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

ArmDescriptionAssigned Intervention
Experimental
Cilofexor 100 mg (Blinded Phase) 		Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
  • Drug: Cilofexor
    100 mg tablet administered orally once daily
    Other names:
    • GS-9674
Placebo Comparator
Placebo (Blinded Phase) 		Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
  • Drug: Placebo
    Tablet administered orally once daily
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.
  • Drug: Cilofexor
    100 mg tablet administered orally once daily
    Other names:
    • GS-9674
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.
  • Drug: Cilofexor
    100 mg tablet administered orally once daily
    Other names:
    • GS-9674

More Details

Status
Terminated
Sponsor
Gilead Sciences

Study Contact