NCT03124108

Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg After 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis and Inadequate Response to Ursodeoxycholic Acid

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Genfit · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA).

Conditions

• Primary Biliary Cholangitis (PBC)

Interventions

Type	Name	Description
DRUG	Elafibranor 80 mg	Two coated tablets daily for 12 weeks
DRUG	Elafibranor 120 mg	Two coated tablets daily for 12 weeks
DRUG	Placebo	Two coated tablets daily for 12 weeks

Timeline

• Start date: 2017-04-05
• Primary completion: 2018-10-31
• Completion: 2018-10-31
• First posted: 2017-04-21
• Last updated: 2019-09-24
• Results posted: 2019-09-24

Locations

24 sites across 5 countries: United States, France, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated drug study