A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

December 29, 2022

Primary Completion Date

August 28, 2026

Study Completion Date

August 28, 2026

Conditions
Primary Sclerosing Cholangitis
Interventions
DRUG

Elafibranor 80 mg

Oral Tablet

DRUG

Elafibranor 120 mg

Oral Tablet

DRUG

Placebo Matched to Elafibranor 80 mg

Oral Tablet

DRUG

Placebo Matched to Elafibranor 120 mg

Oral Tablet

Trial Locations (62)

13353

Charite Campus Virchow, Berlin

17033

Penn State Milton S Hershey Medical Center, Hershey

19017

Thomas Jefferson University, Philadelphia

20089

Gruppo Humanitas - Humanitas Research Hospital, Istituto Clinico Humanitas, Rozzano

21202

Mercy Medical Center, Baltimore

22093

University of Virginia Medical Center, Charlottesville

23226

Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond, Richmond

23298

Virginia Commonwealth University, Richmond

28007

Hospital General Universitario Gregorio Maranon (HGUGM), Madrid

28046

Hospital Universitario La Paz, Madrid

28222

Hospital Universitario Puerta de Hierro, Majadahonda

29425

Medical University of South Carolina, Charleston

30309

Piedmont Hospital - Piedmont Transplant Institute, Atlanta

33136

Schiff Center for Liver Diseases - University of Miami, Miami

34240

Covenant Research, Sarasota

35128

Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia, Padua

36071

Hospital De Montecelo, Pontevedra

38018

Gastro One, Cordova

41124

Azienda Ospedaliero Universitaria Modena, Modena

45219

Gastro Health Research, Cincinnati

47012

Hospital Universitario Rio Hortega, Valladolid

48197

Huron Gastroenterology Associates - Center for Digestive Care, Ypsilanti

50009

Hospital Universitario Miguel Servet, Zaragoza

60590

Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt, Frankfurt

68198

University of Nebraska Medical Center, Omaha

69120

Universitaetsklinikum Heidelberg - Nationales Centrum fuer Tumorerkrankungen, Heidelberg

70072

Tandem Clinical Research GI, Marrero

71013

Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo

75235

University Of Texas Southwestern Medical Center At Dallas, Dallas

78215

American Research Corporation at The Texas Liver Institute, San Antonio

80113

South Denver Gastroenterology,P.C., Englewood

80120

Rocky Mountain Gastroenterology (RMG), Littleton

80907

Peak Gastroenterology Associates, Colorado Springs

84107

Intermountain Medical Center, Murray

89081

University Hospital Ulm, Ulm

90048

Cedars-Sinai Medical Center, Los Angeles

90127

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo

93534

Om Research LLC, Lancaster

94109

Sutter Health Van Ness Campus Medical Office Building, San Francisco

95817

University of California, Davis, Sacramento

98105

Liver Institute Northwest, Seattle

06510

Yale University School Of Medicine - Yale Center For Clinical Investigation, New Haven

New York University Langone Health, New York

02215

Beth Israel Deaconess Medical Center, Liver Research Center, Boston

87109-4342

Southwest Gastroenterology Associates, PC (SWGA), Albuquerque

T2N 4Z6

University of Calgary, Calgary

T6G 2X8

University Of Alberta Hospital-Zeidler Ledcor Centre, Edmonton

L6R 3J7

Brampton Civic Hospital (BCH) - Osler Hepatitis Centre, Brampton

T3H 0V5

Aspen Woods Clinic, Calgary

H2X 0A9

Centre de Recherche du Centre Hospitalier de l'Universite de Montreal, Montreal

V6Z 2K5

G.I Research Institute, Vancouver

4800-055

Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira, Guimarães

1345-035

Centro Hospitalar Universitario Lisboa Norte, Lisbon

1349-019

Centro Hospitalar de Lisboa ocidental (CHLO), Hospital Egas Moniz, Lisbon

08035

Hospital Universitario Vall d'Hebron, Barcelona

AB25 2ZD

Aberdeen Royal Infirmary NHS Grampian Grampian Health Board, Aberdeen

B15 2TT

Queen Elizabeth Hospital, Birmingham

GU16 7UJ

Frimley Park Hospital - Frimley Health NHS Foundation Trust, Frimley

G4 0SF

Glasgow Royal Infirmary - Greater Glasgow Health Board, Glasgow

HU3 2JZ

Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust, Hull

E1 1BB

Ambrose King Centre-Royal London Hospital-Barts Health NHS Trust, London

NW3 2QG

The Royal Free Hospital - Royal Free London NHS Foundation Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ipsen

INDUSTRY

NCT05627362 - A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis. | Biotech Hunter | Biotech Hunter