A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis. (NCT05627362)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. The following inclusion criteria apply to entry into the double-blind period and initial open-label extension (OLE) period up to OLE Week 96, unless otherwise specified.
2. Participants with a diagnosis of Primary sclerosing cholangitis (PSC) as demonstrated by the presence of the following, and in the absence of apparent causes of secondary sclerosing cholangitis: i) Historical evidence of an elevated Alkaline phosphatase (ALP) \> Upper Limit Normal (ULN) since at least 6 months prior to SV1. ii) Cholangiogram (e.g. magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), percutaneous transhepatic cholangiography (PTC) with features compatible with large duct PSC.
3. ALP ≥1.5x ULN during screening (with variability ≤30% based on two values).
4. Total bilirubin ≤2.0x ULN at Screening Visit 1(SV1)
5. Participants taking ursodeoxycholic acid (UDCA) at a total daily dose ≤23 mg/kg/day, with a minimum of 6 months of stable treatment prior to screening period and expected to remain on stable dose through the 12-week DBP. Minimum of 3 months off treatment prior to screening period if UDCA was recently discontinued.
6. For participants with Inflammatory bowel disease (IBD): i) Participants with Crohn's disease must be in remission based on the investigator's clinical assessment and should be on stable treatment prior to randomisation and during screening. ii) Participants with ulcerative colitis must be in remission or have low activity disease as per the judgement of the investigator and should be on stable treatment prior to randomisation and during screening. iii) Current treatment for IBD is permitted, if the participant has been well controlled for ≥3 months prior to the screening period and is anticipated to remain on a stable dose of drugs for IBD treatment, including biologics, immunosuppressants, immunomodulators, or systemic corticosteroids. iv) Participants with IBD should have a colonoscopy performed within one year prior to the screening period showing no evidence of dysplasia or cancer.
7. Medications for management of pruritus (e.g. cholestyramine, rifampin, naltrexone or sertraline) must be on a stable dose for ≥3 months prior to the screening period.
8. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. -A female participant is eligible to participate if she is not pregnant or breastfeeding at screening, is willing not to become pregnant during the study and is willing to follow applicable protocol requirements related to this. - Male participants are eligible to participate if they agree to follow applicable protocol requirements related to contraception.
9. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Inclusion Criteria for Entry into Optional Open-Label Extension Long-Term (OLE-LT) Period Beyond Week 96 For entry into the optional OLE-LT period, participants:
10. Must have completed the initial OLE period up to OLE Week 96
11. Must not have permanently discontinued the study intervention during the initial OLE period
12. Must, in the opinion of the investigator, benefit from continuing to receive study intervention The eligibility criteria assessed at Screening Visit 1 (SV1) for entry into the double-blind period are not reassessed for entry into the optional OLE-LT period. Contraception requirements applicable during the OLE-LT period:

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (62 Sites)

• Om Research LLC — Lancaster, California
• Cedars-Sinai Medical Center — Los Angeles, California
• University of California, Davis — Sacramento, California
• Sutter Health Van Ness Campus Medical Office Building — San Francisco, California
• Peak Gastroenterology Associates — Colorado Springs, Colorado
• South Denver Gastroenterology,P.C. — Englewood, Colorado
• Rocky Mountain Gastroenterology (RMG) — Littleton, Colorado
• Yale University School Of Medicine - Yale Center For Clinical Investigation — New Haven, Connecticut
• Schiff Center for Liver Diseases - University of Miami — Miami, Florida
• Covenant Research — Sarasota, Florida
• Piedmont Hospital - Piedmont Transplant Institute — Atlanta, Georgia
• Tandem Clinical Research GI — Marrero, Louisiana
• Mercy Medical Center — Baltimore, Maryland
• Beth Israel Deaconess Medical Center, Liver Research Center — Boston, Massachusetts
• Huron Gastroenterology Associates - Center for Digestive Care — Ypsilanti, Michigan
• University of Nebraska Medical Center — Omaha, Nebraska
• Southwest Gastroenterology Associates, PC (SWGA) — Albuquerque, New Mexico
• New York University Langone Health — New York, New York
• Gastro Health Research — Cincinnati, Ohio
• Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania
• Thomas Jefferson University — Philadelphia, Pennsylvania
• Medical University of South Carolina — Charleston, South Carolina
• Gastro One — Cordova, Tennessee
• University Of Texas Southwestern Medical Center At Dallas — Dallas, Texas
• American Research Corporation at The Texas Liver Institute — San Antonio, Texas

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.