Plaque psoriasis is an autoimmune condition characterised by dry, itchy and scaly skin patches. This trial investigates whether people with plaque psoriasis may be able to take an oral treatment to improve the condition.
The investigational treatment in this study is JNJ-77242113 and is given as an oral tablet.
In a previous study, this tablet, JNJ-77242113, substantially cleared plaque psoriasis in participants.
The purpose of this research project is to measure how safe and effective this medication is in treating participants with plaque psoriasis. It 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: March 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 trial
- are up-to-date on all age-appropriate vaccinations
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 1 year before screening
- have had suicidal ideation within 26 weeks before 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
- undergo genotyping (unless documented in your medical history)
- maintain a daily symptom diary for 16 weeks
- undertake photography sub-study and biopsy sub-study (optional)
- undertake 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.