A Phase 3, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who are Either Biologic DMARD-Naïve or Biologic DMARD-Experienced, Including Those With Inadequate Response to Biologic DMARDs
This research is a long-term study that aims to understand the safety, how well it's tolerated, and how effective a new medicine called Zasocitinib (also known as TAK-279) is for people living with active psoriatic arthritis. The study includes individuals who haven't tried certain powerful arthritis medicines before, as well as those who have but perhaps didn't get enough relief from them. Participants will be randomly given either Zasocitinib at different doses or a dummy medicine (placebo). Researchers will closely monitor for any side effects and see how much the medicine improves arthritis symptoms and skin plaques over time. This is a large, important study (Phase 3) to confirm if this new treatment could be helpful.
At a glance
What is this study about?
This study is about a new medicine called Zasocitinib (or TAK-279) for people who have psoriatic arthritis. Psoriatic arthritis is a condition where your immune system attacks your joints, causing pain, swelling, and stiffness. It can also affect the skin, causing psoriasis.
The main goal of this study is to look at the long-term safety of Zasocitinib. This means researchers want to find out if there are any side effects over a longer period. They also want to see how well people tolerate the medicine, meaning how easily they can take it without too many unwanted effects. On top of that, they'll be checking how effective Zasocitinib is at reducing symptoms of psoriatic arthritis, like joint pain and skin problems.
This is a 'Phase 3' study, which means it's a large and important step before a new medicine can be considered for wider use. The study includes people with psoriatic arthritis who are either new to certain types of strong arthritis medicines (called 'biologic DMARDs') or who have tried them before but found they didn't work well enough. Participants will be given either Zasocitinib or a dummy medicine (placebo) to ensure a fair comparison.
Key takeaways
- This study is testing a new medicine, Zasocitinib, for psoriatic arthritis.
- It's a long-term study focusing on safety and how well the medicine works.
- Participants will get either Zasocitinib or a dummy medicine.
- The study includes people new to certain treatments and those for whom previous treatments didn't work well.
- Regular health checks and assessments of joints and skin will be part of the study.
- Participation involves periodic visits over several years.
Who may be eligible?
To join this study, you need to be an adult, 18 years or older, with active psoriatic arthritis. Both men and women can take part.
Active psoriatic arthritis usually means you have ongoing joint pain, swelling, or stiffness. The study is open to people who haven't yet tried certain powerful arthritis medicines called 'biologic DMARDs', or for those who have tried them but didn't get enough relief from their symptoms.
The research team will review your medical history and current health to make sure the study is a good fit for you and that it's safe for you to participate.
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 active psoriatic arthritis?
- Have you either not tried strong arthritis medicines (biologic DMARDs) before, OR found they didn't work well enough for you?
- Are you able to attend regular clinic visits for several years?
What does participation involve?
If you decide to take part in this study, you'll be given either the new medicine Zasocitinib or a dummy medicine (placebo). You won't know which one you're receiving. You'll have regular visits to the clinic where the study team will monitor your health very closely. These visits will involve checks of your vital signs (like blood pressure and heart rate), taking blood and urine samples, and physical examinations. They will also assess your psoriatic arthritis symptoms, including your joints and skin.
These check-ups will happen at specific times throughout the study, usually at 24 weeks, 48 weeks, and 104 weeks (which is about two years). The total duration of your participation in this study could be quite long, possibly several years, as it's designed to look at long-term effects. The study team will explain the full schedule of visits and what each visit involves before you make any decisions.
Potential risks and benefits
Locations (13)
- —UnverifiedGermany
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedCzechia
- —UnverifiedCroatia
- —UnverifiedPortugal
- —UnverifiedPoland
- —UnverifiedLatvia
- —UnverifiedBulgaria
- —UnverifiedFrance
- —UnverifiedEstonia
- —UnverifiedHungary
Common questions
What is psoriatic arthritis?
It's a type of arthritis that affects some people with psoriasis, causing joint pain, swelling, and stiffness, and sometimes skin rashes.
What is Zasocitinib?
It's an experimental medicine being tested to see if it can help treat psoriatic arthritis symptoms.
What does 'Phase 3 study' mean?
It means this is a large research study comparing the new medicine to other treatments or a dummy medicine, to see if it's safe and effective before it can be approved.
What is a 'placebo'?
A placebo is a dummy medicine that looks like the real medicine but contains no active drug. It helps researchers compare the effects accurately.
How long will I be in the study?
This is a long-term study, and your participation could last for several years, with regular check-ups at specific intervals like 24, 48, and 104 weeks.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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