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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Primary Biliary Cirrhosis
• Intervention / Treatment: Drug: Seladelpar 5 mg Capsule; Drug: Seladelpar 10 mg Capsule

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)

• Study Type: Interventional
• Enrollment (Estimated): 340
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Balvanera, Argentina, C1056ABJ
    • CINME S.A. - Centro de Investigaciones Metabólicas-Viamonte 2278
  • Buenos Aires, Argentina, 1181
    • Hospital Italiano de Buenos Aires
  • El Palomar, Argentina, 1684
    • Dim Clinica Privada
  • La Plata, Argentina, B1902AWL
    • Hospital Italiano de La Plata
• Australia
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital
• Austria
  • Wels, Austria, 4710
    • Klinikum Wels-Grieskirchen GmbH - Standort Wels
• Belgium
  • Ghent, Belgium, 9000
    • UZ Gent
  • Leuven, Belgium, 3000
    • UZ Leuven
• Canada
  • Calgary, Canada, T2N 4Z6
    • University of Calgary Medicine
  • Toronto, Canada, M5G 2C4
    • Toronto General Hospital
• Chile
  • La Serena, Chile, 1720506
    • Centro Clinico Mediterraneo
• Czechia
  • Ostrava, Czechia, 708 00
    • Fakultni nemocnice Ostrava
• France
  • Lyon, France, 69004
    • Hospices Civils de Lyon - Hôpital de la Croix Rousse
  • Paris, France, 75012
    • AP-HP - Hôpital Saint Antoine
• Germany
  • Berlin, Germany, 10117
    • Charite - Universitatsmedizin Berlin
  • Erlangen, Germany, 91054
    • Universitatsklinkum Erlangen-Ulmenweg 18
  • Hamburg, Germany, 20099
    • ifi-Institute for Interdisciplinary Medicine
  • Herne, Germany, 44623
    • Gastroenterologische Gemeinschaftspraxis Herne
  • Kiel, Germany, 24146
    • Gastroenterologisch Hepatologisches Zentrum Kiel - Preetzer Chaussee 134
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
• Greece
  • Larissa, Greece, 411 10
    • University General Hospital of Larissa
• Hungary
  • Budapest, Hungary, 1082
    • Semmelweis Egyetem
  • Kaposvár, Hungary, 7400
    • Somogy Varmegyei Kaposi Mor Oktato Korhaz
• Israel
  • Haifa, Israel, 34462
    • Carmel Medical Center
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center- Ein Kerem - PPDS
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Center Ichilov - PPDS
  • Tel Aviv, Israel, 5262100
    • The Chaim Sheba Medical Center - PPDS
• Italy
  • Modena, Italy, 41126
    • Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
  • Palermo, Italy, 90127
    • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone-Palermo-Piazza Delle Cliniche 2
  • Rozzano, Italy, 20089
    • Fondazione IRCCS San Gerardo dei Tintori
• Mexico
  • Metepec, Mexico, 52120
    • Consultorio de la Doctora Maria Sarai Gonzalez Huezo
  • Roma Norte, Mexico, 06700
    • Consultorio Medico - Distrito Federal
• Netherlands
  • Nijmegen, Netherlands, 6525 GA
    • Radboud Universitair Medisch Centrum
• New Zealand
  • Christchurch, New Zealand, 4710
    • Christchurch Hospital
  • Dunedin, New Zealand, 9012
    • Dunedin Hospital
• Poland
  • Katowice, Poland, 40-752
    • Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowi
  • Mysłowice, Poland, 41-400
    • ID Clinic Arkadiusz Pisula
• Romania
  • Bucharest, Romania, 22328
    • Fundeni Clinical Institute
• Russia
  • Saint Petersburg, Russia, 197110
    • SPbGU Medical and diagnostic center of the clinic of high medical technology n.a. N.I. Pirogov
• South Korea
  • Bucheon-si, South Korea, 14584
    • Soon Chun Hyang University Hospital Bucheon
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Busan, South Korea, 47392
    • Inje University Busan Paik Hospital
  • Daegu, South Korea, 41944
    • Kyungpook National University Hospital
  • Seongnam, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Songpa-Gu, South Korea, 05505
    • Asan Medical Center
• Spain
  • Badalona, Spain, 08916
    • Hospital Universitario Germans Trias i Pujol
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron - PPDS
  • Barcelona, Spain, 8036
    • Hospital Clinic De Barcelona
  • Horcajo de la Sierra, Spain, 28755
    • Hospital Universitario La Paz - PPDS
  • Madrid, Spain, 28026
    • Hospital Universitario 12 de Octubre
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria
