A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor-blinded-Study of Risankizumab Compared to Deucravacitinib for the Treatment of Adult Subjects with Moderate Plaque Psoriasis who are Candidates for Systemic Therapy
This study is for adults in the UK who have plaque psoriasis that is moderate and severe enough to need strong treatment. It's comparing two medicines: risankizumab and deucravacitinib. The main goal is to see how much each medicine improves skin by clearing up psoriasis after 16 weeks. Researchers will also look at how many people achieve completely clear or nearly clear skin. A special part of the study will follow people who start on deucravacitinib but don't see enough improvement by 16 weeks. These individuals will switch to risankizumab to see if it helps them achieve clearer skin by 52 weeks. It's a study designed to understand the treatments better in real-world use.
At a glance
What is this study about?
This study, called a 'Phase 4' study, is looking at how effective two existing medicines, risankizumab and deucravacitinib, are for adults with moderate plaque psoriasis. Plaque psoriasis is a common skin condition that causes red, scaly patches on the skin. Moderate psoriasis means it affects a noticeable area of the body and can impact daily life.
The study aims to compare these two medicines to see which one works better at clearing up the skin over time. Researchers will be especially interested in seeing how many people achieve clear or nearly clear skin after 16 weeks of treatment. It’s also set up to see what happens if one medicine doesn't work well enough for someone. If participants start on deucravacitinib and their skin hasn't improved by a certain amount after 16 weeks, they will be given the option to switch to risankizumab. The study will then check if this change of medicine helps them get better results by 52 weeks.
Because this is a Phase 4 study, it means both medicines are already approved and available for use. This type of study helps doctors and patients understand more about how these treatments work in a broader group of people and in different situations, like when someone needs to switch treatments.
Key takeaways
- Compares two existing psoriasis medicines: risankizumab and deucravacitinib.
- For adults with moderate plaque psoriasis needing strong treatment.
- Aims to see which medicine clears skin better after 16 weeks.
- Allows switching medicine if the first one doesn't work well enough.
- Close medical supervision throughout the study.
- Helps understand treatments for psoriasis in real-world scenarios.
Who may be eligible?
To be part of this study, you need to be an adult, 18 years or older, with plaque psoriasis. Your psoriasis should be considered 'moderate', meaning it's significant enough that your doctor might suggest a stronger treatment than just creams or ointments.
Both men and women can take part in this study. The researchers are looking for a diverse group of people to help them understand how these medicines work across different individuals.
There will be other specific health checks and rules to make sure the study is safe and that results are clear. Your doctor will be able to tell you if you meet all the requirements for this particular study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with plaque psoriasis?
- Is your psoriasis considered 'moderate' by your doctor, needing more than just creams?
- Are you able to attend regular clinic appointments for treatment and check-ups?
What does participation involve?
If you decide to join this study, you would be randomly assigned to receive either risankizumab or deucravacitinib. This means a computer decides which medicine you get, like flipping a coin for fairness. You would continue taking your assigned medicine and have regular visits to the clinic for check-ups and assessments. These visits would involve doctors looking at your skin, asking about your symptoms, and possibly taking blood samples.
For some participants, if deucravacitinib isn't clearing their psoriasis enough after 16 weeks, they might have the option to switch to risankizumab. The study involves taking the medicine for a number of weeks, up to 52 weeks in total, with follow-up appointments throughout this period. The doctors doing the skin assessments won't know which medicine you're taking, which helps keep the results unbiased.
Potential risks and benefits
Locations (7)
- —UnverifiedHungary
- —UnverifiedGermany
- —UnverifiedGreece
- —UnverifiedItaly
- —UnverifiedNetherlands
- —UnverifiedBelgium
- —UnverifiedSpain
Common questions
What is plaque psoriasis?
Plaque psoriasis is a long-lasting skin condition that causes red, scaly patches on the skin, often on elbows, knees, scalp, and lower back.
What does a 'Phase 4' study mean?
A Phase 4 study means the medicines being tested are already approved and available. This type of study helps us learn more about them in real-world settings and over longer periods.
Will I know which medicine I'm getting?
You will be told which medicine you are receiving, but the doctors assessing your skin won't know, to ensure fair results.
What if the medicine doesn't work for me?
If you start on deucravacitinib and it's not working well enough after 16 weeks, you may have the option to switch to risankizumab within the study.
How long does the study last?
The study involves taking medicine and having check-ups for up to 52 weeks, with regular visits during this time.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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