We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890120
Recruitment Status : Terminated (Following recommendation of the external Data Monitoring Committee, after it reviewed the results of a planned interim futility analysis.)
First Posted : March 26, 2019
Last Update Posted : January 23, 2023
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 419 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
Actual Primary Completion Date : September 26, 2022
Actual Study Completion Date : December 23, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Blinded Phase: Cilofexor
Cilofexor for 96 weeks
 Drug: Cilofexor
100 mg tablet administered orally once daily
Other Name: 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 Name: GS-9674


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Proportion of Participants With Progression of Liver Fibrosis at Blinded Phase Week 96 [ Time Frame: Blinded Phase 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 blinded phase Week 96 will be presented.


Secondary Outcome Measures :
  1. Percentage of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 4 years ]
  2. Percentage of Participants Experiencing Serious Adverse Events (SAE [ Time Frame: Up to 4 years ]
  3. Change From Baseline in Serum Concentrations of Alkaline Phosphatase (ALP) at Blinded Phase Week 96 [ Time Frame: Baseline; Blinded Phase Week 96 ]
  4. Change From Baseline in Serum Concentrations of Alanine Aminotransferase (ALT) at Blinded Phase Week 96 [ Time Frame: Baseline; Blinded Phase Week 96 ]
  5. Change From Baseline in Serum Concentrations of Bile Acids at Blinded Phase Week 96 [ Time Frame: Baseline; Blinded Phase Week 96 ]
  6. 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 at Blinded Phase Week 96 [ Time Frame: Baseline; Blinded Phase Week 96 ]
  7. Proportion of Participants With Fibrosis Improvement According to the Ludwig Classification at Blinded Phase Week 96 [ Time Frame: Blinded Phase Week 96 ]
  8. Change From Baseline in Primary Sclerosing Cholangitis (PSC) Symptoms - Module 1 based on disease-specific Patient Reported Outcome (PSC-PRO) at Blinded Phase Week 96 [ Time Frame: Baseline; Blinded Phase Week 96 ]
  9. Change From Baseline in Enhanced Liver Fibrosis (ELF™ ) Test Score at Blinded Phase Week 96 [ Time Frame: Baseline; Blinded Phase Week 96 ]
  10. Change From Baseline in Liver Stiffness by FibroScan® at Blinded Phase Week 96 [ Time Frame: Baseline; Blinded Phase Week 96 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Show Show 201 study locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Layout table for investigator information
Study Director: Gilead Study Director Gilead Sciences
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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: January 23, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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