Measure	Time frame	Description
Death	60 Months	Occurrence of overall death
Liver transplantation	60 Months	Occurrence of overall liver transplantation
Change in MELD	60 Months	MELD score ≥ 15 for at least 2 consecutive visits
Ascites	60 Months	Occurrence of overall ascites requiring treatment
Hospitalization for variceal bleeding	60 Months	Hospitalization for new onset, or recurrence, of variceal bleeding
Hospitalization for hepatic encephalopathy	60 Months	Hospitalization for new onset, or recurrence, hepatic encephalopathy (as defined by a West Haven score ≥ 2)
Hospitalization for spontaneous bacterial peritonitis	60 Months	Hospitalization for new onset, or recurrence, spontaneous bacterial peritonitis (confirmed by culture from diagnostic paracentesis)
Response on composite endpoint	60 Months	Alkaline phosphate (ALP)
Normalization of ALP	60 Months	Proportion of subjects with normalization of ALP
Laboratory Value: Serum Alkaline Phosphatase (ALP)	Through study completion, up to 60 Months	Serum Alkaline Phosphatase (ALP)
Laboratory Value: Aspartate Aminotransferase (AST)	Through study completion, up to 60 Months	Aspartate Aminotransferase (AST)
Laboratory Value: Alanine Aminotransferase (ALT)	Through study completion, up to 60 Months	Alanine Aminotransferase (ALT)
Laboratory Value: Gamma-glutamyl Transferase (GGT)	Through study completion, up to 60 Months	Gamma-glutamyl Transferase (GGT)
Laboratory Value: Bilirubin - Total Bilirubin	Through study completion, up to 60 Months	Bilirubin - Total Bilirubin
Laboratory Value: Bilirubin - Conjugated Bilirubin	Through study completion, up to 60 Months	Bilirubin - Conjugated Bilirubin
Laboratory Value: Bilirubin - Unconjugated Bilirubin	Through study completion, up to 60 Months	Bilirubin - Unconjugated Bilirubin

Countries

Argentina, Australia, Austria, Belgium, Canada, Chile, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Romania, Russia, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States

Contacts

STUDY_DIRECTORGilead Study Director

Gilead Sciences

Outcome results

None listed