OVERVIEW
A Phase 2 Proof-of-Concept Study With a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Active Treatment Extension Period to Assess the Safety and Efficacy of Seladelpar and Cilofexor in Combination for Primary Biliary Cholangitis
PROTOCOL SUMMARY
The goal of this clinical study is to learn more about the combination of study drugs seladelpar and cilofexor. The study will assess, the safety, tolerability, and effectiveness of the combination drugs versus both seladelpar alone and placebo, in participants with primary biliary cholangitis (PBC). The primary objective of this study is to determine whether the combination of seladelpar + cilofexor leads to greater alkaline phosphatase (ALP) reduction than seladelpar alone and describe the safety and tolerability of seladelpar + cilofexor.
View moreParticipation requirements
Age
18 years - 75 years
Sex
All
Healthy Volunteers
No
Age
18 years - 75 years
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Primary Biliary Cholangitis
Gender
N/A
Date
October 2026 - December 2028
Study Type
Interventional
Study Phase
Phase 2
Product
Seladelpar, PTM Seladelpar, Cilofexor Dose B, PTM Cilofexor Dose A, PTM Cilofexor Dose B, Cilofexor Dose A
Eligibility information
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
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.
Locations
Locations (4)
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907
Florida Research Institute
Lakewood Rch, Florida, United States, 34211
Digestive Healthcare of Georgia
Atlanta, Georgia, United States, 30327
GI Associates of Northeast Tennessee
Johnson City, Tennessee, United States, 37604
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