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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

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

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

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 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

Back pain

Vomiting

Aspartate aminotransferase increased

Bile duct obstruction

Pain in extremity

Muscle spasms

Oropharyngeal pain

Blood alkaline phosphatase increased

Dizziness

Rash

Dyspepsia

Hepatic enzyme increased

Sinusitis

Upper respiratory tract infection

Chills

Flank pain

Meniscus injury

Alanine aminotransferase increased

Type 2 diabetes mellitus

Urticaria

Viral infection

Cholangitis sclerosing

Sepsis

Abdominal pain lower

Pouchitis

Hyperbilirubinaemia

Chest pain

Gamma-glutamyltransferase increased

Decreased appetite

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)

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