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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis

Clinical Trial Details

This is a phase III, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of GS-9674 in subjects with primary sclerosing cholangitis (PSC) without cirrhosis. The study will consist of an 8-week screening period, 96 weeks of study drug intervention, and a follow-up visit 4 weeks after completion of study drug. Subjects will be randomized 2:1 to receive GS-9674 100 mg orally once daily (QD) or placebo for 96 weeks. 

The purpose of this study is to see whether the investigational/experimental drug GS-9674 slows the scarring process in individuals with PSC. GS-9674 is a potent and selective agonist (substance that binds to a receptor) of FXR, the principle sensor of bile acid homeostasis (maintenance) found in the liver and intestinal tract. Activating FXR has the potential to benefit patients with PSC by inducing FGF19 production from the intestinal tract, which then travels to the liver to reduce bile acid levels. 

If an individual agrees to participate and meets all the requirements, they will be randomized to one of the following study groups: 

  • Group A: 100 mg tablet once daily of GS-9674 for 96 weeks 
  • Group B: 100 mg tablet once daily of placebo for 96 weeks 

The placebo tablet will look like GS-9674 but will not contain active medicine/ingredients. GS-9674 and placebo will be supplied by Gilead Sciences, Inc., which is the sponsor of this study. 

Participation in this study will last about 100 weeks, not including the screening period which can last up to 8 weeks. During this time, participants will be required to visit the clinic at least 14 times including the screening visit. Participants will be compensated for their time. 

Key Eligibility: 
  • Men and women who are 18 years of age and older
  • Have been diagnosed with primary sclerosing cholangitis (PSC)
  • Detailed eligibility reviewed when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Mallory Ianelli, RN, BSN
(646) 962-4040
mai2016@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1904020136

ClinicalTrials.gov:

NCT03890120

Sponsor:

Gilead GS-US-428-4194

Status

Open to Enrollment

Age Group

Adult

Sponsor