The Prurigo Nodularis trial aims to assess the safety and effectiveness of a treatment to assist in reducing symptoms for people living with this condition

Currently recruiting
HREC ethics approval number 2024.084

About this study

Prurigo nodularis is a chronic skin condition characterized by very itchy, raised bumps on the skin. The investigational drug for this study is Rocatinlimab (AMG 451), which is given as an injection under the skin. Rocatinlimab is designed to block a protein called OX40 that contributes to inflammation.  The purpose of this research project is to evaluate the safety and effectiveness of Rocatinlimab in treating participants with prurigo nodularis. The findings could lead to new treatment options to improve the quality of life for people suffering from this condition.

Anticipated enrolment close date: June 2025

Contact us to find out more about this research study, quoting reference number 2023.084

Who can take part

This trial might be right for you if you:

  • Are aged 18 years and over
  • Have a diagnosis of Prorigo Nodularis
  • Experience intense itching for more than 6 weeks and have multiple raised bumps on the skin.
  • At least 20 Prurigo Nodularis bumps located on both arms, both legs, or the trunk.
  • Have not responded well to medium or stronger topical treatments for Prurigo Nodularis

Please note that other eligibility criteria also apply.

What's involved

Participation includes:

  • Attending the RMH about 17 times over the 12-month trial period. Most study visits should take about one hour, however your first and second visit will be longer.
  • Medical history, physical examination, height, and weight
  • Provide blood and urine samples
  • Undergo ECG test
Person handling test tubes for research

Ethics

All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.

This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.