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NCT06383403 · ClinicalTrials.gov registry record · Phase 3
A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
A Phase 3 study of Primary Biliary Cholangitis, sponsored by Ipsen.
- Active
- Registry status
- Phase 3
- Development phase
- 69
- Enrollment target
- 20
- Study locations
NCT06383403 is a Phase 3 study of Primary Biliary Cholangitis that is active but no longer recruiting, run by Ipsen. The registered enrollment target is 69 participants, below the 198-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT06383403, a Phase 3 study of Primary Biliary Cholangitis, is active but no longer recruiting, sponsored by Ipsen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 69 participants
- Enrollment target
- 20
- Study locations
Study Summary
The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease. Primary biliary cholangitis is a slowly progressive disease characterised by damage of 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 scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many patients with PBC may require a 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). The main aim of this study is to determine if elafibranor is better than placebo in reducing ALP levels to a normal value. High ALP levels in the blood can indicate liver disease. There will be three periods in this study: A screening period (up to 8 weeks) to assess whether the participant can take part; a treatment period (up to 52 weeks) where eligible participants will be grouped as per their blood ALP levels and randomly assigned to either receive elafibranor or placebo, and a follow-up period (4 weeks) where participants' health will be monitored. Participants will be twice as likely to receive elafibranor than placebo (2:1 ratio). Participants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), ultrasound examinations (a noninvasive test that passes a probe over skin to look at the bladder, urinary tract, and liver), and Fibroscan® examinations (a noninvasive test that passes a probe on skin to measure stiffness of the liver). They will also be asked to fill in questionnaires. Each participant will be in this study for up to 64 weeks (15 months).
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Elafibranor
Study Locations (20)
California
- Southern California Research Center - Coronado
- Topgraphy Health, Inc. - Los Angeles
- University of California, Davis - Sacramento
- Stanford University Medical Center - Stanford
Texas
- Methodist Transplant Physicians - Dallas
- American Research Corporation at The Texas Liver Institute - San Antonio
- American Research Corporation - San Antonio
Colorado
- Peak Gastroenterology Associates - Colorado Springs
- Rocky Mountain Gastroenterology - Littleton
Michigan
- University of Michigan Health System - Ann Arbor
- Huron Gastroenterology Associates - Center for Digestive Care - Ypsilanti
North Carolina
- Charlotte Gastroenterology & Hepatology, PLLC - Charlotte
- Coastal Research Institute - Fayetteville
Florida
- International Center for Research - Tampa
Louisiana
- Delta Research Partners, LLC - West Monroe
New Jersey
- South Denver Gastroenterology,P.C. - Englewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2024-07-09 |
| Est. Completion | 2026-06-26 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06383403
The ClinicalTrials.gov registry entry for NCT06383403 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 198-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (65% lower). The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Biliary Cholangitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06383403 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Texas, Colorado.
Frequently Asked Questions
What is clinical trial NCT06383403 about?
NCT06383403 is a clinical study titled "A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.". The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease. Primary biliary cholangitis is a slowly progressive disease characterised by damage...
What is the current status of trial NCT06383403?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 69 participants. The study started on 2024-07-09. Estimated completion is 2026-06-26.
What conditions does trial NCT06383403 study?
This clinical trial studies the following conditions: Primary Biliary Cholangitis.
What interventions are being tested in trial NCT06383403?
The interventions under investigation include: Placebo (OTHER), Elafibranor (DRUG).
Who is sponsoring clinical trial NCT06383403?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06383403 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Louisiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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