  • Santander, Spain, 39008
    • Hospital Universitario Marqués de Valdecilla
• Switzerland
  • Zurich, Switzerland, 8091
    • UniversitätsSpital Zürich
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 6590
    • Gazi University Faculty of Medicine
  • Bornova, Turkey (Türkiye), 35100
    • Ege Universitesi Tip Fakultesi Hastanesi
  • Maltepe, Turkey (Türkiye), 34840
    • Marmara University Pendik Training and Research Hospital
  • Topkapı, Turkey (Türkiye), 34093
    • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
  • Çankaya, Turkey (Türkiye), 06800
    • Ankara Bilkent City Hospital
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Queen Elizabeth Hospital Birmingham
  • Hull, United Kingdom, HU3 2JZ
    • Hull Royal Infirmary
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
  • London, United Kingdom, E1 1BB
    • Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre
  • Newcastle upon Tyne, United Kingdom, NE4 6BE
    • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
  • Nottingham, United Kingdom, NG7 2UH
    • Queen's Medical Centre
  • Plymouth, United Kingdom, PL6 8DH
    • Derriford Hospital
  • Portsmouth, United Kingdom, PO6 3LY
    • Queen Alexandra Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Diagnostic Center
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University School of Medicine
    • Pasadena, California, United States, 91105
      • California Liver Research Institute
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
    • San Francisco, California, United States, 94115
      • California Pacific Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado - Denver - PPDS
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine
  • Florida
    • Fort Myers, Florida, United States, 33606
      • Covenant Research Fort Myers
    • Lakewood Rch, Florida, United States, 34211
      • Florida Digestive Health Specialist
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine
    • Sarasota, Florida, United States, 33912
      • Covenant Research, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Digestive Healthcare of Georgia PC
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Hospitals
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • East Jefferson General Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center (Baltimore)
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center - 330 Brookline Ave
  • Michigan
    • Novi, Michigan, United States, 48377
      • Henry Ford Health System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55413
      • MNGI Digestive Health PA-Plymouth
  • Mississippi
    • Jackson, Mississippi, United States, 39157
      • Southern Therapy and Advanced Research LLC
  • Missouri
    • St Louis, Missouri, United States, 63104
      • Saint Louis University
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10021
      • Weill Cornell Medical College
    • New York, New York, United States, 10021
      • NYU Langone Medical Center
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center - PPDS
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Northeast Clinical Research Center, LLC
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Health Milton S. Hershey Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Galen Medical Group
    • Cordova, Tennessee, United States, 38018
      • Gastro One-8110 Walnut Run Rd
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75203
      • Liver Institute at Methodist Dallas
    • Dallas, Texas, United States, 39090
      • University of Texas Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • San Antonio, Texas, United States, 78229
      • Pinnacle Clinical Research, PLLC
    • San Antonio, Texas, United States, 78215 1619
      • The Texas Liver Institute - 607 Camden St
  • Virginia
    • Newport News, Virginia, United States, 23602
      • Maryview Hospital Inc., d/b/a Bon Secours Liver Institute of Hampton Roads
    • Richmond, Virginia, United States, 23226
      • Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond
  • Washington
    • Seattle, Washington, United States, 98195
      • Liver Institute Northwest, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

