A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

September 9, 2015

Primary Completion Date

August 2, 2018

Study Completion Date

August 2, 2018

Conditions
Primary Biliary Cholangitis
Interventions
DRUG

Part 1: LJN452

LJN452 capsules administered once daily for 28 days

DRUG

Part 1: Placebo

Matching placebo capsules administered once daily for 28 days

DRUG

Part 2: LJN452 Dose level 1

LJN452 capsules administered once a day for 12 weeks

DRUG

Part 2: Placebo

Matching placebo to LJN452 administered once a day for 12 weeks

DRUG

Part 2: LJN452 Dose level 2

LJN452

Trial Locations (28)

11030

Novartis Investigative Site, Manhasset

20246

Novartis Investigative Site, Hamburg

30060

Novartis Investigative Site, Marietta

30308

Novartis Investigative Site, Atlanta

30625

Novartis Investigative Site, Hanover

33136

Novartis Investigative Site, Miami

60612

Novartis Investigative Site, Chicago

69120

Novartis Investigative Site, Heidelberg

75390

Novartis Investigative Site, Dallas

78215

Novartis Investigative Site, San Antonio

81377

Novartis Investigative Site, München

92377

Novartis Investigative Site, Rialto

97080

Novartis Investigative Site, Würzburg

98104

Novartis Investigative Site, Seattle

117198

Novartis Investigative Site, Moscow

194044

Novartis Investigative Site, Saint Petersburg

443011

Novartis Investigative Site, Samara

T2N 4N1

Novartis Investigative Site, Calgary

T6G 2B7

Novartis Investigative Site, Edmonton

91-347

Novartis Investigative Site, Lodz

41-400

Novartis Investigative Site, Mysłowice

02-097

Novartis Investigative Site, Warsaw

50-449

Novartis Investigative Site, Wroclaw

B15 2TH

Novartis Investigative Site, Birmingham

CB2 2QQ

Novartis Investigative Site, Cambridge

HU3 2JZ

Novartis Investigative Site, Hull

NW3 2PF

Novartis Investigative Site, London

NE1 4LP

Novartis Investigative Site, Newcastle upon Tyne

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY