Clinical Trial open

Actively seeking patients with prurigo nodularis 

The Prism study

Our Pruritus Relief through Itch-Scratch Modulation (PRISM) study is exploring an investigational oral therapy for subjects suffering with severe itch due to prurigo nodularis.

Target Enrollment

The Phase 2b/3 PRISM Study will enroll approximately 360 patients with severe itch due to prurigo nodularis (PN or Nodular Prurigo). 

Double-Blind Study

The first two weeks of the study consist of a blinded titration period which is followed by a 14-week treatment period with an immediate rollover into the follow-on long term open label safety study. 

Open Label Extension

The open label safety study is for an additional 38 weeks where all patients receive active drug. 

Inclusion and exclusion criteria

Learn more about the PRISM Study’s key inclusion and exclusion criteria to see if you have patients that qualify.

Key Inclusion Criteria

  • Patients diagnosed with generalized PN as defined as the presence of ≥ 10 pruriginous nodules on at least 2 distinct anatomical areas
  • Patient considers their itch to be ‘severe’ for greater than 6 weeks
  • Age ≥ 18 years (no upper limit)
  • No other active skin problems except the PN (for example no active eczema or atopic dermatitis lesions)

Key Exclusion Criteria

  • Concurrent enrollment in ongoing clinical trial or anticipate enrollment in a concurrent clinical trial – Patients participating in a COVID-19 study are allowed as long as they are in the follow up period (post vaccine)
  • Unwilling to stop any therapies they are currently using to manage the PN including antihistamines (topical and systemic)

Prurigo Nodularis In terms of Numbers

1,2,3,4

US Prevalence

5

Ex-US Prevalence

1 Huang AH JID 2020 2 Stander S JAAD 2020 3 Iking A JEADV 2013 4 Pereira M JEADV 2018 5Prurigo Nodularis –
Market Insights, Epidemiology and Market Forecast.

Resources

Click on your corresponding country next to the resource you would like to download.

Waiting Room Poster

Waiting Room Poster

Patient Education Brochure

Patient Education PDF

These documents are approved by the applicable IRB/IEC for use ONLY with patients in the country specified: English: USA,  Polish: Poland, German: Germany and Austria, French: France.

Currently there are no approved therapies for prurigo nodularis, leaving patients and providers, like yourselves, with a huge unmet need.

Frequently asked questions

How does Nalbuphine ER Work?

Nalbuphine ER has a dual mechanism of action, acting as both a KOR (kappa opioid receptor) agonist and a MOR (mu opioid receptor) antagonist.

It is an opioid, do I need to worry about it like other pain meds?

Nalbuphine belongs to a sub-class of opioids referred to as mixed agonist-antagonists.  These substances were specifically developed to combat the abuse potential of pure mu agonists that are used in pain relief.  Nalbuphine is currently approved in an injectable form. This injectable form has a long history of safe and effective use in acute settings such as labor and delivery.  It was approved for marketing in the United States in 1979 and remains the only narcotic analgesic marketed in the U.S. that is not scheduled under the Controlled Substances Act. The DEA reviews this status every two years and the drug has remained unscheduled.1 The scheduling for nalbuphine ER will be determined during the review of the NDA application.

1DEA Diversion Control Division

How could nalbuphine work in itch?

The kappa opioid receptor (KOR) and mu opioid receptor (MOR) are recognized as key mediators of itch signaling. Prurigo Nodularis (PN) is believed to be a neuro-inflammatory condition involving central and peripheral nerves, along with inflammatory pathways. 1,2 As a dual acting KOR agonist/MOR antagonist, nalbuphine’s mechanism-of-action has been shown to reduce itch in a range of settings through various neuronal (i.e. downregulating itch signaling at peripheral and central nerve synapses) and anti-inflammatory (i.e. reduces IL-31, Substance P) mechanisms. 3,4,5,6 These neuronal and anti-inflammatory properties of nalbuphine are believed to be effective in suppressing the itch-scratch cycle in PN.

1Erickson S et al. AAAI 2021 2Dhand A Aminoff M Brain 2014 3Metze et al. JAAD 1999 4Phan NQ et al. JAAD 2010 5Inan et al. Eur J Pharmacol 2019 6Umeuchi, et al. Eur J Pharmacol 2003

What support is provided to patients to help them safely get to their study visits?

Our team is dedicated to getting your patients to the site as safely as possible. We recognize that some patients might not have easy access to safe and affordable transportation, that is why we offer support to assist with transportation expenses.  

Study Site Locations

Click on a marker to find a study site near you.

Click on a marker to find a study site near you.

Get in Touch

Click the ‘CONTACT’ button to send an email to our team to learn more about the PRISM Study.

A member of our team will get back to you within 48-72 hours.

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