Understanding the effect of medication on the body's inflammatory response may lead to new treatments for autoimmune conditions, including psoriasis.
Plaque psoriasis is an autoimmune condition characterised by dry, itchy and scaly skin patches (plaques). It can be extremely uncomfortable to live with.
The investigational drug for this study is JNJ-77242113 and is given as an oral tablet. JNJ-77242113 proved substantial efficacy in clearing plaque psoriasis in a previous study.
The purpose of this research project is to measure how safe and effective this medication is in treating participants with plaque psoriasis. This is a three-year study, which aims to understand the medication’s inhibiting effect on the body’s inflammatory response. The outcome of this project could support new treatments to increase quality of life in people with plaque psoriasis.
Anticipated date that enrolment will close: Late 2024
Who can take part
You may be able to participate in this study if you:
- are at least 18 years of age, and have been diagnosed with plaque psoriasis (with or without psoriatic arthritis) for at least 26 weeks
- are able to comply for 12 weeks without taking systemic psoriasis biologic drugs, and at least 4 weeks without phototherapy
- are willing and able to adhere to attend monthly study visits at the Royal Melbourne Hospital over the course of the study
You may not be eligible if you:
- have a non-plaque form of psoriasis (for example, erythrodermic, guttate, pustular, drug-induced)
- have had major surgery within 8 weeks before screening or incomplete recovery from previous surgery
- have a history of drug or alcohol abuse within one year before screening
- have had suicidal ideation within 26 weeks prior to screening
- attend the RMH for monthly study visits over one year, and then less frequently over the subsequent two years
- most study visits should take about one hour, however your first and second visit will be longer
- provide blood and urine samples
- maintain a daily symptom diary for 24 weeks
- optional photography sub-study and optional biopsy sub-study
- undergo ECG, physical examinations, questionnaires, and x-ray
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.