A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
NCT ID: NCT05050136
Last Updated: 2026-01-20
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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RECRUITING
PHASE2
260 participants
INTERVENTIONAL
2021-09-22
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part 1 Arm 1: Volixibat 20mg
Participants randomized to this arm will receive volixibat 20mg twice daily.
Volixibat
Oral capsules, administered twice daily. Volixibat is an Ileal Bile Acid Transporter (IBAT) inhibitor.
Part 1 Arm 2: Volixibat 80mg
Participants randomized to this arm will receive volixibat 80mg twice daily.
Volixibat
Oral capsules, administered twice daily. Volixibat is an Ileal Bile Acid Transporter (IBAT) inhibitor.
Part 1 Arm 3: Placebo
Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily.
Placebo
Capsules matched to study drug without the active pharmaceutical ingredient
Part 2 Arm 1: Volixibat Selected Dose 20mg
Participants randomized to this arm will receive volixibat 20mg twice daily.
Volixibat
Oral capsules, administered twice daily. Volixibat is an Ileal Bile Acid Transporter (IBAT) inhibitor.
Part 2 Arm 2: Placebo
Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily.
Placebo
Capsules matched to study drug without the active pharmaceutical ingredient
Interventions
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Placebo
Capsules matched to study drug without the active pharmaceutical ingredient
Volixibat
Oral capsules, administered twice daily. Volixibat is an Ileal Bile Acid Transporter (IBAT) inhibitor.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female, age ≥18 years at the screening visit
* Confirmed diagnosis of PBC in line with the AASLD guidelines
* UDCA, anti-pruritic medication and PPAR agonist use will be allowed if meeting additional criteria
* Qualified pruritus associated with PBC as assessed by Adult ItchRO
Exclusion Criteria
* Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events
* Current symptomatic cholelithiasis or inflammatory gallbladder disease
* History of small bowel surgery/resection impacting the terminal ileum that may disrupt the enterohepatic circulation.
* Evidence, history, or suspicion of other liver diseases; PBC patients with AIH are not excluded
* History of Liver transplantation
18 Years
ALL
No
Sponsors
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Mirum Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Southern California Research Center
Coronado, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
UC Davis
Sacramento, California, United States
University of Colorado
Aurora, Colorado, United States
Yale University Digestive Diseases
New Haven, Connecticut, United States
Covenant Metabolic Specialists
Fort Myers, Florida, United States
UF Hepatology Research at CTRB
Gainesville, Florida, United States
UF Health Gastroenterology- Emerson
Jacksonville, Florida, United States
IHS Health
Kissimmee, Florida, United States
Schiff Center for Liver Diseases
Miami, Florida, United States
Advanced Research Institute, Inc
New Port Richey, Florida, United States
Covenant Research and Clinics, LLC
Sarasota, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Southeast Clinical Research Center
Dalton, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Loyola University Health System - Loyola Outpatient Center
Maywood, Illinois, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Ochsner Clinic Foundation-Baton Rouge
Baton Rouge, Louisiana, United States
LSU Health Science Center Shreveport
Shreveport, Louisiana, United States
Beth Israel Deaconess
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Jackson Liver and GI Specialists
Jackson, Mississippi, United States
CHI Health Clinic (Alegent Creighton Clinic)- Gastroenterology-Bergan
Omaha, Nebraska, United States
Science 37, Inc (Remote-homebased Telemedicine)
Morrisville, North Carolina, United States
Cleveland Clinic - Main Campus
Cleveland, Ohio, United States
Einstein Healthcare Network - Einstein Medical Center
Philadelphia, Pennsylvania, United States
Methodist Le Bonheur Healthcare
Memphis, Tennessee, United States
Galen Medical Group, P.C
Tennessee City, Tennessee, United States
Amel Med LLC
Austin, Texas, United States
Soma Clinical Trials
Denison, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Liver Associates of Texas
Houston, Texas, United States
Velocity Clinical Research
Waco, Texas, United States
University of Utah Health Care
Salt Lake City, Utah, United States
MedStar Health Research Institute
Fairfax, Virginia, United States
