Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic 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 - 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

ArmDescriptionAssigned Intervention
Experimental
Blinded Phase: Cilofexor
Cilofexor for 96 weeks
  • Drug: Cilofexor
    100 mg tablet administered orally once daily
    Other names:
    • GS-9674
Placebo Comparator
Blinded Phase: Placebo
Placebo for 96 weeks
  • Drug: Placebo
    Tablet administered orally once daily
Experimental
Open-Label Phase: Cilofexor
Cilofexor for 96 weeks
  • Drug: Cilofexor
    100 mg tablet administered orally once daily
    Other names:
    • GS-9674

More Details

Status
Active, not recruiting
Sponsor
Gilead Sciences

Study Contact