Clinical Studies Actively Recruiting Patients

Our two lead clinical studies are recruiting patients. If you have pruritus due to prurigo nodularis (PN) or chronic cough due to idiopathic pulmonary fibrosis (IPF) you may qualify to participate.

Pruritus due to PN

The PRISM trial is a medical research study of an investigational medication for people who have chronic, severely itchy bumps on their skin (also known as Prurigo Nodularis). Actively recruiting in the United States, Germany, Poland, Austria, and France.

See if you qualify.

Chronic Cough due to IPF

The CANAL trial is a clinical research study looking at how an investigational study drug works on cough in people with idiopathic pulmonary fibrosis (IPF). Actively recruiting in the United Kingdom.

Learn more. 

A Pipeline in a Product: Haduvio™

Trevi is developing the investigational therapy Haduvio™ (nalbuphine ER) in a range of indications for which patients have few treatment options. With its dual mechanism of action, acting as both an antagonist (blocker) to the mu opioid receptor and as an agonist (activator) to the kappa opioid receptor, Haduvio has the potential to significantly improve the quality of life of patients suffering from serious neurologically mediated conditions by targeting the central and peripheral nervous systems.

We are conducting a global clinical development program for Haduvio™.

 
Pruritus Associated with Prurigo Nodularis (PN)

Prurigo Nodularis is a chronic, intensely pruritic dermatological condition characterized by the presence of pruriginous lesions such as papules, nodules or plaques, which may be associated with excoriations and ulcerations.

In September 2018, we initiated our pivotal Phase 2b/3 PRISM (Pruritus Relief thru Itch-Scratch Modulation) clinical trial evaluating the safety and efficacy of Haduvio in patients with severe pruritus associated with PN.

The PRISM trial is a randomized, double-blind, placebo-controlled, parallel, two-arm, 14-week treatment study that is evaluating the safety and anti-pruritic efficacy of Haduvio 162 mg tablets in 360 patients at more than 60 sites in the United States and Europe.

Interested in the PRISM trial? Click:  https://www.theprismstudy.com to take the short Pre-Qualifying questionnaire.

We are now enrolling patients in the U.S. (NCT number: NCT03497975) and in the EU.

Chronic Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)

IPF is a rare, chronic, progressive lung disease, characterized by scarring and thickening of lung tissue; most patients diagnosed with IPF suffer from a dry, non-productive chronic cough that interrupts their daily living and significantly contributes to poor quality of life.

We are conducting a Phase 2 clinical trial of Haduvio for chronic cough in patients with IPF. The Phase 2 trial is a randomized, double-blind, placebo controlled, two-treatment, two-period, crossover study designed to evaluate the efficacy, safety, tolerability and dosing of Haduvio for chronic cough in up to 56 patients with IPF in the United Kingdom.

The CANAL Study is currently enrolling patients in the UK. Click here to learn more.

Pruritus in Chronic Liver Disease

A common complication of chronic cholestatic liver diseases such as primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC); patients develop severe whole-body itch, an intense, intractable, debilitating condition that significantly disrupts patients’ daily activities and sleep, and consequently impairs their quality of life.

A Phase 1b open label study is complete to determine the safety and pharmacokinetics of Haduvio in patients with moderate to severe chronic liver disease.

Uremic Pruritus (UP)

A common, disruptive pruritic condition principally experienced by an estimated 70% of patients undergoing hemodialysis; causes significant impairment in patients’ quality of life and increased mortality.

We are not actively developing Haduvio for uremic pruritus at this time based on our evaluation of the market dynamics, but may consider resuming development in the future.

Levodopa-induced Dyskinesia (LID) in Patients with Parkinson’s Disease

Involuntary movements that negatively impact patients’ lives; it is estimated that motor complications resulting from levodopa therapy affect about 400,000 patients with Parkinson’s disease in the United States, with dyskinesia occurring in approximately 150,000 patients.

Subject to discussions with the FDA and the submission of an IND for this indication, we intend to initiate a Phase 2 trial of Haduvio to evaluate the effect of Haduvio on LID in patients with Parkinson’s disease.

 

scientific and clinical
posters & publications

The Role of Kappa- and Mu- Opioid Receptors in Pruritus

as presented at Maui Derm for Dermatologists 2021

Prevalence of prurigo nodularis in the United States of America: A retrospective database analysis

Ständer et al., The American Academy of Dermatology (JAAD) International (2020)

Prevalence of Prurigo Nodularis in Poland

Reich and Ryczek, Acta Dermato Venereologica (2020)

Nalbuphine attenuates itch in the substance P-induced mouse model

as presented at 7th World Congress on Itch (2013).

contact

Trevi Therapeutics

195 Church Street, 14th Floor
New Haven, CT 06510
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(203) 304-2499
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