Active not recruitingPHASE3INTERVENTIONAL

A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis

This research study is looking at a new medicine, TAK-279, for people with moderate to severe plaque psoriasis. The main goal is to understand its side effects and how well patients can take it over a long period. This is a "Phase 3" study, which means it’s one of the final stages of testing before a medicine might be made widely available. Participants will receive TAK-279 and be in the study for up to 217 weeks (about four years), including time for checks at the beginning, during treatment, and after stopping. You'll have regular visits to your clinic. This study is both for new participants and for those who have been part of previous TAK-279 studies, allowing for longer-term monitoring of the medicine's effects.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Takeda

Enrolment target

2,099

Start

04 Sep 2024

Estimated completion

05 Aug 2029

Plaque Psoriasis

What is this study about?

This study is about a new medicine called TAK-279, which is being tested for people who have moderate to severe plaque psoriasis. Plaque psoriasis is a common, long-lasting skin condition that causes red, scaly patches on the skin. "Moderate to severe" means the psoriasis affects a significant part of the body or has a big impact on daily life. The main reason for this study is to carefully look at how safe TAK-279 is and whether people can take it without too many problems over a long time. It’s important to find out about any possible side effects.

This is a 'Phase 3' study, which means the medicine has already been tested in smaller groups of people and shown some promise. This larger study helps researchers get a better overall picture of the medicine's safety and how well it works before it can be considered for wider use. It's an important step in developing new treatments.

The study is split into two main parts. Part A is for people who haven't been in a TAK-279 study before, and they will receive the medicine for up to 52 weeks (about a year). If they complete Part A successfully, they might be able to continue into Part B. Part B is for people who either finished Part A or completed certain earlier TAK-279 studies. They can then continue receiving the medicine for up to an additional 156 weeks (about three years). This long-term follow-up is very important for understanding the full effects of the medicine.

Key takeaways

Tests new drug TAK-279 for moderate to severe plaque psoriasis.
Mainly checks safety and how well people tolerate the medicine.
Study lasts up to around four years with regular clinic visits.
All accepted participants will receive TAK-279.
Open to new participants and those from specific earlier TAK-279 studies.

Who may be eligible?

To join Part A of this study, you need to be at least 18 years old and have been diagnosed with chronic plaque psoriasis for at least six months. Your psoriasis must be considered moderate to severe, meaning it covers at least 10% of your body and meets certain severity scores (like PASI 12 or more, and sPGA 3 or more). You should also be someone for whom doctors would typically consider treatments like light therapy (phototherapy) or stronger medicines that affect your whole body (systemic therapy).

There are also reasons why you might not be able to join. For example, if you have other types of psoriasis that aren't plaque psoriasis (like pustular or guttate), or if you need strong ongoing medications for certain immune system conditions. The study doctors will also check for any major ongoing health problems like serious heart, kidney, or liver conditions that could make taking part unsafe.

If you're joining Part B, you must have already completed a specific treatment period of one of the earlier TAK-279 studies or Part A of this current study. The doctors will check to make sure you're still suitable to continue.

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 had chronic plaque psoriasis for at least 6 months?
Is your plaque psoriasis considered moderate to severe?
Are you suitable for treatments like light therapy or stronger medications for psoriasis?
Do you not have other serious health problems that might prevent you from joining?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first go through a screening period, which lasts up to 35 days. During this time, the study team will do checks to make sure you're a good fit for the study. If you qualify, you will receive the study medicine, TAK-279. This medicine will be given to you for up to 52 weeks if you're in Part A, or up to an additional 156 weeks if you're in Part B.

Throughout the study, which could last a total of up to 217 weeks (about four years), you'll need to visit the study clinic many times. These visits are to monitor your health, check how your psoriasis is responding, and see if you're having any side effects. After your treatment period, there will be a follow-up period of 4 weeks to check on your health once you've stopped the medicine.

Potential risks and benefits

Participating in a study like this might offer some potential benefits, such as receiving a new medicine for your psoriasis that isn't yet widely available, and having close medical monitoring of your condition. However, it's also important to be aware of potential risks. As with any new medicine, TAK-279 may have side effects, some of which might not be fully known yet. The study team will closely monitor you for these. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (278)

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

Total Dermatology
Verified postcode
Birmingham, United States
University of Alabama Hospital - Whitaker Clinic -
Verified postcode
Birmingham, United States
Cahaba Dermatology Skin Health Center
Verified postcode
Hoover, United States
Medical Dermatology Specialists
Verified postcode
Phoenix, United States
Saguaro Dermatology Associates, LLC - Probity - PPDS
Verified postcode
Phoenix, United States
Noble Clinical Research
Verified postcode
Tucson, United States
Johnson Dermatology Clinic
Verified postcode
Fort Smith, United States
Burke Pharmaceutical Research
Verified postcode
Hot Springs, United States
Zenith Research, Inc.
Verified postcode
Beverly Hills, United States
First OC Dermatology Research Inc.
Verified postcode
Fountain Valley, United States
Center for Dermatology Clinical Research
Verified postcode
Fremont, United States
Long Beach Research Institute
Verified postcode
Long Beach, United States

Common questions

What is TAK-279?

TAK-279 is a new medicine being tested for people with moderate to severe plaque psoriasis, to see if it's safe and effective.

How long does the study last?

The study can last up to 217 weeks (about four years) in total, including screening, treatment, and follow-up periods.

Who can join this study?

Adults (18+) with moderate to severe plaque psoriasis who meet specific health and psoriasis criteria can join. Previous participants in specific TAK-279 studies may also be eligible for a longer-term part of this study.

Will I get the new medicine, or a dummy treatment?

All participants accepted into this particular study will receive the TAK-279 study treatment.

Can I stop participating if I want to?

Yes, you can leave the study at any time, for any reason, and it won't affect your regular medical care.