Bon Secours Liver Institute of Hampton Roads Mary Immaculate Hospital
Newport News, Virginia, United States
Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond
Richmond, Virginia, United States
Liver Institute Northwest
Seattle, Washington, United States
Hospital de Alta Complejidad En Red El Cruce
San Juan Bautista, Buenos Aires, Argentina
Hospital Provincial Del Centenario
Rosario, Santa Fe Province, Argentina
Glenny Corp S.A
CABA, , Argentina
Universitair Ziekenhuis Antwerpe UZA
Antwerp, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
Centro de Pesquisa Clínica da Bahiana Saúde
Salvador, Estado de Bahia, Brazil
Hospital Das Clínicas Da Ufg
Goiânia, Goiás, Brazil
Centro de Pesquisas Clínicas do HC/UFMG-EBSERH
Belo Horizonte, Minas Gerais, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Oswaldo Ramos
São Paulo, , Brazil
Gordon and Leslie Diamond Health Care Centre, Division of Gastroenterology
Vancouver, British Columbia, Canada
(G.I.R.I.) GI Research Institute Foundation
Vancouver, British Columbia, Canada
McMaster University Medical Center
Hamilton, Ontario, Canada
University Hospital, LHSC
London, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
University of Alberta
Edmonton, , Canada
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Beijing Youan Hospital, Capital Medical University
Beijing, , China
Beijing Friendship Hospital, Capital Medical University
Beijing, , China
Sir Run Run Shaw Hospital -Zhejiang University School of Medicine
Hangzhou, , China
CHU Grenoble - Hôpital MICHALLON
Grenoble, , France
Hopital Claude Huriez-Digestive system disease clinic
Lille, , France
CHU de NICE- Hospital L'Archet 2
Nice, , France
Hospital Saint Antoine
Paris, , France
Nouvel Hospital Civil
Strasbourg, , France
Hospital Paul Brousse- APHP
Villejuif, , France
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Universitätsklinikum Frankfurt am Main
Frankfurt, , Germany
Medizinische Hochschule Hannover (MHH)
Hanover, , Germany
Universitätsklinikum Schleswig-Holstein
Kiel, , Germany
Universitätsklinikum Leipzig, Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie
Leipzig, , Germany
University Hospital Munster
Münster, , Germany
University Hospital Tübingen Medical clinic
Tübingen, , Germany
St. Josefs-Hospital Wiesbaden
Wiesbaden, , Germany
Hillel Yaffe Medical Center
Hadera, , Israel
Rambam Medical Center
Haifa, , Israel
Carmel Medical Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah Medical Center - Ein Karem, Liver Institute Kiryat Hadassah POB 12000
Jerusalem, , Israel
Galilee Medical Center
Nahariya, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Universita Politecnica delle Marche- Ospedali Riuniti
Ancona, , Italy
ASST Papa Giovanni XXIII
Bergamo, , Italy
Fondazione Ca Granda
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, , Italy
Azienda Ospedale-Università di Padova
Padua, , Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, , Italy
Azienda Ospedaliero Universitaria Pisana (AOUP)
Pisa, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
National Hospital Organization Nagasaki Medical Center
Ōmura, Nagasaki, Japan
Ehime University Hospital
Ehime, , Japan
Teine Keijinkai Hospital
Hokkaido, , Japan
Osaka Rosai Hospital
Osaka, , Japan
Toranomon Hospital
Tokyo, , Japan
Amstedam University Medical Centers
Amsterdam, , Netherlands
Radboudumc
Nijmegen, , Netherlands
Erasmus medical center
Rotterdam, , Netherlands
Hospital Universitari Vall d' Hebron
Barcelona, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital Universitari Parc Tauli
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Ente Ospedaliero Cantonale
Lugano, , Switzerland
University Hospital Zurich(USZ)
Zurich, , Switzerland
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom
Belfast Health & Social Care Trust (BHSCT) Royal Victoria Hospital
Belfast, , United Kingdom
Royal Free Hospital NHS Foundation Trust
London, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Countries
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Facility Contacts
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Sydney Boles
Role: backup
Role: backup
References
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Klatzkow H, Bhavsar-Burke I, Pearson M, Wentworth BJ. Primary Biliary Cholangitis in 2025: A New Frontier. Am J Gastroenterol. 2025 Dec 1;120(12):2746-2749. doi: 10.14309/ajg.0000000000003559. Epub 2025 May 29. No abstract available.
Other Identifiers
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VLX-601
Identifier Type: -
Identifier Source: org_study_id
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