Last updated on June 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

Christopher Bowlus, MD

University of California, Davis Medical Center
Sacramento, CA United States

Cynthia Levy, MD

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

Norman Gitlin, MD

Atlanta Gastroenterology Associates, LLC
Atlanta, GA United States

Michael R Galambos, MD

Digestive Healthcare of Georgia
Atlanta, GA United States

Paul Thuluvath, MD

Mercy Medical Center
Baltimore, MD United States

Stuart C Gordon, MD

Henry Ford Health System
Novi, MI United States

Brian Borg, MD

University of Mississippi Medical Center
Jackson, MS United States

Bruce Bacon, MD

Saint Louis University, Gastroenterology & Hepatology
Saint Louis, MO United States

David Bernstein, MD

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

Carmen Stancia, MD

NYU Langone Medical Center
New York, NY United States

Joseph Odin, MD

The Mount Sinai Medical Center
New York, NY United States

Marlyn Mayo, MD

UT Southwestern Medical Center Investigation Drug Service
Dallas, TX United States

John M Vierling, MD

Baylor College of Medicine
Houston, TX United States

Stephen A Harrison, MD

Gastroenterology Consultants of SA
Live Oak, TX United States

Mitchell Shiffman, MD

Bon Secours St. Mary's Immaculate Hospital
Newport News, VA United States

Mark Swain, M.D.

University of Calgary Liver Unit
Calgary, AB Canada

Hemant Shah

Toronto Centre for Liver Disease
Toronto, ON Canada

Yvonne Dorffel, MD

Outpatient Clinic of Internal Medicine
Berlin, Germany

Andreas Kremer, MD

University Hospital Erlangen
Erlangen, Germany

Peter Buggisch, MD

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

Michael Manns, MD

Center of Internal Medicine - Medical School of Hannover
Hannover, Germany

Marcus Worns, MD

University Medical Centre of the Johannes Guttenberg-University
Mainz, Germany

Christoph Berg, MD

Medizinische Universitatsklinik Tubingen
Tubingen, Germany

Gideon Hirschfield, MD

University Hospitals Birmingham
Birmingham, United Kingdom

George Mells, MD

Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom

Lynsey Corless, MD

Hull and East Yorkshire Hospitals NHS Trust
Hull, United Kingdom

Douglas Thorburn, MD

Royal Free London NHS Foundation Trust
London, United Kingdom

David Sheridan, MD

Plymouth Hospitals NHS Trust
Plymouth, United Kingdom

Richard Aspinall, MD

Portsmouth Hospitals NHS Trust
Portsmouth, United Kingdom

Sabine Hazan, MD

Ventura Clinical Trials
Ventura, CA United States

Steven Flamm, MD

Northwestern University
Chicago, IL United States

Charles Landis, MD

University of Washington
Seattle, WA United States

Till Wissniowski, MD

Universitatsklinikum Giessen und Marburg GmbH
Marburg, Germany

Aparna Goel, MD

Standford University Medicine
Palo Alto, CA United States

Aparna Goel, MD

Stanford University
Stanford, CA United States

Anita Kohli, MD

Institute for Liver Health
Chandler, AZ United States

Adam Peyton, MD

Northest Clinical Research Center, LLC.
Bethlehem, PA United States

Guy Neff, MD

Florida Research Institute
Lakewood Ranch, FL United States