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

NCT02516605 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2021-01-05

Study results available
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Summary

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

Conditions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-09
Primary Completion
2018-08-02
Completion
2018-08-02
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Poland
  • Russia
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02516605 on ClinicalTrials.gov