Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)
NCT ID: NCT03301506
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2017-12-12
2028-11-30
Brief Summary
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Detailed Description
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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)
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Seladelpar 5 mg Capsules
Seladelpar 5 mg Capsule
Participants will be assigned to a treatment group if tolerability issues noted in the previous study.
Seladelpar 10 mg Capsule
Seladelpar 10 mg Capsule
Participants will be assigned to a treatment group unless there are tolerability issues.
Interventions
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Seladelpar 5 mg Capsule
Participants will be assigned to a treatment group if tolerability issues noted in the previous study.
Seladelpar 10 mg Capsule
Participants will be assigned to a treatment group unless there are tolerability issues.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
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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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Arkansas Diagnostic Center
Little Rock, Arkansas, United States
Stanford University School of Medicine
Palo Alto, California, United States
California Liver Research Institute
Pasadena, California, United States
University of California Davis Medical Center
Sacramento, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of Colorado - Denver - PPDS
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Covenant Research Fort Myers
Fort Myers, Florida, United States
Florida Digestive Health Specialist
Lakewood Rch, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Covenant Research, LLC
Sarasota, Florida, United States
Digestive Healthcare of Georgia PC
Atlanta, Georgia, United States
University of Chicago Hospitals
Chicago, Illinois, United States
East Jefferson General Hospital
New Orleans, Louisiana, United States
Mercy Medical Center (Baltimore)
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center - 330 Brookline Ave
Boston, Massachusetts, United States
Henry Ford Health System
Novi, Michigan, United States
MNGI Digestive Health PA-Plymouth
Minneapolis, Minnesota, United States
Southern Therapy and Advanced Research LLC
Jackson, Mississippi, United States
Saint Louis University
St Louis, Missouri, United States
NYU Langone Medical Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of Rochester Medical Center - PPDS
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Galen Medical Group
Chattanooga, Tennessee, United States
Gastro One-8110 Walnut Run Rd
Cordova, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Liver Institute at Methodist Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
The Texas Liver Institute - 607 Camden St
San Antonio, Texas, United States
Pinnacle Clinical Research, PLLC
San Antonio, Texas, United States
Maryview Hospital Inc., d/b/a Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, United States
Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond
Richmond, Virginia, United States
Liver Institute Northwest, PLLC
Seattle, Washington, United States
CINME S.A. - Centro de Investigaciones Metabólicas-Viamonte 2278
Balvanera, , Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
DIM Clínica Privada
El Palomar, , Argentina
Hospital Italiano de La Plata
La Plata, , Argentina
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Klinikum Wels-Grieskirchen GmbH - Standort Wels
Wels, , Austria
UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
University of Calgary Medicine
Calgary, , Canada
Toronto General Hospital
Toronto, , Canada
Centro Clinico Mediterraneo
La Serena, , Chile
Fakultni nemocnice Ostrava
Ostrava, , Czechia
Hospices Civils de Lyon - Hôpital de La Croix Rousse
Lyon, , France
AP-HP - Hôpital Saint Antoine
Paris, , France
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universitatsklinkum Erlangen-Ulmenweg 18
Erlangen, , Germany
ifi-Institute for Interdisciplinary Medicine
Hamburg, , Germany
Gastroenterologische Gemeinschaftspraxis Herne
Herne, , Germany
Gastroenterologisch Hepatologisches Zentrum Kiel - Preetzer Chaussee 134
Kiel, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
University General Hospital of Larissa
Larissa, , Greece
Semmelweis Egyetem
Budapest, , Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, , Hungary
Carmel Medical Center
Haifa, , Israel
Hadassah Medical Center- Ein Kerem - PPDS
Jerusalem, , Israel
The Chaim Sheba Medical Center - PPDS
Tel Aviv, , Israel
Tel Aviv Sourasky Medical Center Ichilov - PPDS
Tel Aviv, , Israel
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
Modena, , Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone-Palermo-Piazza Delle Cliniche 2
Palermo, , Italy
Fondazione IRCCS San Gerardo dei Tintori
Rozzano, , Italy
Consultorio de la Doctora Maria Sarai Gonzalez Huezo
Metepec, , Mexico
Consultorio Medico - Distrito Federal
Roma Norte, , Mexico
Radboud Universitair Medisch Centrum
Nijmegen, , Netherlands
Christchurch Hospital
Christchurch, , New Zealand
Dunedin Hospital
Dunedin, , New Zealand
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowi
Katowice, , Poland
ID Clinic Arkadiusz Pisula
Mysłowice, , Poland
Fundeni Clinical Institute
Bucharest, , Romania
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, , South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Songpa-Gu, , South Korea
Hospital Universitario Germans Trias i Pujol
Badalona, , Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario La Paz - PPDS
Horcajo de la Sierra, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Universitätsspital Zürich
Zurich, , Switzerland
Gazi University Faculty of Medicine
Ankara, , Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi
Bornova, , Turkey (Türkiye)
Ankara Bilkent City Hospital
Çankaya, , Turkey (Türkiye)
Marmara University Pendik Training and Research Hospital
Maltepe, , Turkey (Türkiye)
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Topkapı, , Turkey (Türkiye)
Queen Elizabeth Hospital Birmingham
Birmingham, , United Kingdom
Hull Royal Infirmary
Hull, , United Kingdom
Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre
London, , United Kingdom
King's College Hospital
London, , United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Queen's Medical Centre
Nottingham, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Queen Alexandra Hospital
Portsmouth, , United Kingdom
Countries
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References
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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.
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2020-005198-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-511753-22-00
Identifier Type: CTIS
Identifier Source: secondary_id
CB8025-31731-RE
Identifier Type: -
Identifier Source: org_study_id