Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A Mono-Center, Prospective Biomarker Study to investigate the differences in the inflammatory gene expression signature, the distribution of immune cells, psoriasis-driving factors and signaling molecules between classic and hard-to-treat psoriasis plaques and the effects of TYK2 blockade with deucravacitinib – MED-PSO

This study is investigating a medicine called SOTYKTU for people with moderate to severe plaque psoriasis. Psoriasis causes thick, red, scaly patches on the skin. Sometimes these patches are considered 'classic,' and others are 'hard-to-treat.' The main goal is to see if SOTYKTU changes the activity of certain genes linked to inflammation and psoriasis, in both classic and hard-to-treat patches after 16 weeks of treatment. Researchers will also be looking at how immune cells behave and other factors related to psoriasis symptoms like itching and pain. This is a Phase IV study, meaning the medicine is already approved, and researchers are gathering more information about its effects in a real-world setting.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Charite Universitaetsmedizin Berlin KöR

Enrolment target

Start

17 Jan 2025

moderate to severe plaque psoriasis

What is this study about?

This research study, called MED-PSO, is all about understanding how a medicine named SOTYKTU works in people who have moderate to severe plaque psoriasis. When you have psoriasis, your immune system mistakenly attacks healthy skin cells, causing them to grow too quickly and form patches. These patches can often be itchy, sore, and sometimes appear in places that are difficult to treat, like on your scalp, palms, or soles of your feet.

The main aim of this study is to compare how SOTYKTU affects two different types of psoriasis patches: 'classic' ones and 'hard-to-treat' ones. The researchers are particularly interested in seeing if the medicine changes the activity of specific 'genes' (which are like instructions in your body's cells) that are involved in inflammation and psoriasis. They will also be looking at how different immune cells behave in these patches, as well as checking on other signs and symptoms of psoriasis like itching and pain.

SOTYKTU is a medicine that's already approved for use, so this study is what's called a 'Phase IV' trial. This means doctors are gathering more information about the medicine's effects and how it works in more detail in people who are treated with it. The findings could help doctors better understand how to treat different types of psoriasis in the future.

Key takeaways

The study uses an approved medicine, SOTYKTU, for moderate to severe plaque psoriasis.
Researchers want to understand how SOTYKTU affects genes and immune cells in different psoriasis patches.
It lasts for 16 weeks of treatment with daily SOTYKTU tablets.
Participation involves regular visits for health checks and monitoring.
It aims to improve understanding of psoriasis and its treatment.
It's open to adults aged 18 and over with the specific type of psoriasis.

Who may be eligible?

To be able to join this study, you need to be an adult, aged 18 years or older. The study is open to both men and women.

Specifically, you must have been diagnosed with moderate to severe plaque psoriasis. This means your psoriasis affects a significant area of your body and is considered serious by your doctor. The study will also be looking at how the treatment works on different types of psoriasis patches, including those that are generally more challenging to treat.

There will be other specific health requirements that only a doctor can fully explain. These might include your general health, other medical conditions you have, and any other medications you are currently taking. If you are interested, it's really important to discuss all these details with your doctor or the study team.

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 able to attend regular study appointments?
Are you generally in good health, apart from your psoriasis?
Are you willing to take a study medication for 16 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive SOTYKTU tablets, 6 mg once a day, for 16 weeks. You would have regular visits to the study centre, where doctors and nurses would monitor your health and how your psoriasis is responding to the treatment. These visits might include physical examinations, blood tests, and potentially small skin samples (biopsies) from your psoriasis patches to check changes at a cellular level.

Throughout the study, you would be asked about your symptoms, such as how much your skin itches or hurts, to help the researchers understand the medicine's impact. The total duration of your active participation in receiving the treatment would be 16 weeks, followed by further assessments to see the treatment's effects. The study team would explain the exact schedule of visits and what each visit would involve.

Potential risks and benefits

Participating in a study like this could potentially offer benefits, such as receiving a psoriasis treatment that may improve your condition under close medical supervision. However, like all medicines, SOTYKTU can have side effects, and some risks are involved. The study team will explain all known side effects and potential risks associated with the treatment and the procedures involved, like blood tests or skin biopsies. You will be provided with full information so you can make an informed decision, and you always 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.

—
Unverified
Germany

Common questions

What is SOTYKTU?

SOTYKTU is a medicine used to treat moderate to severe plaque psoriasis. It works by targeting specific parts of your immune system that cause psoriasis.

What kind of psoriasis are they studying?

This study is focused on moderate to severe plaque psoriasis, including both typical patches and those that are often harder to treat.

How long will I take the medicine?

If you join the study, you will take the SOTYKTU tablets once a day for 16 weeks.

What does 'Phase IV' mean?

Phase IV means the medicine is already approved and available. This study is gathering more detailed information about how it works in real-world use.

Will I have to do anything special?

You'll have regular visits for check-ups, blood tests, and possibly small skin samples. You'll also be asked about your symptoms like itching and pain.