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FXR Agonist

Cilofexor for 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

PRIMIS Trial Summary

This trial will test whether cilofexor can help prevent fibrosis progression in people with primary sclerosing cholangitis who don't have cirrhosis.

Eligible Conditions

Primary Sclerosing Cholangitis

PRIMIS Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose date in the blinded phase up to 100.3 weeks plus 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants With Progression of Liver Fibrosis at Blinded Phase Week 96

Secondary outcome measures

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

+9 more

Side effects data

From 2020 Phase 2 trial • 52 Patients • NCT02943460

43%

Pruritus

30%

Nasopharyngitis

15%

Headache

13%

Fatigue

11%

Arthralgia

11%

Abdominal pain upper

11%

Nausea

Abdominal discomfort

Influenza

Diarrhoea

Abdominal pain

Abdominal distension

Gastrooesophageal reflux disease

Blood bilirubin increased

Pyrexia

Cholangitis

Paraesthesia

Hepatic enzyme increased

Blood alkaline phosphatase increased

Rash

Muscle spasms

Bile duct obstruction

Dizziness

Aspartate aminotransferase increased

Vomiting

Oropharyngeal pain

Pain in extremity

Dyspepsia

Back pain

Sinusitis

Upper respiratory tract infection

Chills

Decreased appetite

Chest pain

Alanine aminotransferase increased

Flank pain

Urticaria

Type 2 diabetes mellitus

Hyperbilirubinaemia

Viral infection

Pouchitis

Abdominal pain lower

Sepsis

Cholangitis sclerosing

Meniscus injury

Gamma-glutamyltransferase increased

Faeces pale

Flatulence

Seizure

Organising pneumonia

Dermatitis

100%

80%

60%

40%

20%

Study treatment Arm

Cilofexor 100 mg (Open Label Extension Phase)

Placebo (Blinded Phase)

Cilofexor 30 mg (Blinded Phase)

Cilofexor 100 mg (Blinded Phase)

PRIMIS 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,082 Previous Clinical Trials

842,422 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,416 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial enrolling individuals who are under the age of 60?

"The age limit to participate in this trial is set between 18-75 years old. Although, there are 5 other trials patients under 18 can enroll in and 42 trials for patients over 65."

Answered by AI

Which types of patients does this clinical trial cater to?

"The current study requires that participants have a diagnosis of cholangitis and are between 18-75 years old in order to qualify. Up to 419 individuals can be enrolled in the trial."

Answered by AI

Are people with the target illness able to participate in this research project currently?

"Currently, this study is not recruiting patients. The trial was first posted on March 27th, 2019 and was edited on October 25th, 2020. There are other 41 trials for cholangitis and 2 trials for Cilofexor that are actively enrolling patients."

Answered by AI

Are there other similar clinical trials to this one?

"There are two ongoing clinical trials for Cilofexor in 147 cities across 17 countries. The first study for Cilofexor was conducted in 2019 and was sponsored by Gilead Sciences. The study included 419 patients and completed its Phase 3 drug approval stage. Since 2019, 18,247 studies have been completed."

Answered by AI

Has Cilofexor been given the okay by the FDA?

"Cilofexor's safety has been well documented in past clinical trials and thus it receives a score of 3."

Answered by AI

Are there other research papers that mention Cilofexor?

"Cilofexor was first researched at Ehime University Hospital in 2019. Since then, there have been a total of 18,247 studies completed. Currently, there are 2 ongoing trials, with a significant portion taking place in Charlottesville, Minnesota."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Cilofexor in Adults With Primary Sclerosing Cholangitis

2019. "Study of Cilofexor in Adults With Primary Sclerosing Cholangitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03890120.