Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Subjects with Moderate-to-Severe Plaque Psoriasis

This important study, called a Phase 3 trial, is looking into a new medication named TAK-279 for adults who have moderate to severe plaque psoriasis – a skin condition causing red, scaly patches. The main goals are to find out how well TAK-279 works in clearing up these skin patches, how safe it is to use, and if people can tolerate it without too many side effects. To do this, some participants will receive TAK-279, others will get an existing treatment called Otezla, and some will receive a placebo (a dummy pill with no active medicine). By comparing these groups, researchers can understand if TAK-279 could be a helpful new option for managing psoriasis.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Takeda Development Center Americas Inc.

Enrolment target

235

Start

04 Mar 2024

Moderate to Severe Plaque Psoriasis

What is this study about?

This study is a Phase 3 clinical trial, which means it's one of the final stages of testing a new medicine before it can be considered for wider use. The medicine being tested is called TAK-279, and it's for people who have moderate to severe plaque psoriasis. This is a skin condition that causes red, scaly, and sometimes itchy patches on the skin.

In this study, researchers want to see how effective TAK-279 is at improving psoriasis compared to both a well-known psoriasis treatment called Otezla, and a 'placebo' (a dummy pill that looks like the active medicine but contains no drug). They will be looking closely at how much the skin patches clear up and if the medicine has any side effects. This kind of study helps doctors understand if TAK-279 could be a safe and useful new treatment option for people living with psoriasis.

The main things they'll be measuring are how many people achieve 'clear' or 'almost clear' skin according to a doctor's assessment, and how many see a significant improvement (at least 75% clearer) in their Psoriasis Area and Severity Index (PASI) score within 16 weeks. They'll also be checking for improvements in specific areas like the scalp and nails.

Key takeaways

This study is testing a new medication, TAK-279, for moderate to severe plaque psoriasis.
It's a Phase 3 study, meaning it's an important step in researching new treatments.
Participants will receive TAK-279, an existing treatment (Otezla), or a dummy pill (placebo).
The main goal is to see how well TAK-279 clears skin and if it's safe.
Close monitoring by doctors is a key part of participating.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old, with moderate to severe plaque psoriasis. This means your psoriasis has been assessed by a doctor and is causing a significant impact on your skin.

There will be other detailed health requirements, and a doctor will need to review your full medical history to make sure the study is a safe and suitable option for you. Not everyone with psoriasis will be able to take part, as specific health conditions or medications might prevent 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?
Have you been diagnosed with moderate to severe plaque psoriasis by a doctor?
Are you generally in good health apart from your psoriasis?
Are you able to attend regular clinic appointments for check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of several groups by chance – like drawing names from a hat. This means you could receive the new medicine (TAK-279), an existing medicine (Otezla), or a placebo (a dummy pill). You and your study doctor usually won't know which treatment you are receiving until the study is over, which helps make the results fair.

You will have regular visits to the clinic for check-ups, where doctors and nurses will monitor your health, assess your psoriasis, and ask about any side effects. These visits will involve physical examinations, blood tests, and discussions about how you are feeling. You will be taking tablets as part of the treatment.

The study will last for a certain period, and there will be follow-up visits to ensure your safety and monitor your progress even after you stop taking the study medication. The total duration of your involvement will be explained to you by the study team.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as access to a new treatment before it's widely available and closer monitoring of your health by medical professionals. However, there are also potential risks; the new medicine might cause side effects, or it might not work as well as expected. You might also receive a placebo, meaning your psoriasis may not improve during that period. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Poland
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Unverified
Italy
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Unverified
Germany

Common questions

What is 'plaque psoriasis'?

Plaque psoriasis is a common skin condition where skin cells grow too quickly, causing red, flaky, and sometimes itchy patches called 'plaques'.

What does 'Phase 3' mean for a study?

Phase 3 is an advanced stage of testing a new medicine, involving a larger number of patients to confirm how well it works and if it's safe before it can be considered for general use.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active drug. It helps researchers compare the new medicine's effects accurately.

Will I know if I'm getting the new medicine or the placebo?

No, this is a 'blinded' study, meaning you and your doctor typically won't know which treatment you are receiving. This helps keep the study fair and unbiased.

What if the new drug doesn't work for me?

The study will closely monitor your condition. If your psoriasis doesn't improve or gets worse, or if you experience significant side effects, the study doctors will discuss the best course of action with you.