A Phase 4 Mechanistic Longitudinal Study to Evaluate the Impact of EARLY Risankizumab Treatment on TRM Cell Levels in Moderate-to-Severe Psoriasis
This study, called a Phase 4 trial, is investigating how a medicine called Skyrizi (risankizumab) works in people with moderate to severe psoriasis. The main goal is to understand how early treatment with Skyrizi affects specific skin cells, called TRM cells, compared to starting treatment later. These cells are thought to play a role in psoriasis. Researchers will measure changes in these cells after 16 weeks. They will also look at how clear participants' skin becomes over a year, specifically checking for complete or near-complete clearance. The study will monitor other body markers related to inflammation and heart health, and importantly, will track any side effects to understand the safety of the treatment. This helps doctors understand the best way to use Skyrizi for psoriasis.
At a glance
What is this study about?
This research study is looking at a medicine called Skyrizi (risankizumab) for people who have moderate to severe psoriasis. Psoriasis is a skin condition that causes red, scaly patches. Skyrizi is already approved for use, and this study, known as a Phase 4 trial, aims to understand more about how it works and how best to use it in real-world situations.
The main aim of this study is to compare what happens when people start Skyrizi treatment early versus when they start it a bit later. Specifically, researchers are interested in certain cells in the skin called 'TRM cells'. These cells are thought to be important in psoriasis, and the study wants to see if starting Skyrizi sooner helps to reduce the number of these cells more effectively than a later start. They will measure these changes over 16 weeks.
Beyond just looking at these specific cells, the study will also track how well the treatment clears up the skin, looking at how many people achieve completely clear skin or nearly clear skin at different points over a year. They'll also check other signs in the body related to inflammation and heart health, and carefully record any side effects to make sure the treatment is safe. All this information will help doctors understand the best way to use Skyrizi to help people with psoriasis.
Key takeaways
- This study investigates an approved psoriasis treatment called Skyrizi.
- It compares starting treatment early versus a bit later.
- Researchers are focusing on specific skin cells and how clear skin becomes.
- The study also monitors safety and other health markers.
- It's for adults aged 18 and over with moderate to severe psoriasis.
- Participation lasts about 14 months with regular check-ups.
Who may be eligible?
To take part in this study, you would need to be an adult, aged 18 years or older, as there is no upper age limit. The study is open to both men and women.
Like all clinical trials, there will be specific health criteria that you'd need to meet to make sure the study is right for you and that the results are clear. For example, you would need to have been diagnosed with moderate to severe psoriasis.
It's important to discuss your full medical history with the study doctor, as they will be able to tell you if you meet all the necessary requirements to be considered for participation.
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?
- Do you have moderate to severe psoriasis?
- Are you able to attend regular appointments for over a year?
- Are you comfortable with blood tests and small skin biopsies?
What does participation involve?
If you decide to take part in this study, you would receive Skyrizi, which is given as an injection, at the recommended doses. The study is designed to compare two treatment groups: one starting treatment early and another starting treatment later. You would attend several visits over a period of about 60 weeks (around 14 months) where doctors will monitor your skin, take samples (like small skin biopsies from affected and unaffected skin), and collect blood samples to check for the specific cells and other markers being studied.
During these visits, you'll also have assessments to see how much your psoriasis has improved and to check for any side effects. The study aims to follow participants for a significant period to see the long-term effects of the treatment and to compare the outcomes between the early and late treatment groups. You would be given detailed information about the schedule of visits and what each visit involves.
Potential risks and benefits
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Common questions
What is the main goal of this study?
The main goal is to see if starting Skyrizi treatment earlier helps reduce certain skin cells (TRM cells) in psoriasis more effectively than starting later.
Is Skyrizi a new medicine?
No, Skyrizi is an approved medicine for psoriasis. This study is looking at how best to use it.
How long does the study last if I join?
The study involves regular visits over approximately 60 weeks, which is about 14 months.
Who can take part in this study?
Adults aged 18 and over, both men and women, with moderate to severe psoriasis may be eligible.
Will I get the actual medicine or a dummy treatment?
Everyone in this study will receive Skyrizi at the recommended doses, but at different times (early vs. late treatment group).
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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