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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03890120
Registration number
NCT03890120
Ethics application status
Date submitted
25/03/2019
Date registered
26/03/2019
Titles & IDs
Public title
Study of Cilofexor in Adults With Primary Sclerosing Cholangitis
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Scientific 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
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Secondary ID [1]
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2019-000204-14
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Secondary ID [2]
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GS-US-428-4194
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Universal Trial Number (UTN)
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Trial acronym
PRIMIS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Primary Sclerosing Cholangitis
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Infection
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cilofexor
Treatment: Drugs - Placebo
Experimental: Cilofexor 100 mg (Blinded Phase) - Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
Placebo comparator: Placebo (Blinded Phase) - Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
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.
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.
Treatment: Drugs: Cilofexor
100 mg tablet administered orally once daily
Treatment: Drugs: Placebo
Tablet administered orally once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Progression of Liver Fibrosis at Blinded Phase Week 96
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Assessment method [1]
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Progression of liver fibrosis was defined as having a = 1-stage increase from baseline in fibrosis according to the Ludwig classification at Blinded Phase Week 96. The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).
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Timepoint [1]
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Blinded Phase Week 96
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Secondary outcome [1]
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Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) in The Blinded Phase
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Assessment method [1]
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An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. For Blinded Study Phase and OLE Phase, TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug.
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Timepoint [1]
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First dose date in the Blinded Phase up to 100.3 weeks plus 30 days
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Secondary outcome [2]
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Percentage of Participants Who Experienced TEAEs in The OLE Phase
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Assessment method [2]
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An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. For Blinded Study Phase and OLE Phase, TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug.
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Timepoint [2]
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First dose date in the OLE Phase up to 45 weeks plus 30 days
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Secondary outcome [3]
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Percentage of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs) in the Blinded Phase
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Assessment method [3]
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An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
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Timepoint [3]
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First dose date in the Blinded Phase up to 100.3 weeks plus 30 days
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Secondary outcome [4]
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Percentage of Participants Who Experienced Treatment-emergent SAEs in the OLE Phase
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Assessment method [4]
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An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
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Timepoint [4]
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First dose date in the OLE Phase up to 45 weeks plus 30 days
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Secondary outcome [5]
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Change From Baseline in Serum Concentrations of Alkaline Phosphatase (ALP) at Blinded Phase Week 96
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Assessment method [5]
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Timepoint [5]
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Baseline, Blinded Phase Week 96
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Secondary outcome [6]
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Change From Baseline in Serum Concentrations of Alanine Aminotransferase (ALT) at Blinded Phase Week 96
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Assessment method [6]
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Timepoint [6]
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Baseline, Blinded Phase Week 96
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Secondary outcome [7]
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Change From Baseline in Serum Concentrations of Fasting Total Bile Acids at Blinded Phase Week 96
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Assessment method [7]
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Timepoint [7]
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Baseline, Blinded Phase Week 96
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Secondary outcome [8]
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Percentage 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
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Assessment method [8]
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The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).The percentage of participants with = 25% reduction in serum ALP Concentration from baseline and no increase in fibrosis according to the Ludwig Classification at Blinded Phase Week 96 was analyzed.
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Timepoint [8]
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Baseline, Blinded Phase Week 96
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Secondary outcome [9]
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Percentage of Participants With Fibrosis Improvement According to the Ludwig Classification at Blinded Phase Week 96
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Assessment method [9]
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Fibrosis improvement was defined as having = 1-stage decrease from baseline in fibrosis according to the Ludwig classification score at Blinded Study Phase Week 96. The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).
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Timepoint [9]
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Blinded Phase Week 96
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Secondary outcome [10]
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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
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Assessment method [10]
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The PSC-PRO addressed the severity of common everyday symptoms of PSC (eg, pruritus, fatigue, and right upper quadrant abdominal discomfort); and their functional impact (eg, on physical function, activities of daily living, and work productivity, etc). PSC-PRO module 1 - PSC symptoms contains a total of 12 questions asking about the severity of specific PSC symptoms on a scale of 0 (no symptoms) to 10 (symptoms as bad as you could imagine) with a 24-hour recall period. The total score, which is computed as 12 times the average of nonmissing scores of the 12 questions, can potentially range between 0 and 120, with higher scores indicating more severe symptoms. A positive change from baseline indicates worsening of symptoms.
