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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 <

Brief 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).

Detailed Summary:
Sponsor: Genfit

Current Primary Outcome: Change in serum alkaline phosphatase (ALP) [ Time Frame: Measurements at Baseline and 12 weeks ]

To evaluate the efficacy of elafibranor 80 and 120 mg with respect to relative change from baseline in serum ALP levels compared to placebo


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Composite endpoint composed of ALP and total bilirubin [ Time Frame: Measurements at 12 weeks ]
    To assess response rate in elafibranor 80 mg and 120 mg and placebo groups, with response defined as ALP less than 1.67 times ULN and total bilirubin within normal limits and ALP reduction > 15%
  • Composite endpoint composed of ALP and total bilirubin [ Time Frame: Measurements at 12 weeks ]
    To assess response rate in elafibranor 80 mg and 120 mg and placebo groups, with response defined as ALP less than 2 times ULN and total bilirubin within normal limits and ALP reduction > 40%
  • Paris I PBC risk score [ Time Frame: Measurements at 12 weeks ]
    To assess response rate in elafibranor 80 mg and 120 mg and placebo groups according to Paris I PBC risk score
  • Paris II PBC risk score [ Time Frame: Measurements at 12 weeks ]
    To assess response rate in elafibranor 80 mg and 120 mg and placebo groups according to Paris II PBC risk score
  • Toronto I PBC risk score [ Time Frame: Measurements at 12 weeks ]
    To assess response rate in elafibranor 80 mg and 120 mg and placebo groups according to Toronto I PBC risk score
  • Toronto II PBC risk score [ Time Frame: Measurements at 12 weeks ]
    To assess response rate in elafibranor 80 mg and 120 mg and placebo groups according to Toronto II PBC risk score
  • UK PBC risk score [ Time Frame: Measurements at 12 weeks ]
    To assess response rate in elafibranor 80 mg and 120 mg and placebo groups according to UK PBC risk score
  • Normalization of ALP levels [ Time Frame: Measurements at 12 weeks ]
    To assess the response to elafibranor 80 mg and 120 mg versus placebo treatment on normalization of ALP
  • Liver enzymes [ Time Frame: Measurements at Baseline and 12 weeks ]
    To assess the response to elafibranor 80 mg and 120 mg versus placebo treatment on liver enzymes and liver markers
  • Fibrosis markers [ Time Frame: Measurements at Baseline and 12 weeks ]
    To assess the response to elafibranor 80 mg and 120 mg versus placebo treatment on fibrosis markers
  • Lipid parameters [ Time Frame: Measurements at Baseline and 12 weeks ]
    To assess the response to elafibranor 80 mg and 120 mg versus placebo treatment on lipid parameters
  • Inflammatory markers [ Time Frame: Measurements at Baseline and 12 weeks ]
    To assess the response to elafibranor 80 mg and 120 mg versus placebo treatment on inflammatory markers
  • Pruritis score [ Time Frame: Measurements at Baseline and 12 weeks ]
    To assess the efficacy of elafibranor 80 and 120 mg versus placebo treatment with respect to the change from baseline in pruritus (through 5D-itch scale and visual analogue score VAS)
  • Quality of Life parameters [ Time Frame: Measurements at Baseline and 12 weeks ]
    To assess the efficacy of elafibranor 80 and 120 mg versus placebo treatment with respect to the change from baseline in Quality of Life (using PBC 40 questionnaire)
  • Assess the tolerability and safety of elafibranor 80 mg and 120 mg in patients with PBC [ Time Frame: 12 weeks ]
    To monitor adverse events


Original Secondary Outcome: Same as current

Information By: Genfit

Dates:
Date Received: March 28, 2017
Date Started: April 5, 2017
Date Completion: April 2018
Last Updated: May 5, 2017
Last Verified: May 2017