Exclusion criteria are only applicable for individuals with a seladelpar interruption greater than 4 weeks prior to Day 1 of this study and for individuals who participated in CB8025-21838 irrespective of seladelpar interruption.

1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results (eg, cancer, any active infection)
3. AST or ALT above 3 × the upper limit of normal (ULN)
4. Total bilirubin above 2 × ULN
5. MELD score ≥ 12. For individuals on anticoagulation medication, evaluation of the baseline INR, in concert with any current dose adjustments in anti-coagulant medications, will be taken into account when calculating this score. This will be done in consultation with the medical monitor.
6. Evidence of advanced PBC as defined by the Rotterdam criteria: albumin below 1× the lower limit of normal (LLN) AND total bilirubin above 1 × ULN)
7. eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula)
8. Auto-immune hepatitis
9. Primary sclerosing cholangitis
10. Known history of alpha-1-antitrypsin deficiency
11. Known history of chronic viral hepatitis
12. For females, pregnancy or breast-feeding
13. Use of colchicine, methotrexate, azathioprine, or long-term use of systemic steroids (eg prednisone, prednisolone, budesonide) (>2 weeks) within 2 months prior to Screening
14. Current use of fibrates or use of fibrates within 3 months prior to Screening
15. Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening
16. Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening
17. History of malignancy diagnosed or treated, actively or within 2 years, or active evaluation for malignancy; localized treatment of squamous or non-invasive basal cell skin cancers and cervical carcinoma in-situ is allowed if appropriately treated prior to Screening
18. Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening
19. Any other condition(s) that would compromise the safety of the individual or compromise the quality of the clinical study, as judged by the Investigator
20. Immunosuppressant therapies (eg, cyclosporine, tacrolimus, anti-TNF or other immunosuppressive biologics)
21. Other medications that effect liver or GI functions such as absorption of medications or the roux-en-y gastric bypass procedure may be prohibited and should be discussed with the medical monitor on a case-by-case basis

22. Positive for:

    1. Hepatitis B, defined as the presence of hepatitis B surface antigen
    2. Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid (RNA)
    3. Human immunodeficiency virus (HIV) antibody
23. Active COVID-19 infection during screening

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Seladelpar 5 mg Capsules	Drug: Seladelpar 5 mg Capsule; Participants will be assigned to a treatment group if tolerability issues noted in the previous study.; Other Names: MBX-8025; Livdelzi®
Experimental: Seladelpar 10 mg Capsule	Drug: Seladelpar 10 mg Capsule; Participants will be assigned to a treatment group unless there are tolerability issues.; Other Names: MBX-8025; Livdelzi®

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

General Publications

• Levy C, Trivedi PJ, Kowdley KV, Gordon SC, Bowlus CL, Londono MC, Hirschfield GM, Gulamhusein A, Lawitz EJ, Vierling JM, Mayo MJ, Jacobson IM, Kremer AE, Corpechot C, Jones D, Buggisch P, Zhuo S, Proehl S, Heusner C, McWherter CA, Crittenden DB; ASSURE Investigators. Long-Term Efficacy and Safety of Selective PPARdelta Agonist Seladelpar in Primary Biliary Cholangitis: ASSURE Interim Study Results. Am J Gastroenterol. 2025 Jun 24. doi: 10.14309/ajg.0000000000003603. Online ahead of print.
• Mayo MJ, Vierling JM, Bowlus CL, Levy C, Hirschfield GM, Neff GW, Galambos MR, Gordon SC, Borg BB, Harrison SA, Thuluvath PJ, Goel A, Shiffman ML, Swain MG, Jones DEJ, Trivedi P, Kremer AE, Aspinall RJ, Sheridan DA, Dorffel Y, Yang K, Choi YJ, McWherter CA. Open-label, clinical trial extension: Two-year safety and efficacy results of seladelpar in patients with primary biliary cholangitis. Aliment Pharmacol Ther. 2024 Jan;59(2):186-200. doi: 10.1111/apt.17755. Epub 2023 Oct 30.

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2017
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: September 29, 2017
• First Posted (Actual): October 4, 2017

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: PBC; Primary Biliary Cholangitis (PBC)
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Biliary Tract Diseases; Liver Diseases; Bile Duct Diseases; Fibrosis; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Pathological Conditions, Signs and Symptoms; Liver Cirrhosis, Biliary; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; seladelpar; (2-methyl-4-(5-methyl-2-(4-trifluoromethyl-phenyl)-2H-(1,2,3)triazol-4-ylmethylsulfanyl)phenoxy)acetic acid
• Other Study ID Numbers: CB8025-31731-RE; 2020-005198-29 (EudraCT Number); 2024-511753-22-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No