Active not recruitingOBSERVATIONAL

Tilrdakizumab Almirall

This study is investigating a medicine called tildrakizumab for people in the UK who have moderate to severe plaque psoriasis. Psoriasis is a skin condition that can cause red, scaly patches. Tildrakizumab works by targeting a specific protein in the body, which helps reduce inflammation. The main goal of this research is to understand exactly how tildrakizumab works. Researchers will look at tiny cells in skin samples from people with psoriasis before and after they start taking the medicine. They want to see what changes happen early on (after 2 weeks) and later (after 16 weeks) to better understand how the treatment improves psoriasis over time. This could help us develop even better treatments in the future.

At a glance

Status

Active not recruiting

Sponsor

University Hospital Schleswig-Holstein

Enrolment target

Start

27 Jun 2023

Estimated completion

30 Apr 2026

Psoriasis

What is this study about?

This research study is about a medicine called tildrakizumab, which is used to treat people in the UK with moderate to severe plaque psoriasis. Plaque psoriasis is a common, long-lasting skin condition where the body produces new skin cells too quickly. This causes thick, red, scaly patches on the skin that can be itchy or painful.

Tildrakizumab works by targeting a specific part of the body's immune system, a protein called IL-23. By blocking this protein, the medicine helps reduce the inflammation that causes psoriasis symptoms. The scientists want to explore in detail how this medicine affects the skin at a very tiny level. They'll be looking at certain types of cells in the skin to understand how tildrakizumab brings about both short-term and longer-lasting improvements in psoriasis.

To do this, a small number of patients with moderate to severe psoriasis will have tiny skin samples taken from their affected areas, and also from healthy skin, before they start treatment. More samples will be taken from nearby skin areas after 2 weeks and again after 16 weeks of taking tildrakizumab. By carefully studying these samples, researchers hope to get a clearer picture of how the medicine works to heal the skin and keep it clear.

Key takeaways

This study is exploring how a psoriasis medicine called tildrakizumab works.
It's for adults (18+) with moderate to severe plaque psoriasis in the UK.
Researchers will study tiny skin samples before and after treatment to understand the medicine's effects.
The goal is to learn more about how tildrakizumab helps and how its benefits last.
Participation involves receiving the medicine and having a few skin samples taken over 16 weeks.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years or older, who has been diagnosed with moderate to severe chronic plaque psoriasis. This means your psoriasis is affecting a fair amount of your body or is having a significant impact on your daily life.

You also need to be a suitable candidate for treatment with a specific type of medicine called an IL-23 inhibitor, and specifically tildrakizumab. Your doctor would help determine if this treatment is right for you, based on your medical history.

There are a few reasons why you wouldn't be able to join. For example, if you have a known allergy or severe reaction to IL-23 inhibitor medicines in general, or if you wouldn't be able to attend all the study appointments or follow the study instructions.

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?
Could you potentially receive tildrakizumab for your psoriasis?
Are you able to attend appointments and follow study instructions?
Do you have any known allergies to similar psoriasis medicines?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will first have tiny skin samples taken from areas affected by your psoriasis and from clear skin. You will then start taking the tildrakizumab medicine as prescribed by your doctor. After 2 weeks, and again at 16 weeks, you will have more tiny skin samples taken from areas near where the first samples were taken. Throughout the study, you will have regular visits with your care team to monitor your health and how the treatment is working. We don't have details on the exact number of visits, but expect a few visits over approximately a 4-month period (16 weeks) to collect the samples and check on your progress.

Potential risks and benefits

Potential benefits of taking part include receiving treatment for your psoriasis and contributing to a better understanding of how tildrakizumab works, which could help future patients. There are potential risks associated with taking small skin samples, such as minor pain, bruising, or a small risk of infection at the sample sites. As with any medicine, tildrakizumab can have side effects, which your doctor will discuss with you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

CCIM, Institut für Entzündungsmedizin UKSH Lübeck
Verified postcode
Lübeck, Germany

Common questions

What is plaque psoriasis?

Plaque psoriasis is a long-lasting skin condition that causes thick, red, scaly patches on the skin, often accompanied by itching or pain.

What is tildrakizumab?

Tildrakizumab is a medicine used to treat moderate to severe plaque psoriasis by targeting a specific protein in your immune system to reduce inflammation.

Will I get the medicine if I join the study?

Yes, if you are eligible and join the study, you will receive tildrakizumab as part of your treatment.

What are 'skin samples'?

Tiny pieces of skin, about the size of a pencil eraser, are carefully removed for examination under a microscope. This helps researchers see how the medicine is affecting your skin cells.

How long will the study last?

The main part of the study where samples are taken will last for about 16 weeks (4 months) after you start treatment, though your normal treatment might continue longer.