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FXR Agonist
Study of Cilofexor in Adults With Primary Sclerosing Cholangitis (PRIMIS Trial)
Phase 3
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first dose date in the blinded phase up to 100.3 weeks plus 30 days
Awards & highlights
Pivotal Trial
Summary
This trial is testing cilofexor, a medication that may help prevent liver damage from getting worse. It focuses on adults with a liver disease who do not yet have severe liver damage. The medication works by reducing inflammation and scarring in the liver.
Eligible Conditions
- Primary Sclerosing Cholangitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first dose date in the blinded phase up to 100.3 weeks plus 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first dose date in the blinded phase up to 100.3 weeks plus 30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants With Progression of Liver Fibrosis at Blinded Phase Week 96
Secondary study objectives
Change From Baseline in Enhanced Liver Fibrosis (ELF™ ) Test Score at Blinded Phase Week 96
Change From Baseline in Liver Stiffness by FibroScan® at Blinded Phase Week 96
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
+6 moreSide effects data
From 2020 Phase 2 trial • 52 Patients • NCT0294346043%
Pruritus
30%
Nasopharyngitis
15%
Headache
13%
Fatigue
11%
Abdominal pain upper
11%
Arthralgia
11%
Nausea
9%
Influenza
9%
Abdominal discomfort
9%
Diarrhoea
9%
Abdominal pain
9%
Abdominal distension
6%
Gastrooesophageal reflux disease
6%
Blood bilirubin increased
6%
Pyrexia
6%
Cholangitis
6%
Paraesthesia
4%
Dyspepsia
4%
Back pain
4%
Vomiting
4%
Aspartate aminotransferase increased
4%
Hepatic enzyme increased
4%
Pain in extremity
4%
Oropharyngeal pain
4%
Blood alkaline phosphatase increased
4%
Dizziness
4%
Rash
4%
Bile duct obstruction
4%
Muscle spasms
4%
Sinusitis
4%
Upper respiratory tract infection
4%
Chills
2%
Chest pain
2%
Decreased appetite
2%
Flank pain
2%
Meniscus injury
2%
Type 2 diabetes mellitus
2%
Alanine aminotransferase increased
2%
Urticaria
2%
Viral infection
2%
Cholangitis sclerosing
2%
Sepsis
2%
Abdominal pain lower
2%
Pouchitis
2%
Hyperbilirubinaemia
2%
Gamma-glutamyltransferase increased
2%
Faeces pale
2%
Flatulence
2%
Seizure
2%
Organising pneumonia
2%
Dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cilofexor 100 mg (Open Label Extension Phase)
Placebo (Blinded Phase)
Cilofexor 30 mg (Blinded Phase)
Cilofexor 100 mg (Blinded Phase)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Cilofexor From Placebo (OLE Phase)Experimental Treatment1 Intervention
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.
Group II: Cilofexor From Cilofexor 100 mg (OLE Phase)Experimental Treatment1 Intervention
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.
Group III: Cilofexor 100 mg (Blinded Phase)Experimental Treatment1 Intervention
Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
Group IV: Placebo (Blinded Phase)Placebo Group1 Intervention
Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cilofexor
2019
Completed Phase 2
~340
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,137 Previous Clinical Trials
867,564 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
361 Previous Clinical Trials
191,934 Total Patients Enrolled