Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC)
NCT ID: NCT02609048
Last Updated: 2025-02-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
41 participants
INTERVENTIONAL
2015-11-04
2016-07-01
Brief Summary
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Detailed Description
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To evaluate the effect of MBX-8025 on Alkaline Phosphatase (AP) levels
Secondary:
To evaluate the safety and tolerability of MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) To evaluate the effects of MBX-8025 on Primary Biliary Cirrhosis (PBC) response criteria To evaluate the effects of MBX-8025 on other markers of liver function, lipids, pruritus and Quality of Life (QoL)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo Dose
Participants received 2 placebo-to-match (PTM) seladelpar capsules, orally, once daily for 12 weeks.
Placebo Comparator
Placebo Capsule
Seladelpar 50 mg Dose
Participants received seladelpar 50 mg capsule (1 x 50 mg capsule) and a PTM seladelpar capsule, orally, once daily for 12 weeks.
Placebo Comparator
Placebo Capsule
Experimental: Seladelpar 50 mg
Seladelpar 50 mg capsule
Seladelpar 200 mg Dose
Participants received seladelpar 200 mg capsules (2 x 100 mg capsules), orally, once daily for 12 weeks.
Experimental: Seladelpar / MBX-8025 200 mg
Seladelpar 100 mg capsules
Interventions
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Placebo Comparator
Placebo Capsule
Experimental: Seladelpar 50 mg
Seladelpar 50 mg capsule
Experimental: Seladelpar / MBX-8025 200 mg
Seladelpar 100 mg capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 18 to 75 years old (inclusive)
3. Male or female with a diagnosis of PBC, by at least two of the following criteria:
* History of AP above upper limit of normal (ULN) for at least six months
* Positive Anti-Mitochondrial Antibodies (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
4. On a stable and recommended dose of UDCA for the past twelve months
5. AP ≥ 1.67 × ULN
6. For females of reproductive potential, use of at least one barrier contraceptive and a second effective birth control method during the study and for at least two weeks after the last dose. For male subjects, use of appropriate contraception (e.g., condoms), so their female partners of reproductive potential do not become pregnant during the study and for at least two weeks after the last dose
Exclusion Criteria
2. Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \> 3 × ULN
3. Total bilirubin \> 2 × ULN
4. Auto-immune hepatitis
5. Primary sclerosing cholangitis
6. Known history of alpha-1-Antitrypsin deficiency
7. Known history of chronic viral hepatitis
8. Creatine kinase above ULN
9. Serum creatinine above ULN
10. For females, pregnancy or breast-feeding
11. Use of colchicine, methotrexate, azathioprine, or systemic steroids in the two months preceding screening
12. Current use of fibrates, including fenofibrates, or simvastatin
13. Use of an experimental treatment for PBC
14. Use of experimental or unapproved immunosuppressant
15. 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
18 Years
75 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Pol F Boudes, M.D.
Role: STUDY_CHAIR
Gilead Sciences
Locations
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Mayo Clinic of Arizona
Phoenix, Arizona, United States
University of California, Davis Medical Center
Sacramento, California, United States
University of Florida
Gainesville, Florida, United States
University of Miami, Center for Liver Diseases
Miami, Florida, United States
Norman Gitlin, MD
Atlanta, Georgia, United States
Digestive Helathcare of Georgia
Atlanta, Georgia, United States
Indiana University Hospital - Clinical Research Center
Indianapolis, Indiana, United States
Henry Ford Health System
Detroit, Michigan, United States
Gastroenterology Associates of Western Michigan, PLC, d.b.a. West Michigan Clinical Research
Wyoming, Michigan, United States
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, United States
St. Louis University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center / The Nebraska Medical Center
Omaha, Nebraska, United States
North Shore-Long Island Jewish Health System / Division of Gastroenterology
Manhasset, New York, United States
NYU Langone Medical Center
New York, New York, United States
Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center
New York, New York, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
CHI St. Luke's Health Baylor College of Medicine Medical Center - Advanced Liver Therapies
Houston, Texas, United States
Pinnacle Clinical Research
Live Oak, Texas, United States
American Research Corporation at Texas Liver Institute
San Antonio, Texas, United States
Bon Secours St. Mary's Hospital of Richmond
Newport News, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
University of Calgary Liver Unit (Heritage Medical Research Clinic)
Calgary, Alberta, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Charite Universitatsmedizin Berlin - Campus Mitte
Berlin, , Germany
Leber- und Studienzentrum am Checkpoint
Berlin, , Germany
Universitatsklinikum Bonn
Bonn, , Germany
Universitatsklinikum Carl Gustav Carus an der TU Dresden
Dresden, , Germany
University Hospital Erlangen
Erlangen, , Germany
Universitatsklinikum Essen, Zentrum fur Innere Medizin
Essen, , Germany
Ifi-Studien und Projekte GmbH, A.d. Asklepios Klinik St. Georg
Hamburg, , Germany
Universitatsklinikum Hamburg-Eppendorf MARTINISTRASSE 52
Hamburg, , Germany
Med. Hochschule Hannover, Klinik fur Gastroenterologie
Hanover, , Germany
Medizinische Universitatsklinik
Heidelberg, , Germany
Gastroenterologische Gemeinschaftspraxis Herne
Herne, , Germany
UKSH, Campus Kiel, Klinik fur Allgemeine Innere Medizin 1
Kiel, , Germany
UKSH, Campus Kiel
Kiel, , Germany
Universitatsklinikum Leipzig AOR
Leipzig, , Germany
Universitatsmedizin der Johannes Gutenberg - Universitat Mainz
Mainz, , Germany
Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
SPZOZ Szpital Uniwersytecki w Krakowie
Krakow, Malopolski, Poland
Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
Warsaw, Masovian Voivodeship, Poland
SP CSK im. Prof. K. Gibinskiego SUM w Katowicach
Katowice, Silesian Voivodeship, Poland
ID Clinic Arkadiusz Pisula
Mysłowice, Silesian Voivodeship, Poland
Derriford Hospital
Plymouth, England, United Kingdom
University Hospital Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Addenbrooke Hospital
Cambridge, , United Kingdom
Hull and East Yorkshire NHS Trust
Hull, , United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Countries
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References
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Jones D, Boudes PF, Swain MG, Bowlus CL, Galambos MR, Bacon BR, Doerffel Y, Gitlin N, Gordon SC, Odin JA, Sheridan D, Worns MA, Clark V, Corless L, Hartmann H, Jonas ME, Kremer AE, Mells GF, Buggisch P, Freilich BL, Levy C, Vierling JM, Bernstein DE, Hartleb M, Janczewska E, Rochling F, Shah H, Shiffman ML, Smith JH, Choi YJ, Steinberg A, Varga M, Chera H, Martin R, McWherter CA, Hirschfield GM. Seladelpar (MBX-8025), a selective PPAR-delta agonist, in patients with primary biliary cholangitis with an inadequate response to ursodeoxycholic acid: a double-blind, randomised, placebo-controlled, phase 2, proof-of-concept study. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):716-726. doi: 10.1016/S2468-1253(17)30246-7. Epub 2017 Aug 14.
Other Identifiers
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2015-002698-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CB8025-21528
Identifier Type: -
Identifier Source: org_study_id
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