A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis (ELFIDENCE)
A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants With Primary Biliary Cholangitis (PBC)
Sponsor: Ipsen
This observational or N/A phase trial investigates Primary Biliary Cholangitis (PBC) and is currently actively recruiting participants. Ipsen leads this study, which shows 27 recorded versions since 2023 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
27 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
Phase: PHASE3 → None
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Mar 2026 — May 2026 [monthly]
Recruiting PHASE3
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Feb 2026 — Mar 2026 [monthly]
Recruiting PHASE3
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Jan 2026 — Feb 2026 [monthly]
Recruiting PHASE3
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Nov 2025 — Jan 2026 [monthly]
Recruiting PHASE3
▶ Show 22 earlier versions
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Oct 2025 — Nov 2025 [monthly]
Recruiting PHASE3
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Sep 2025 — Oct 2025 [monthly]
Recruiting PHASE3
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Aug 2025 — Sep 2025 [monthly]
Recruiting PHASE3
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Jul 2025 — Aug 2025 [monthly]
Recruiting PHASE3
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Jun 2025 — Jul 2025 [monthly]
Recruiting PHASE3
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May 2025 — Jun 2025 [monthly]
Recruiting PHASE3
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Apr 2025 — May 2025 [monthly]
Recruiting PHASE3
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Mar 2025 — Apr 2025 [monthly]
Recruiting PHASE3
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Jan 2025 — Mar 2025 [monthly]
Recruiting PHASE3
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Dec 2024 — Jan 2025 [monthly]
Recruiting PHASE3
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Nov 2024 — Dec 2024 [monthly]
Recruiting PHASE3
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Oct 2024 — Nov 2024 [monthly]
Recruiting PHASE3
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Sep 2024 — Oct 2024 [monthly]
Recruiting PHASE3
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Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE3
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Jun 2024 — Jul 2024 [monthly]
Recruiting PHASE3
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May 2024 — Jun 2024 [monthly]
Recruiting PHASE3
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Apr 2024 — May 2024 [monthly]
Recruiting PHASE3
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Feb 2024 — Apr 2024 [monthly]
Recruiting PHASE3
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Jan 2024 — Feb 2024 [monthly]
Recruiting PHASE3
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Nov 2023 — Jan 2024 [monthly]
Recruiting PHASE3
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Oct 2023 — Nov 2023 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Sep 2023 — Oct 2023 [monthly]
Not Yet Recruiting PHASE3
First recorded
Aug 2023
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver). PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to cirrhosis. PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment) and will last up to 3.5 years for each participant. The main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death). This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.
Contact Information
- Ipsen
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Albuquerque, United States , Ann Arbor, United States , Arlington, United States , Athens, Greece , Athens, Greece , Athens, Greece , Aurora, United States , Austin, United States , Barcelona, Spain , Barcelona, Spain and 170 more locations