← Back to Search

PPAR agonist

Elafibranor for Primary Biliary Cholangitis (ELSPIRE Trial)

Phase 3

Recruiting

Research Sponsored by Ipsen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with a historical diagnosis of PBC as demonstrated by the presence of ≥2 of the following three historical diagnostic criteria: History of elevated ALP levels for ≥6 months prior to the first screening visit (SV1), Positive Antimitochondrial antibody (AMA) titres (≥1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay) or positive PBC-specific antinuclear antibodies, Liver biopsy consistent with PBC

Be older than 18 years old

Must not have

Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain

Alpha-foetoprotein (AFP) >20 ng/mL with 4-phase liver computed tomography (CT) or magnetic resonance imaging (MRI) scans suggesting presence of liver cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 4, week 12, week 24, week 36 and week 52

Awards & highlights

Pivotal Trial

Summary

This trial will study the effectiveness of a new medication called elafibranor in treating primary biliary cholangitis (PBC) in patients who have not responded well to the standard medication,

Who is the study for?

Adults over 18 with Primary Biliary Cholangitis (PBC) who haven't responded well to or can't tolerate Ursodeoxycholic Acid. They must have had high ALP levels for at least 6 months, positive antibodies indicating PBC, and a liver biopsy consistent with PBC. Men in the trial must use contraception during and for 30 days after the study.

What is being tested?

The trial is testing Elafibranor against a placebo in patients with PBC. It aims to see if Elafibranor lowers ALP levels better than a dummy treatment. Participants will be chosen randomly to receive either Elafibranor or placebo in a 2:1 ratio and monitored through blood tests, physical exams, ECGs, ultrasounds, Fibroscans®, and questionnaires.

What are the potential side effects?

Potential side effects of Elafibranor are not detailed here but may include reactions similar to other medications affecting liver function such as gastrointestinal discomfort, fatigue, itching (pruritus), headache or skin reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with PBC based on elevated ALP, positive AMA or specific liver biopsy results.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am mentally capable of understanding and following the study's requirements.

Select...

My AFP levels are above 20 ng/mL, and scans indicate I might have liver cancer.

Select...

I have previously taken elafibranor.

Select...

I am not pregnant, have not tested positive for pregnancy, and am not breastfeeding.

Select...

I have a serious kidney condition.

Select...

I have or had other liver diseases.

Select...

I have had a liver transplant.

Select...

I have a history of serious liver problems.

Select...

My kidney function is reduced with an eGFR below 45.

Select...

I haven't had cancer in the last 2 years, except for certain skin cancers or cervical cancer that didn't spread.

Select...

I have had liver cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 4, week 12, week 24, week 36 and week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 4, week 12, week 24, week 36 and week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 4, week 12, week 24, week 36 and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change from baseline in 5-D itch score

Change from baseline in PBC Worst Itch Numeric Rating Scale (NRS) score

Change from baseline in PBC-40 Quality of Life (QoL) scores

+10 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Elafibranor 80 mgExperimental Treatment1 Intervention

Participants will take 1 tablet of elafibranor 80 mg per day orally before breakfast with a glass of water at approximately the same time each morning.

Group II: PlaceboPlacebo Group1 Intervention

Participants will take 1 placebo tablet per day orally before breakfast with a glass of water at approximately the same time each morning.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Elafibranor

2022

Completed Phase 1

~110

0 / 12Eligibility criteria met