Last updated on March 2018

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


Brief description of study

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)

Detailed Study Description

Primary

To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 8 weeks of treatment

Secondary

To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 12 and 26 weeks of treatment

To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 52 weeks of treatment

To evaluate the pharmacokinetics (PK) of MBX-8025

Exploratory

To evaluate the effect of MBX-8025 on bile acids, additional markers of inflammation and renal function

MBX-8025 doses of 1 mg and 15 mg may be evaluated if dose adjustment occurs

Clinical Study Identifier: NCT02955602

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Tarek Hassanein, MD

Southern California Research Center
Coronado, CA United States
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Christopher Bowlus, MD

University of California, Davis Medical Center
Sacramento, CA United States
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Cynthia Levy, MD

University of Miami - Center for Liver Diseases
Miami, FL United States
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Norman Gitlin, MD

Atlanta Gastroenterology Associates, LLC
Atlanta, GA United States
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Michael R Galambos, MD

Digestive Healthcare of Georgia
Atlanta, GA United States
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Paul Thuluvath, MD

Mercy Medical Center
Baltimore, MD United States
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Stuart C Gordon, MD

Henry Ford Health System
Novi, MI United States
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Brian Borg, MD

University of Mississippi Medical Center
Jackson, MS United States
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Bruce Bacon, MD

Saint Louis University, Gastroenterology & Hepatology
Saint Louis, MO United States
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David Bernstein, MD

Northwell Health - Center for Liver Disease and Transplantation
Manhasset, NY United States
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Carmen Stancia, MD

NYU Langone Medical Center
New York, NY United States
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Joseph Odin, MD

The Mount Sinai Medical Center
New York, NY United States
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Marlyn Mayo, MD

UT Southwestern Medical Center Investigation Drug Service
Dallas, TX United States
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John M Vierling, MD

Baylor College of Medicine
Houston, TX United States
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Stephen A Harrison, MD

Gastroenterology Consultants of SA
Live Oak, TX United States
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Mitchell Shiffman, MD

Bon Secours St. Mary's Immaculate Hospital
Newport News, VA United States
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Mark Swain, M.D.

University of Calgary Liver Unit
Calgary, AB Canada
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Hemant Shah, MD

Toronto Centre for Liver Disease
Toronto, ON Canada
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Yvonne Dorffel, MD

Outpatient Clinic of Internal Medicine
Berlin, Germany
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Andreas Kremer, MD

University Hospital Erlangen
Erlangen, Germany
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Peter Buggisch, MD

Ifi-Studien und Projekte GmbH, An der Asklepios Klinik St. Georg
Hamburg, Germany
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Michael Manns, MD

Center of Internal Medicine - Medical School of Hannover
Hannover, Germany
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Marcus Worns, MD

University Medical Centre of the Johannes Guttenberg-University
Mainz, Germany
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Christoph Berg, MD

Medizinische Universitatsklinik Tubingen
Tubingen, Germany
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Gideon Hirschfield, MD

University Hospitals Birmingham
Birmingham, United Kingdom
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George Mells, MD

Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
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Lynsey Corless, MD

Hull and East Yorkshire Hospitals NHS Trust
Hull, United Kingdom
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Douglas Thorburn, MD

Royal Free London NHS Foundation Trust
London, United Kingdom
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David Sheridan, MD

Plymouth Hospitals NHS Trust
Plymouth, United Kingdom
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Richard Aspinall, MD

Portsmouth Hospitals NHS Trust
Portsmouth, United Kingdom
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Sabine Hazan, MD

Ventura Clinical Trials
Ventura, CA United States
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Steven Flamm, MD

Northwestern University
Chicago, IL United States
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Charles Landis, MD

University of Washington
Seattle, WA United States
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Till Wissniowski, MD

Universitatsklinikum Giessen und Marburg GmbH
Marburg, Germany
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Aparna Goel, MD

Standford University Medicine
Palo Alto, CA United States
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Aparna Goel, MD

Stanford University
Stanford, CA United States
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