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Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Adults With Primary Sclerosing Cholangitis (PRIMIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890120
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Drug: Cilofexor Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects With Primary Sclerosing Cholangitis
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cilofexor
Cilofexor for 96 weeks
 Drug: Cilofexor
100 mg tablet administered orally once daily
Other Name: GS-9674
Placebo Comparator: Placebo
Placebo for 96 weeks
 Drug: Placebo
Tablet administered orally once daily


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Participants With Progression of Liver Fibrosis at Week 96 [ Time Frame: Week 96 ]
    Progression of liver fibrosis was defined as having a ≥ 1-stage increase in fibrosis according to the Ludwig classification. The proportion of participants with progression of liver fibrosis at Week 96 will be presented.


Secondary Outcome Measures :
  1. Change From Baseline in Serum Concentrations of Alkaline Phosphatase (ALP) at Week 96 [ Time Frame: Baseline; Week 96 ]
  2. Change From Baseline in Serum Concentrations of Gamma Glutamyl Transferase (GGT) at Week 96 [ Time Frame: Baseline; Week 96 ]
  3. Change From Baseline in Serum Concentrations of Alanine Aminotransferase (ALT) at Week 96 [ Time Frame: Baseline; Week 96 ]
  4. Change From Baseline in Serum Concentrations of Bile Acids at Week 96 [ Time Frame: Baseline; Week 96 ]
  5. Composite Endpoint Measuring the Proportion of Participants With ≥ 25% Relative Reduction in Serum ALP Concentration From Baseline and No Worsening of Fibrosis According to the Ludwig Classification [ Time Frame: Week 96 ]
  6. Change From Baseline in Hepatic Collagen Content at Week 96 [ Time Frame: Baseline; Week 96 ]
  7. Proportion of Participants With Fibrosis Improvement According to the Ludwig Classification at Week 96 [ Time Frame: Week 96 ]
  8. Change From Baseline in the Primary Sclerosing Cholangitis Patient-Reported Outcome (PSC-PRO) at Week 96 [ Time Frame: Baseline; Week 96 ]
  9. Proportion of Participants With Progression to Cirrhosis (Ludwig Fibrosis Stage F4) at Week 96 [ Time Frame: Week 96 ]
  10. Change From Baseline in Enhanced Liver Fibrosis (ELF™ ) Test Score at Week 96 [ Time Frame: Baseline; Week 96 ]
  11. Change From Baseline in Liver Stiffness by FibroScan® at Week 96 [ Time Frame: Baseline; Week 96 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key 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

Key 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890120


Contacts
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Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Additional Information:

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03890120    
Other Study ID Numbers: GS-US-428-4194
2019-000204-14 ( EudraCT Number )
JapicCTI-194804 ( Registry Identifier: Japan Pharmaceutical Information Center )
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases