Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Multicenter, Double-Blind Trial to Evaluate the Efficacy, Safety, and Tolerability of Zasocitinib (TAK-279) Compared to Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis

This study is a major clinical trial (Phase 3) looking into a new medication called Zasocitinib (TAK-279) for adults who have moderate to severe plaque psoriasis. We want to see how effective it is at clearing up skin patches, how safe it is to use, and if people can take it without too many problems. The study will compare Zasocitinib to an approved psoriasis treatment called Deucravacitinib (SOTYKTU) and also to a placebo (a dummy pill with no active medicine). Participants will be randomly assigned to receive one of these treatments. The main goal is to find out if Zasocitinib can completely clear the skin patches after 16 weeks of treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Takeda Development Center Americas Inc.

Enrolment target

371

Start

19 Aug 2025

Moderate to Severe Plaque Psoriasis

What is this study about?

This important study is testing a new medication called Zasocitinib (also known as TAK-279) for adults living with moderate to severe plaque psoriasis. Plaque psoriasis is a long-lasting skin condition that causes red, scaly patches on the skin, and for many, it can have a big impact on daily life. This trial is in its 'Phase 3,' which means it's one of the final steps before a new medicine might be considered for approval. At this stage, we need to be very sure about how well it works and how safe it is compared to current treatments.

The study will involve comparing Zasocitinib with two other options. One is Deucravacitinib (which you might know as SOTYKTU), a medicine already approved for treating psoriasis. The other is a 'placebo,' which is a tablet that looks exactly like the other medicines but doesn't contain any active drug. This helps us truly understand the effects of the active medicines. Participants will be randomly assigned to one of these groups, and neither they nor their doctors will know which treatment they are receiving. This setup helps to ensure the results are fair and unbiased.

The main thing we want to find out is whether Zasocitinib can lead to absolutely clear skin for people with psoriasis after 16 weeks. We'll also be looking at how much the psoriasis improves in general, whether it helps achieve almost clear skin, and if doctors see a significant improvement. Throughout the study, we'll carefully monitor for any side effects and changes in general health to make sure the treatment is safe.

Key takeaways

Tests a new psoriasis medicine (Zasocitinib) against an existing one and a dummy pill.
Aims to see if the new medicine can completely clear moderate to severe plaque psoriasis.
Participants will take tablets, and neither they nor their doctors will know which treatment they are receiving.
Involves regular clinic visits, physical checks, blood tests, and heart monitoring.
Adults (18+) with moderate to severe plaque psoriasis are invited to participate.

Who may be eligible?

To be part of this study, you need to be an adult, at least 18 years old, and have been diagnosed with moderate to severe plaque psoriasis. This means your psoriasis is affecting a significant part of your body and/or is causing noticeable distress or problems.

There will be other specific medical details that the study team will need to check to make sure the study medicine is right and safe for you. These might include your general health, other medical conditions you have, and any other medicines you are currently taking.

Both men and women can participate in this study. The study team will review all your medical information carefully to confirm if you meet all the necessary requirements.

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 moderate to severe plaque psoriasis?
Are you able to attend regular clinic appointments?
Are you willing to take study medication as directed?
Are you okay with not knowing which treatment you are receiving (new medicine, existing medicine, or placebo)?

Answer every question to see your result.

What does participation involve?

Taking part in this study will involve regular visits to the clinic over a period of time. You will be given either the new medicine (Zasocitinib), an existing medicine (SOTYKTU), or a dummy pill (placebo) in tablet form. You won't know which one you are taking. During your visits, the study team will conduct check-ups, which may include physical examinations, blood tests, and heart tracings (ECGs). They will also look at your skin to see how your psoriasis is improving and ask you about how you are feeling and any side effects you might be having. There will be follow-up appointments after you finish taking the study medication to ensure your well-being. The total duration of your participation, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Participating in this study could offer several potential benefits. You might gain access to a new medication for psoriasis that isn't widely available yet, and your psoriasis could improve significantly. You'll also receive close medical attention and monitoring throughout the trial. However, there are potential risks, as any new medicine can have side effects, and some might be serious. It's also possible the treatment might not work for you, or you could be given the placebo. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Czechia
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Unverified
France
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Unverified
Bulgaria
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Unverified
Latvia
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Unverified
Poland

Common questions

What is plaque psoriasis?

Plaque psoriasis is a common, long-lasting skin condition that causes red, flaky, crusty patches covered with silvery scales. These patches can be itchy or sore.

What does 'Phase 3 trial' mean?

Phase 3 is a major step in testing new medicines. It means the medicine has already been through earlier safety tests and now needs to be compared to existing treatments or a placebo on a larger group of people to see how effective and safe it really is.

What is a 'placebo'?

A placebo is a substance or treatment that looks exactly like the real medicine but contains no active drug. It helps researchers understand if the effects people experience are truly due to the medicine or something else.

Will I know if I'm getting the new medicine or not?

No, in this study, neither you nor your doctor will know whether you are receiving Zasocitinib, SOTYKTU, or the placebo. This is called 'double-blind' and it helps make sure the study results are fair and unbiased.

What will happen if my psoriasis doesn't improve?

The study team will monitor your progress closely. If your psoriasis doesn't improve or gets worse, or if you experience any concerning side effects, they will discuss your options with you, and you can withdraw from the study at any time.