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PPAR agonist

Elafibranor for Primary Sclerosing Cholangitis (ELMWOOD Trial)

Verified Trial
Phase 2
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 diagnosis of Primary sclerosing cholangitis (PSC) as demonstrated by the presence of the following, and in the absence of apparent causes of secondary sclerosing cholangitis: i) Historical evidence of an elevated Alkaline phosphatase (ALP) > Upper Limit Normal (ULN) since at least 6 months prior to SV1. ii) Cholangiogram (e.g. magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), percutaneous transhepatic cholangiography (PTC) with features compatible with large duct PSC.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, 0.5 hour (h), 1h, between 1.5h and 2h, 4h, and 6h after dosing at week 4
Awards & highlights

ELMWOOD Trial Summary

This trial will evaluate a drug to treat a rare liver disorder, Primary Sclerosing Cholangitis, which can lead to damage & destruction of bile ducts & further liver damage. It will compare the drug to a dummy & study its safety & effects on blood tests.

Who is the study for?
Adults with Primary Sclerosing Cholangitis (PSC) can join this trial. They must have stable Inflammatory Bowel Disease if present, no recent severe liver issues or cancer, and be on a steady dose of certain medications like ursodeoxycholic acid. Participants need to use approved contraception methods and not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial is testing Elafibranor at two different doses (80 mg and 120 mg) against placebos matched for each dose. The goal is to see how safe Elafibranor is and how well it works in treating PSC by comparing its effects on liver function tests and other disease-related measures.See study design
What are the potential side effects?
While the specific side effects of Elafibranor are not listed here, common side effects may include digestive issues, fatigue, itching (pruritus), abnormal blood tests reflecting liver function changes, muscle pain or weakness.

ELMWOOD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with PSC and have had high ALP levels for over 6 months.

ELMWOOD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 0.5 hour (h), 1h, between 1.5h and 2h, 4h, and 6h after dosing at week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 0.5 hour (h), 1h, between 1.5h and 2h, 4h, and 6h after dosing at week 4 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 Clinically Significant Changes in Electrocardiogram (ECG) Readings
Percentage of Participants With Clinically Significant Changes in Physical Examination Findings
Percentage of Participants With Clinically Significant Changes in Vital Signs
+2 more
Secondary outcome measures
Absolute Change from Baseline in ALP
Change From Baseline in Alanine Transaminase (ALT),Aspartate Transaminase (AST), Gamma-glutamyl transferase (GGT), 5' Nucleotidase and Fractionated ALP Levels at Week 12
Change From Baseline in Albumin Levels at Week 12
+15 more

ELMWOOD Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Open-Label Extension Period: Elafibranor 120 mgExperimental Treatment1 Intervention
Participant will receive one tablet per day (elafibranor 120 mg) over the 96 weeks in Open-Label extension period.
Group II: Double-Blind Period: Elafibranor 80 mgExperimental Treatment2 Interventions
Participant will receive two tablets per day (one tablet of elafibranor 80 mg + 1 tablet of placebo matching the 120 mg sized tablet) over the 12 weeks in Double-blind period.
Group III: Double-Blind Period: Elafibranor 120 mgExperimental Treatment2 Interventions
Participant will receive 2 tablets per day (one tablet of elafibranor 120 mg + 1 tablet of placebo matching the 80 mg sized tablet) over the 12 weeks in Double-blind period.
Group IV: Double-Blind Period: PlaceboPlacebo Group1 Intervention
Participant will receive 2 placebo tablets per day (one matching the 80 mg sized tablet + one matching the 120 mg sized tablet) over the 12 weeks in Double-blind period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elafibranor 80 mg
2017
Completed Phase 2
~50
Elafibranor 120 mg
2017
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

IpsenLead Sponsor
345 Previous Clinical Trials
73,168 Total Patients Enrolled
Ipsen Medical, DirectorStudy DirectorIpsen
5 Previous Clinical Trials
838 Total Patients Enrolled

Media Library

Elafibranor (PPAR agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05627362 — Phase 2
Primary Sclerosing Cholangitis Research Study Groups: Double-Blind Period: Elafibranor 80 mg, Double-Blind Period: Elafibranor 120 mg, Double-Blind Period: Placebo, Open-Label Extension Period: Elafibranor 120 mg
Primary Sclerosing Cholangitis Clinical Trial 2023: Elafibranor Highlights & Side Effects. Trial Name: NCT05627362 — Phase 2
Elafibranor (PPAR agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05627362 — Phase 2

Frequently Asked Questions

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

Does the protocol for this experiment accept participants over 60 years of age?

"This medical experiment is hoping to recruit individuals aged 18 and higher but below 75 years old."

Answered by AI

Are there still openings for individuals to join this clinical experiment?

"The information hosted on clinicaltrials.gov reveals that patients are being sought out for this trial, which was first published in January 27th 2022 and edited the most recent time at February 13th 2023."

Answered by AI

How many individuals are engaging in this experiment?

"With 60 patients meeting the qualifications, Ipsen is set to commence this trial at Peak Gastroenterology Associates in Colorado Springs and Mercy Medical Center in Baltimore."

Answered by AI

In how many healthcare facilities is this experiment being conducted?

"Peak Gastroenterology Associates in Colorado Springs, Mercy Medical Center in Baltimore, and the American Research Corporation at The Texas Liver Institute in San Antonio are all accepting patients for this trial. In addition to these 3 sites, 4 other medical centres are involved."

Answered by AI

Has the FDA released its endorsement of Elafibranor 120 mg during Double-Blind Periods?

"Taking into account the Phase 2 status of this medication, our team has given Double-Blind Period: Elafibranor 120 mg a safety score of 2. While there is some evidence to suggest its safety, efficacy still needs to be evaluated."

Answered by AI

What is the eligibility criteria for participating in this clinical experimentation?

"This investigation is open to 60 individuals aged 18-75 diagnosed with primary sclerosing cholangitis. Eligible participants must fulfill the following criteria: Total bilirubin ≤2x ULN at Screening Visit 1 (SV1), elevated Alkaline phosphatase (ALP) > Upper Limit Normal (ULN) for a 6 month period prior to SV1, ALP ≥1.5x ULN during screening, ursodeoxycholic acid dosage of ≤23 mg/kg/day taken for no less than 6 months prior to screening and expected through 12 weeks DBP; IBD remission"

Answered by AI

Who else is applying?

What site did they apply to?
Mercy Medical Center
Southwest Gastroenterology Associates, PC (SWGA)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
2023. "A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05627362.
All > Tandem
~19 spots leftby Dec 2024
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