Study of Cilofexor in Adults With Primary Sclerosing Cholangitis
Purpose
The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).
Condition
- Primary Sclerosing Cholangitis
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Diagnosis of large duct PSC - Liver biopsy at screening that is deemed acceptable for interpretation and demonstrates stage F0 - F3 fibrosis in the opinion of the central reader - Individual has the following laboratory parameters at the screening visit, as determined by the central laboratory: - Platelet count ≥ 150,000/mm^3 - Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation - Alanine transaminase (ALT) ≤ 8 x upper limit of the normal range (ULN) - Total bilirubin < 2 mg/dL, unless the individual is known to have Gilbert's syndrome or hemolytic anemia - International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation - Negative anti-mitochondrial antibody
Exclusion Criteria
- Current or prior history of any of the following: - Cirrhosis - Liver transplantation - Cholangiocarcinoma or hepatocellular carcinoma (HCC) - Ascending cholangitis within 30 days of screening - Presence of a percutaneous drain or biliary stent - Other causes of liver disease - Current or prior history of unstable cardiovascular disease - Current moderate to severe inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, and indeterminate colitis) Note: Other protocol defined Inclusion/Exclusion criteria may apply
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Cilofexor 100 mg (Blinded Phase) |
Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks. |
|
Placebo Comparator Placebo (Blinded Phase) |
Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks. |
|
Experimental Cilofexor From Cilofexor 100 mg (OLE Phase) |
Participants who received cilofexor in blinded phase and had entered the open-label extension (OLE) phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 44.7 weeks. |
|
Experimental Cilofexor From Placebo (OLE Phase) |
Participants who received placebo in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 45.0 weeks. |
|
More Details
- Status
- Terminated
- Sponsor
- Gilead Sciences