NCT02516605

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

A Multi-part, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Efficacy of Tropifexor (LJN452) in Patients With Primary Biliary Cholangitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multi-part study to assess safety, tolerability and efficacy of tropifexor (LJN452) in patients with primary biliary cholangitis

Conditions

• Primary Biliary Cholangitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-09-09
• Primary completion: 2018-08-02
• Completion: 2018-08-02
• First posted: 2015-08-06
• Last updated: 2021-01-05
• Results posted: 2019-11-13

Locations

28 sites across 6 countries: United States, Canada, Germany, Poland, Russia, United Kingdom

Regulatory

• FDA-regulated drug study