A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

182

Participants

Timeline

Start Date

December 18, 2020

Primary Completion Date

June 30, 2026

Study Completion Date

April 30, 2027

Conditions
Primary Sclerosing Cholangitis
Interventions
DRUG

Volixibat

Oral capsules, administered twice daily. Volixibat is an Ileal Bile Acid Transporter (IBAT) inhibitor.

DRUG

Placebo

Capsules matched to study drug minus active substance

Trial Locations (103)

1200

Cliniques Universitaires Saint-Luc, Brussels

2170

Liverpool Hospital, Liverpool

3084

Austin Health, Melbourne

4556

University of the Sunshine Coast, Sippy Downs

5000

Royal Adelaide Hospital, Adelaide

8091

University Hospital Zurich, Zurich

9000

Universitair Ziekenhuis Antwerpen (UZA), Ghent

University Hospital Ghent, Ghent

10016

New York University Langone Health, New York

10021

Weill Cornell Medical College, New York

10032

Columbia University Medical Center - Presbyterian Hospital and Vanderbilt Clinic, New York

11030

Northwell Health, Manhasset

13353

Charité Universtitätsmedizin - Campus Virchow-Klinikum, Berlin

14642

University of Rochester Medical Center - Strong Memorial Hospital, Rochester

15213

University of Pittsburgh Medical Center, Pittsburgh

19141

Einstein Healthcare Network - Einstein Medical Center, Philadelphia

20007

MedStar Georgetown University Hospital, Washington D.C.

20122

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

20900

Fondazione IRCCS San Gerardo dei Tintori, Monza

23226

Richmond Community Hospital LLC, Richmond

23603

Bon Secours Liver Institution of Hampton Roads Mary Immaculate Hospital Office, Newport News

24105

Universitätsklinikum Schleswig-Holstein - Campus Kiel, Kiel

27560

Science 37, Inc (Remote-homebased Telemedicine), Morrisville

27710

Duke Health - Duke University Medical Center, Durham

28007

Hospital General Universitario Gregorio Maranon, Madrid

30625

Hannover Medical School, Hanover

33136

University of Miami - Schiff Center for Liver Diseases, Miami

33600

CHU Bordeaux - Haut Lévêque, Pessac

33606

Tampa General Hospital, Tampa

34211

Florida Research Institute, Lakewood Rch

35100

Azienda Ospedale Universita Padova, Padua

37232

Vanderbilt University Medical Center, Nashville

37343

Galen Medical Group, Hixson

38043

Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes), Grenoble

38100

Hillel Yaffe Medical Center, Hadera

39120

Otto-von-Guericke-Universitat Magdeburg, Magdeburg

39216

Southern Therapy and Advanced Research LLC, Jackson

40138

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S. Orsola-Malpighi, Bologna

44195

Cleveland Clinic, Cleveland

48202

Henry Ford Hospital, Detroit

52621

Sheba Medical Center, Ramat Gan

53127

Universitaetsklinikum Bonn, Bonn

55905

Mayo Clinic, Rochester

59037

Centre Hospitalier Universitaire de Lille, Lille

65189

St. Josefs-Hospital Wiesbaden, Wiesbaden

72076

University Hospital Tubingen Medical Clinic, Tübingen

75203

The Liver Institute At Methodist Dallas Medical Center, Dallas

75390

University of Texas Southwestern Medical Center, Dallas

75571

APHP-Hôpital Saint Antoine, Paris

77030

Houston Methodist Hospital, Houston

Liver Associates of Texas, Houston

80045

University of Colorado - Anschutz Medical Campus, Aurora

80131

A.O.U. Federico II, Napoli

84132

University of Utah Health Care, Salt Lake City

90048

Cedars Sinai Medical Center, Los Angeles

91054

Universitaetsklinikum Erlangen, Erlangen

91120

Hadassah Medical Center - Ein Karem, Jerusalem

92118

Southern California Research Center, Coronado

94109

California Pacific Medical Center Research Institute, San Francisco

95817

University of California, Davis, Sacramento

98104

University of Washington - Harborview Medical Center, Seattle

98105

Liver Institute Northwest, Seattle

2210001

Galilee Medical Center, Nahariya

3109601

Rambam Medical Center, Haifa

3434104

Carmel Medical Center, Haifa

4941492

Rabin Medical Center, Petah Tikva

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

9103102

Shaare Zedek Medical Center, Jerusalem

02215

Beth Israel Deaconess Medical Center, Boston

C1199

Hospital Italiano de Buenos Aires, Buenos Aires

C1430

Glenny Corp S.A., Ciudad Autónoma Buenos Aires

B1888

Hospital El Cruce, San Juan Bautista

VIC 3076

Northern Health, Epping

30140-080

Hospital das Clinicas da UFMG, Belo Horizonte

74535-170

Hospital Das Clínicas Da Ufg, Goiânia

90035-903

Hospital de Clinicas de Porto Alegre, Porto Alegre

40290-000

Escola Bahiana de Medicina e Saude Publica, Salvador

04038-002

Hospital do Rim e Hipertensao, São Paulo

T6G 2R3

University of Alberta, Edmonton

L8L 0A4

McMaster University Hospital, Hamilton

Unknown

The Ottawa Hospital - General Campus, Ottawa

University Hospital Southampton NHS Foundation Trust, Southampton

M5G 2C4

University Health Network - Toronto General Hospital, Toronto

T2N 4Z6

University of Calgary, Calgary

N6A 5A5

London Health Sciences Centre University Hospital, London

H4A 3J1

McGill University Health Centre - Royal Victoria Hospital, Montreal

04103

Universitatsklinikum Leipzig, Leipzig

1081 HV

Amsterdam UMC - VU Medisch Centrum (VUmc), Amsterdam

9713 GZ

Universitair Medisch Centrum Groningen, Groningen

6525 GA

Radboud University Medical Centre (MC), Nijmegen

3015 GD

Erasmus University Medical Center, Rotterdam

08036

Hospital Clinic Barcelona, Barcelona

NW3 2QG

Royal Free Hospital, London

OX3 9DU

John Radcliffe Hospital, Oxford

BT12 6BA

Royal Victoria Hospital, Belfast

B15 2TH

University Hospitals Birmingham NHS Foundation Trust - Wellcome Trust Birmingham Clinical Research Facility, Birmingham

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital, Cambridge

EH164SA

Lothian NHS Board, Edinburgh

LS9 7TF

St James' University Hospital Leeds Teaching Hospitals NHS Trust, Leeds

SE5 9RS

King's College Hospital NHS Foundation Trust, London

NE1 4LP

The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary, Newcastle upon Tyne

NG7 2FT

Nottingham University Hospital NHS Trust, Nottingham

Sponsors
All Listed Sponsors
lead

Mirum Pharmaceuticals, Inc.

INDUSTRY