A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator-Controlled Study With a Randomized Withdrawal and Retreatment Period to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis
This research study is looking at a new medicine called ZASOCITINIB (or TAK-279) for adults who have moderate to severe plaque psoriasis. Psoriasis is a skin condition that causes red, scaly patches. The study aims to see if this new medicine is effective at clearing these patches and if it's safe to use, compared to a well-known treatment called Otezla and a dummy pill (placebo). Participants will take a specific dose of one of these medicines, and researchers will carefully check how their skin improves and if they experience any side effects. This type of study, called a Phase 3 trial, is a crucial step to confirm if a new medicine works well enough to become widely available.
At a glance
What is this study about?
This research study is about finding better ways to treat moderate to severe plaque psoriasis. Plaque psoriasis is a common skin condition where your body produces new skin cells too quickly, leading to thick, red patches covered with silvery scales. It can be uncomfortable and sometimes affect daily life.
The main goal of this study is to test a new medicine called ZASOCITINIB (also known as TAK-279). Researchers want to see if this new medicine can help clear up psoriasis patches more effectively than current treatments, such as Otezla, and if it's generally safe for people to use. To do this, some participants will receive the new medicine, some will receive Otezla, and others will receive a placebo – which looks like the real medicine but contains no active drug. This helps scientists truly understand the effects of the new medicine.
During the study, doctors will regularly assess your skin to see how much your psoriasis has improved. They'll look at how clear your skin becomes and how much the scaling and redness reduce. They'll also closely monitor any side effects you might experience. The information gathered from this study will help determine if ZASOCITINIB could be a valuable new option for people living with plaque psoriasis.
Key takeaways
- This study is testing a new medicine (TAK-279) for moderate to severe plaque psoriasis.
- It compares the new medicine to an existing treatment (Otezla) and a dummy pill (placebo).
- The main aim is to see if the new medicine is effective at clearing psoriasis and is safe.
- Participation involves regular clinic visits and taking daily tablets.
- The study seeks to confirm if TAK-279 could be a new treatment option for psoriasis.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. There is no upper age limit.
Both men and women are welcome to participate. The study is specifically for individuals who have been diagnosed with moderate to severe plaque psoriasis.
Other specific health conditions or medications might affect whether you can join the study. If you're interested, the study team will ask you some questions about your health to see if it's suitable and safe for you to take part.
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 psoriasis?
- Are you currently in general good health apart from your psoriasis?
- Are you willing to attend regular clinic appointments for over a year?
What does participation involve?
If you decide to join this study, you will be given one of the study medicines: a new medicine called TAK-279, an existing treatment called Otezla, or a dummy pill (placebo). You won't know which one you're taking, nor will the study doctors, to keep the results fair. You'll take these film-coated tablets as instructed, likely every day.
Throughout the study, you'll have regular visits to the clinic. These visits will involve various checks, including physical exams, blood tests, and assessments of your psoriasis. Doctors will carefully measure how your skin is changing, such as the amount of redness, thickness, and scaling of your psoriasis patches. They will also ask about any side effects you might be experiencing.
After an initial treatment period (around 16 weeks), some participants might have a period where their treatment is stopped or changed. The total duration of your involvement could be up to 60 weeks (about 14 months) to see how long any improvements last and to continue monitoring your health.
Potential risks and benefits
Locations (9)
- —UnverifiedGermany
- —UnverifiedPoland
- —UnverifiedLatvia
- —UnverifiedHungary
- —UnverifiedGreece
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedCzechia
- —UnverifiedBulgaria
Common questions
What is 'plaque psoriasis'?
Plaque psoriasis is a common skin condition that causes red, scaly patches on the skin, often on elbows, knees, scalp, and lower back.
What does 'moderate to severe' mean?
This means your psoriasis covers a noticeable area of your body, is quite red, thick, or scaly, and might be significantly affecting your daily life.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the real medicine but contains no active drug. It helps researchers understand if the medicine is truly working or if improvements are due to other factors.
Will I know if I'm getting the new medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment you are receiving until after the study is complete, keeping the results unbiased.
How long will the study last?
Your involvement in the study could last up to 60 weeks, which is about 14 months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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