ELMWOOD
Evaluating the Safety And Efficacy of Elafibranor in Adult Participants with PSC
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About Elafibranor
ELMWOOD is investigating a drug called 'Elafibranor'. It is an investigational drug that is taken by mouth. It activates specific receptors (PPARα/δ) in the human body, particularly in the liver1,2. Activation of these receptors is thought to have different effects, including reduced inflammation and improvement of bile acid composition and flow3.
FAQs
| Trial Name | ELMWOOD
A Phase II, Multicentre, Double-Blind*, Randomised, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis. (ELMWOOD) |
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| ClinicalTrials.gov Identifier | NCT05627362 | |
| Phase | Phase 2 trial | |
| Intervention | During Double-Blind* Period: Once a day elafibranor 80 mg or 120 mg or placebo (dummy drug), taken by mouth
Open-Label Extension** Period: Elafibranor 120 mg once daily taken by mouth |
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| Recruiting now? | Yes (recruiting soon in the UK) | |
| Participating Centres | (Around 60 sites worldwide) Please refer to current list on clinicaltrials.gov. and the see PSC Support map.
United Kingdom sites: (~60 sites worldwide to be activated) Please refer to current list on clinicaltrials.gov. United Kingdom sites:
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| Contact | clinical.trials@ipsen.com | |
| Liver disease diagnosis | Confirmed diagnosis of large duct PSC based on clinical guidelines | |
| Age | 18 years to 75 years | |
| Females: can I be pregnant? | No | |
| Is IBD (inflammatory bowel disease) allowed? | Yes, but meeting certain inclusion criteria. | |
| Is there an ALP (alkaline phosphatase) requirement? | Yes, ALP ≥1.5x times the upper limit of the normal range during screening (with variability ≤30% based on two values measured during screening). | |
| Can I take UDCA (Urso)? | Yes | |
| Can I take biologics? | Yes | |
| Can I take part if I have a stent? | No percutaneous drain or bile duct stent | |
| Are recent acute cholangitis (ie bacterial cholangitis) attacks allowed? | There should be no history of bacterial cholangitis within 60 days prior to the screening period. | |
| Can I take part if I have had a liver transplant? | No | |
| Is cirrhosis allowed? | Yes, but only those patients with cirrhosis Child-Pugh A score | |
| Are travel expenses covered? | Yes (with approval conditions) | |
| Procedures and tests include: | Blood tests, electrocardiogram, ultrasound scans, Transient Elastography (FibroScan®), questionnaires etc. | |
| How many study visits will there be? How long will each study visit be? | At least 12 study visits, with variable visit duration depending which assessments are being completed on each day | |
| Duration of study |
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| Basic design of study | Randomised, double-blind*, multicentre, parallel group study with open label extension* | |
| How is this intervention thought to work and what is it thought to do? | ELMWOOD is investigating a drug called 'Elafibranor'. It is an investigational drug that is taken by mouth. It activates specific receptors (PPARα/δ) in the human body, particularly in the liver1,2. Activation of these receptors is thought to have different effects, including reduced inflammation and improvement of bile acid composition and flow3. | |
| Study website | clinicaltrials.gov ELMWOOD | |
| Link to Sponsor | Ipsen |