This study aims to assess efficacy and safety of JNJ-77242113 compared to placebo and ustekinumab in people with moderate to severe Plaque Psoriasis.
The investigational study drug JNJ-77242113, and the purpose of this study is to help researchers better understand the effects of the study drug compared to ustekinumab and placebo.
JNJ-77242113 is a tablet medication that blocks the receptor for an inflammatory protein made by the immune cells (cells that help the body fight infections and other diseases) called interleukin-23.
The study drug is being compared to ustekinumab, which is an injection medication. It is also being compared to placebo. The placebos look just like JNJ-77242113 or ustekinumab and will be given in the same form (that is, tablet and injection respectively) but the placebo will not have any medicine in it.
To find out which treatment is better for treating a condition, participants are put into groups by chance (random) and each group is given a different treatment.
Anticipated date enrolment will close: 05 November 2025
Who can take part
You may be able to participate if you:
- are aged 18 years or older at the screening visit
- have a diagnosis of moderate to severe plaque psoriasis for at least 26 weeks prior to the first administration of study drug
You may not be eligible if you:
- are on oncurrent treatment with other plaque psoriasis medications (tablet or injection)
- are pregnant, planning to become pregnant, or breastfeeding during the study
What's involved
- The duration of the study is 113 weeks (just over 2 years)
- Participants will need to be able to attend the RMH apporximately 20 times over the trial period
- During the first 28 weeks you will take one tablet of study drug once daily (either JNJ-77242113 or oral placebo) and receive three injections (either ustekinumab or injectable placebo). After Week 28, you will take one tablet of JNJ-77242113 daily
- X-ray/CT scan
- Tuberculosis (TB) evaluation and TB test
- Medical history, physical examination, vital signs and weight
- Provide blood and urine samples
- ECG test
- Tablet questionnaires on plaque psoriasis
- Home e-diary
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.