Seladelpar and Cilofexor in Primary Biliary Cholangitis (PBC)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional study compares the combination of seladelpar and cilofexor versus seladelpar alone and placebo in adults with primary biliary cholangitis. Participants will be assigned to receive either the combination therapy, seladelpar alone, or placebo, to evaluate safety, tolerability, and the effect on alkaline phosphatase levels. The primary goal is to see if the combination reduces ALP more than seladelpar alone. Key eligibility includes documented PBC, prior UDCA use or intolerance, and elevated ALP. Exclusion criteria include other liver diseases and advanced cirrhosis. The study is sponsored by Gilead Sciences with sites in Colorado, Florida, and Georgia.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Have a diagnosis of primary biliary cholangitis (PBC) as defined by a history of any 2 of the following criteria:

  1. ALP above 1.0 × the ULN for at least 6 months
  2. Positive antimitochondrial antibody titer (\> 1:40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or positive PBC-specific antinuclear antibodies
  3. Documented liver biopsy results consistent with PBC
* Used ursodeoxycholic acid (UDCA) for the past 12 months (stable dose for \> 6 months prior to screening), or intolerant to UDCA (last dose of UDCA \> 90 days prior to screening)
* Have an ALP ≥ 1.67 × ULN at screening
* Have a negative serum pregnancy test at screening

Key Exclusion Criteria:

* Have other causes of liver disease including viral, alcoholic, autoimmune, and metabolic associated steatohepatitis (MASH).
* Cirrhosis with Child-Pugh Score ≥ 7, corresponding to Class B or C. Individuals with compensated cirrhosis (ie, Child-Pugh Class A) are allowed if they meet all other criteria.
* Have evidence of portal hypertension or clinically important hepatic decompensation (historic or current), including but not limited to: hepatic encephalopathy, known esophageal or gastric varices, history of liver transplantation, current placement on liver transplant list, Model for End Stage Liver Disease score ≥ 12, ascites, spontaneous bacterial peritonitis, hepatorenal syndrome.
* Have previous exposure to seladelpar or cilofexor
* Used obeticholic acid, fenofibrate, bezafibrate, elafibranor, pemafibrate, or saroglitazar within 6 weeks (42 days, inclusive) of screening date
* Require or expect to require treatment with ≥ 5 mg prednisone (or systemic equivalents) for \> 2 weeks during the study
* Are on any systemic drug for antipruritic treatment that has required a dose adjustment in the 30 days before screening, or initiated a systemic antipruritic drug in the 30 days before screening

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it's running

• Peak Gastroenterology Associates
  Colorado Springs, Colorado, United States Recruiting
• Florida Research Institute
  Lakewood Rch, Florida, United States Recruiting
• Digestive Healthcare of Georgia
  Atlanta, Georgia, United States Recruiting
• GI Associates of Northeast Tennessee
  Johnson City, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Gilead Clinical Study Information Center
• Email: GileadClinicalTrials@gilead.com
• Phone: 1-833-445-3230 (GILEAD-0)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Austrian PBC Registry

  This registry follows adults with primary biliary cholangitis in Austrian centers to see how the disease develops over time and how biomarkers relate to complications and symptoms.

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• Biochemical response and health outcomes in people with primary biliary cholangitis

  We will follow adults with primary biliary cholangitis who are taking ursodeoxycholic acid (UDCA) to see if their alkaline phosphatase levels after treatment predict how long they stay free of complications.

  Recruiting RenJi Hospital · Shanghai, Shanghai Municipality · NCT07449793

• Saroglitazar Magnesium for PBC with incomplete UDCA response or intolerance

  This study tests whether Saroglitazar Magnesium can help people with primary biliary cholangitis who still have high alkaline phosphatase despite UDCA or cannot take UDCA.

  Recruiting Phase 3 Zydus Therapeutics Inc. · Lakewood Rch, Florida · NCT07424677

• CS0159 for primary biliary cholangitis when UDCA doesn't work or isn't tolerated.

  This test tries to see if taking CS0159 once daily helps adults with primary biliary cholangitis who have an inadequate response to or cannot tolerate UDCA.

  Recruiting at 39 sites Phase 3 Cascade Pharmaceuticals, Inc · Hefei, Anhui and 41 other locations · NCT07282353

• Saroglitazar Magnesium-V as add-on therapy for primary biliary cholangitis

  This trial tests whether Saroglitazar Magnesium-V, compared with placebo, can improve long-term clinical outcomes in adults with primary biliary cholangitis who are on UDCA.

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• LEOPARD: Predicting liver transplant dropout with AI in European patients

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.