Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Immunological and functional characteristics of T memory-like cells in psoriasis under treatment with deucravacitinib - IM011-1115

This research, called IM011-1115, is designed to understand more about how a treatment called SOTYKTU (also known as deucravacitinib) works for plaque psoriasis. Specifically, it's exploring how this medicine affects certain immune cells in your body, called TRM-like cells. These cells might play a role in psoriasis. The study aims to see if SOTYKTU changes the number and activity of these cells over 24 weeks of treatment. By looking at these changes, scientists hope to learn more about how SOTYKTU helps improve psoriasis and reduce the inflammation associated with the condition. This is an important step in understanding and improving treatments for psoriasis.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Charite Universitaetsmedizin Berlin KöR

Enrolment target

Start

06 Sep 2024

Plaque Psoriasis

What is this study about?

This research study, known as IM011-1115, is designed to learn more about how a medicine called SOTYKTU (also known as deucravacitinib) works in people living with plaque psoriasis. Psoriasis is a skin condition that causes red, scaly patches. We know SOTYKTU is a treatment for psoriasis, and this study aims to dig deeper into *how* it helps.

The main goal is to look at how SOTYKTU affects specific immune cells in your body, called TRM-like cells. These cells are thought to be involved in ongoing inflammation, which is a key part of psoriasis. Researchers want to see if SOTYKTU changes the number of these cells and how active they are after 24 weeks of treatment. By understanding this, we can get a clearer picture of how the medicine reduces the symptoms of psoriasis.

The study will also explore if the changes in these TRM-like cells are linked to a reduction in inflammation markers in your body. This includes looking at certain signals (called cytokines like IL-17, IL-22, and IL-23) that contribute to psoriasis. All this information helps us to better understand psoriasis and how treatments like SOTYKTU work at a detailed level, which can lead to better ways to manage the condition in the future.

Key takeaways

This study investigates how SOTYKTU treats plaque psoriasis by looking at specific immune cells.
It aims to understand the impact of SOTYKTU on TRM-like immune cells over 24 weeks.
Researchers hope to link changes in these cells to reduced inflammation in psoriasis.
Participants will receive SOTYKTU tablets and have regular health checks for 24 weeks.
The study is for adults aged 18 and over, both men and women with plaque psoriasis.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. There is no upper age limit. The study is open to both men and women.

More specific health requirements and medical history checks will be done by the study doctors to make sure the study is a good fit for you and that it's safe for you to participate. This usually involves reviewing your medical records and having some health checks.

If you have plaque psoriasis and fit the age criteria, discussing this study with your doctor is a good next step to see if you might be eligible.

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 plaque psoriasis?
Are you able to attend regular clinic appointments?
Are you open to taking a study medication (SOTYKTU tablets) for 24 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given SOTYKTU 6 mg film-coated tablets to take as directed by the study team. You will be taking the medication for a period of 24 weeks. During this time, you can expect to have several visits to the study clinic. These visits will involve various assessments, such as blood tests, to help the researchers understand how the medicine is affecting your TRM-like cells and overall health. The exact schedule of visits and assessments will be provided by the study team, but generally, studies like this involve regular check-ups and monitoring over the 24-week treatment period.

Potential risks and benefits

Taking part in a study like this might offer the potential benefit of closer medical monitoring of your psoriasis and access to a medication being further investigated for its effects. However, there are potential risks, as with any medication, which will be fully explained to you by the study team. You might experience side effects from the medication, and these will be carefully monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Germany

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. It's caused by an overactive immune system that makes skin cells grow too quickly.

What is SOTYKTU?

SOTYKTU (deucravacitinib) is a medicine used to treat moderate to severe plaque psoriasis. It works by targeting specific pathways in the immune system that contribute to the condition.

What are 'TRM-like cells'?

TRM-like cells are a type of immune cell found in the body. In the context of psoriasis, they might play a role in keeping the inflammation going in the skin. This study wants to see how SOTYKTU affects these cells.

How long will the study last for me?

If you join, you will be taking the study medication for 24 weeks. There will be regular clinic visits and health checks during this time.

Will I know if the treatment is working?

The study team will monitor your psoriasis and your overall health during the study. They will share relevant information with you as part of your care within the research framework. This study also gathers information to better understand the scientific effects of the treatment rather than just evaluating personal response.