Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)

Completed · Phase 2

Conditions studied: Primary Biliary Cirrhosis

In brief

An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)

Key facts

Study ID

NCT02955602

Run by

Gilead Sciences

People needed

119

Starts

2016-11-28

Expected to finish

2019-07-08

Last updated by the study team

2022-07-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have given written informed consent (signed and dated) and any authorizations required by local law
• 18 to 75 years old (inclusive)
• Male or female with a diagnosis of PBC, by at least two of the following criteria:
• History of AP above ULN for at least six months
• Positive AMA titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies
• Documented liver biopsy result consistent with PBC
• On a stable and recommended dose of UDCA for the past twelve months or intolerant to UDCA
• AP ≥ 1.67 × ULN
• 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 subjects 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

You may not qualify if…

• A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer on active treatment)
• AST or ALT > 3 × ULN
• Total bilirubin > 2.0 mg/dL
• Total bilirubin > ULN AND albumin < LLN with the exception to subjects with Gilbert's Syndrome. Subjects with Gilbert's syndrome are excluded if Direct Bilirubin > ULN.
• Auto-immune hepatitis
• Primary sclerosing cholangitis
• Known history of alpha-1-Antitrypsin deficiency
• Known history of chronic viral hepatitis
• Creatine kinase above ULN
• Serum creatinine above ULN
• For females, pregnancy or breast-feeding
• Use of colchicine, methotrexate, azathioprine, or systemic steroids in the two months preceding screening
• Current use of fibrates or simvastatin
• Current use of obeticholic acid
• Use of an experimental or unapproved treatment for PBC
• Use of experimental or unapproved immunosuppressant
• Adverse event leading to MBX-8025 discontinuation from CymaBay's phase 2 PBC study (CB8025-21528)
• Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator

Where it is running

• Institute for Liver Health — Chandler, Arizona, United States
• Southern California Research Center — Coronado, California, United States
• Standford University Medicine — Palo Alto, California, United States
• University of California, Davis Medical Center — Sacramento, California, United States
• Ventura Clinical Trials — Ventura, California, United States
• Florida Research Institute — Lakewood Rch, Florida, United States
• University of Miami - Center for Liver Diseases — Miami, Florida, United States
• Atlanta Gastroenterology Associates, LLC — Atlanta, Georgia, United States
• Digestive Healthcare of Georgia — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• Henry Ford Health System — Novi, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Saint Louis University, Gastroenterology & Hepatology — St Louis, Missouri, United States
• Northwell Health - Center for Liver Disease and Transplantation — Manhasset, New York, United States
• NYU Langone Medical Center — New York, New York, United States
• The Mount Sinai Medical Center — New York, New York, United States
• Northest Clinical Research Center, LLC. — Bethlehem, Pennsylvania, United States
• UT Southwestern Medical Center Investigation Drug Service — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Gastroenterology Consultants of SA — Live Oak, Texas, United States
• Bon Secours St. Mary's Immaculate Hospital — Newport News, Virginia, United States
• University of Washington — Seattle, Washington, United States
• University of Calgary Liver Unit — Calgary, Alberta, Canada
• Toronto Centre for Liver Disease — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.