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

Conditions

• Primary Biliary Cholangitis (PBC)

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Elafibranor 80 mg — DRUG
  Two coated tablets daily for 12 weeks
• Elafibranor 120 mg — DRUG
  Two coated tablets daily for 12 weeks
• Placebo — DRUG
  Two coated tablets daily for 12 weeks

Study Details

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).

Key Dates

Start date

Apr 5, 2017

Status verified

Sep 2019

Primary completion

Oct 31, 2018

Completion

Oct 31, 2018

Study Design

Enrollment

45 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Study subjects will take two tablets per day orally before breakfast with a glass of water each morning
• Active Comparator: Elafibranor 80 mg
  Study subjects will take two tablets per day orally before breakfast with a glass of water each morning
• Active Comparator: Elafibranor 120 mg
  Study subjects will take two tablets per day orally before breakfast with a glass of water each morning

Primary Outcome Measure

Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) Levels at Week 12 (Endpoint) [ Time Frame: Baseline, Week 12 (Endpoint) ]

Locations (13)

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