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Timepoint [10]
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Baseline, Blinded Phase Week 96
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Secondary outcome [11]
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Change From Baseline in Enhanced Liver Fibrosis (ELF™ ) Test Score at Blinded Phase Week 96
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Assessment method [11]
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The Enhanced Liver Fibrosis (ELF™) test is a composite of three serum biomarkers of hepatobiliary fibrosis: hyaluronic acid, procollagen III amino-terminal peptide, and tissue inhibitor of metalloproteinase. A typical range for ELF™ test scores in PSC is between 6 and 14. Higher ELF™ test scores are associated with more severe liver disease. A positive change from baseline indicated worsening of fibrosis.
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Timepoint [11]
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Baseline, Blinded Phase Week 96
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Secondary outcome [12]
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Change From Baseline in Liver Stiffness by FibroScan® at Blinded Phase Week 96
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Assessment method [12]
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Change in liver stiffness was measured by FibroScan® scores. FibroScan measures liver scarring by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. Higher scores indicate increased scarring of the liver. A positive change from baseline indicates severe liver disease(s).
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Timepoint [12]
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Baseline, Blinded Phase Week 96
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Eligibility
Key inclusion criteria
Key
* 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
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Minimum age
18
Years
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/03/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/12/2022
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Sample size
Target
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Accrual to date
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Final
419
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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St. Vincent's Hospital Sydney - Darlinghurst
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Nepean Hospital - Penrith
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Westmead Hospital - Westmead
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Coral Sea Clinical Research Institute - Mackay - Auchenflower
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Royal Brisbane and Women's Hospital - Herston
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Mater Misericordiae Ltd - South Brisbane
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Monash Health - Clayton
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Austin Health - Heidelberg
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The Alfred Hospital - Melbourne
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The Royal Melbourne Hospital - Parkville
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Sir Charles Gairdner Hospital - Nedlands
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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2751 - Penrith
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2145 - Westmead
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4066 - Auchenflower
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Recruitment postcode(s) [6]
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4029 - Herston
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Recruitment postcode(s) [7]
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4101 - South Brisbane
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3168 - Clayton
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3084 - Heidelberg
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3004 - Melbourne
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Recruitment postcode(s) [11]
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3050 - Parkville
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Recruitment postcode(s) [12]
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6009 - Nedlands
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Recruitment postcode(s) [13]
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6000 - Perth
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Recruitment outside Australia
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Italy
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Foggia
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Italy
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Novara
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Italy
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Rozzano
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Japan
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Chiba-shi
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Japan
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Hiroshima
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Nagasaki
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Japan
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Sendai
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Suita
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Tokyo
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Yamagata
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Auckland
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Hamilton
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Spain
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Alicante
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Barcelona
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Madrid
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Pontevedra
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Spain
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Santiago de Compostela
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Valencia
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Zaragoza
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Bern
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Lugano
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Birmingham
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Cambridge
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Glasgow
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Leeds
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Liverpool
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London
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Nottingham
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Oxford
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United Kingdom
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Portsmouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT03890120
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Trial related presentations / publications
Trauner M, Chung C, Sterling K, Liu X, Lu X, Xu J, Tempany-Afdhal C, Goodman ZD, Farkkila M, Tanaka A, Trivedi P, Kowdley KV, Bowlus CL, Levy C, Myers RP. PRIMIS: design of a pivotal, randomized, phase 3 study evaluating the safety and efficacy of the nonsteroidal farnesoid X receptor agonist cilofexor in noncirrhotic patients with primary sclerosing cholangitis. BMC Gastroenterol. 2023 Mar 15;23(1):75. doi: 10.1186/s12876-023-02653-2. Trauner M, Levy C, Tanaka A, Goodman Z, Thorburn D, et al. A Phase 3 Randomized, Double-blind, Placebo-controlled Study Evaluation the Efficacy and Safety of Cilofexor in Patients With Non-cirrhotic Patients With Primary Sclerosing Cholangitis. J Hepatol. 2023 June;78(S1):S12-S13.
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Public notes
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Contacts
Principal investigator
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Gilead Study Director
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Gilead Sciences
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/20/NCT03890120/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/20/NCT03890120/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03890120