Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis

This study is investigating a medicine called bimekizumab for people with moderate to severe plaque psoriasis, including those who also have psoriatic arthritis. The main goal is to understand how bimekizumab changes special markers, called 'gene expression biomarkers,' in skin cells. This helps researchers learn more about how the medicine works to improve psoriasis over 48 weeks. By looking closely at skin samples, the study aims to get a deeper understanding of the drug's effects on the body. We are also looking at a group of healthy volunteers to compare results.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

UCB Biopharma SRL

Enrolment target

Start

29 Jul 2024

Estimated completion

14 Mar 2028

Moderate to Severe Plaque Psoriasis Psoriatic Arthritis

What is this study about?

This study is looking at a new medicine called bimekizumab. It's for people who have plaque psoriasis that is moderate to severe. Some participants in the study will also have psoriatic arthritis, which is a type of arthritis linked to psoriasis. We're trying to understand how this medicine works at a very detailed level inside your skin cells. Our main goal is to look at something called 'gene expression biomarkers' after 48 weeks of treatment.

Think of gene expression biomarkers as tiny signals within your cells that can tell us a lot about what's happening. By examining these signals, we can learn exactly how bimekizumab might be changing the way your body responds to psoriasis. This helps us understand if the medicine is doing its job and how effectively it is treating the condition.

Understanding these changes is important because it can help doctors and researchers develop even better treatments for psoriasis and psoriatic arthritis in the future. We're also comparing these findings to a group of healthy volunteers to see the differences. This study aims to add to our knowledge of how bimekizumab works to help people with these conditions.

Key takeaways

The study explores how bimekizumab affects skin cells in psoriasis and psoriatic arthritis.
It aims to understand the drug's action at a detailed, cellular level.
Participation involves receiving the study medicine and providing skin biopsies.
The study lasts for at least 48 weeks to observe long-term effects.
It helps advance our understanding for future psoriasis and psoriatic arthritis treatments.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have been diagnosed with plaque psoriasis for at least 6 months, and your psoriasis needs to be moderate to severe, covering at least 10% of your body surface. Your doctor would likely consider you a candidate for stronger treatments like systemic therapy or light therapy.

If you also have psoriatic arthritis, you need to have been diagnosed for at least 6 months and meet specific criteria showing your arthritis is active, with some tender and swollen joints. You'll also need to weigh less than 120 kg. Women participating must not be pregnant or breastfeeding, and if they could become pregnant, they must agree to use reliable birth control during and for a period after the study.

We are also looking for a small group of healthy volunteers for comparison. These individuals must be at least 18 years old, generally healthy, and also weigh less than 120 kg.

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 or older?
Do you have moderate to severe plaque psoriasis diagnosed for at least 6 months?
If you have psoriatic arthritis, is it still active with tender/swollen joints?
Are you considered by your doctor for stronger psoriasis treatments (like systemic or light therapy)?
Are you able to maintain your usual sun exposure habits?
Do you weigh less than 120 kg (about 19 stone)?
If you are a woman who could become pregnant, are you willing to use reliable birth control during and for a period after the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the study medicine, bimekizumab. A key part of the study involves providing skin biopsies, which are small skin samples, to help us understand how the medicine is working at a cellular level. These biopsies will be taken at different times during the study, including at the beginning and after 48 weeks of treatment.

You will have regular visits to the clinic for medical check-ups, blood tests, and to assess your psoriasis and psoriatic arthritis. These visits will help us monitor your health and how well the treatment is working. It's important that you don't change your usual sun exposure habits and use sunscreen if you'll be in the sun for long periods. The total duration of your participation in the study, including follow-up, will be clarified by the study team.

Potential risks and benefits

Participating in this study might offer you access to a new treatment for your psoriasis or psoriatic arthritis, and it helps doctors learn more about these conditions. However, like all medicines, bimekizumab may have side effects, and some procedures like skin biopsies carry minor risks like bruising or infection. You will be told about all known risks before you decide to join. Remember, you have the right to withdraw from the study at any time without affecting your medical care.

Locations (14)

Ps0039 50140
Verified postcode
Birmingham, United States
Ps0039 50162
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Fountain Valley, United States
Ps0039 50283
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Tampa, United States
Ps0039 50110
Verified postcode
Ann Arbor, United States
Ps0039 50643
Verified postcode
Rochester, United States
Ps0039 50491
Verified postcode
Pittsburgh, United States
Ps0039 40515
Verified postcode
Berlin, Germany
Ps0039 40287
Verified postcode
Frankfurt am Main, Germany
Ps0039 40072
Verified postcode
Freiburg im Breisgau, Germany
Ps0039 40347
Verified postcode
Lodz, Poland
Ps0039 40757
Verified postcode
Poznan, Poland
Ps0039 40625
Verified postcode
Warsaw, Poland

Common questions

What is bimekizumab?

Bimekizumab is the name of the investigational medicine being studied for moderate to severe plaque psoriasis and psoriatic arthritis.

What are 'gene expression biomarkers'?

These are like tiny clues inside your skin cells that help us understand how the medicine is changing the way your body responds to psoriasis.

Will I have to get a skin biopsy?

Yes, if you participate in the main groups of this study, you will need to provide skin biopsies so researchers can study the skin cells in detail.

How long will the study last for me?

The main part of the study where we look at the medicine's effect on skin cells is 48 weeks, but the full duration of your participation will be explained by the study team.

Can I still go in the sun?

You should not change your usual sun exposure habits during the study and use sunscreen if you expect to be in the sun for long periods.