A Phase 3b, Randomized, Double-blind, Parallel Group, Multicenter Study to Evaluate Further Therapeutic Strategies with Guselkumab in Patients with Moderate-to-Severe Plaque-Type Psoriasis
This research study is for adults in the UK who have moderate to severe plaque-type psoriasis. The aim is to find even better ways to use an existing medicine called guselkumab. Participants will be split into different groups, and some will receive guselkumab, while others might receive a dummy treatment (placebo) or guselkumab alongside other strategies. This is a "double-blind" study, meaning neither you nor your doctor will know which treatment you are getting, to keep the results fair. The main goal is to see how many people achieve nearly clear skin after 68 weeks. We hope to learn which treatment plans are most effective and safe for improving the lives of people with psoriasis.
At a glance
What is this study about?
Imagine you have moderate to severe plaque-type psoriasis, a condition that causes red, scaly patches on your skin. Medicines like guselkumab are already used to help manage this. However, doctors are always looking for ways to make treatments even better and more effective for people.
This study is a bit like trying out new recipes with an ingredient you already know works well. We're testing different ways to use guselkumab, perhaps by combining it with other approaches, to see if we can achieve even better results in clearing up psoriasis. Understanding the best ways to use existing medicines can lead to improved care for many people in the future.
The study is called a "Phase 3b" study, which means the main safety and effectiveness of guselkumab have already been checked. Now, we're looking to refine how it's used in real-world situations, comparing different treatment strategies to find the most successful ones for you. This kind of research is really important because it helps doctors make informed decisions about the best care for their patients.
Key takeaways
- This study explores better ways to use an existing psoriasis medicine.
- It's for adults with moderate to severe plaque psoriasis.
- You might receive guselkumab or a dummy treatment (placebo).
- Regular clinic visits and assessments will be part of the study.
- The study aims to improve future psoriasis treatments.
- You can stop participating at any time.
Who may be eligible?
This study is looking for adult volunteers, aged 18 years or older, who have moderate to severe plaque-type psoriasis. This means your psoriasis is more than just a few small patches and is likely affecting your daily life.
Both men and women can take part. There will be other health checks to make sure the study treatments are safe for you. For example, your doctor will need to check your general health, past medical conditions, and any other medicines you are taking, to see if you are suitable.
To see if you are a good fit for this study, a doctor will review your medical history and might ask you some questions about your psoriasis. They will explain all the details if you are interested in joining.
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 plaque-type psoriasis?
- Are you able to attend regular clinic appointments?
- Are you willing to potentially receive a placebo?
- Are you open to having your health monitored closely?
What does participation involve?
If you decide to join this study, you will be part of it for a specific period, possibly up to 68 weeks. During this time, you will have regular visits to the clinic. At these visits, doctors and nurses will check your health, assess your psoriasis, and ask you about how you are feeling. You will be given either guselkumab (the study medicine) or a placebo (a dummy injection that looks like the real medicine but contains no active drug). You and your study doctor will not know which one you are receiving.
Both guselkumab and the placebo will be given as an injection using a pre-filled syringe. You will be shown how to do this safely, or it might be given to you by a nurse at the clinic. There will be regular follow-up appointments to monitor your progress and make sure you are tolerating the treatment well. You may also need to provide blood samples for tests at some of these visits. Your commitment to these visits and assessments is important for the study's success.
Potential risks and benefits
Locations (1)
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Common questions
What is guselkumab?
Guselkumab is a medicine that helps manage moderate to severe plaque psoriasis by targeting a specific part of your immune system.
What does 'double-blind' mean?
It means neither you nor your study doctor will know whether you are receiving the real medicine (guselkumab) or a dummy treatment (placebo) until after the study is over. This helps keep the results fair.
How long will the study last?
The main part of the study is planned to last about 68 weeks, and you would have regular appointments during this time.
Will I have to pay to be in the study?
No, you will not have to pay for the study medicine or study-related appointments and tests.
Can I leave the study at any time?
Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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