A study investigating whether Bimekizumab can reduce liver inflammation in people with psoriatic disease

Plain English summary of protocol

Background and study aims
People with psoriasis and psoriatic arthritis (psoriatic disease) are at increased risk of developing liver disease, including non-alcoholic fatty liver disease, also known as metabolic dysfunction-associated steatotic liver disease (MASLD). Liver problems may affect general health and quality of life and can also make treatment of psoriatic disease more difficult. Previous research by the study team suggests that newer treatments for psoriatic disease, such as Bimekizumab, may help improve liver health.

This study aims to investigate the effect of Bimekizumab on liver inflammation and scarring in people with psoriatic disease using a new non-invasive MRI scanning technique. The study will recruit 30 participants who are about to start Bimekizumab as part of their routine care. Participants will undergo MRI scans before starting treatment and again around 6 months later. The scans will mainly assess the liver, but will also provide information about other organs including the heart, lungs, kidneys, pancreas and spleen. The study will also collect information about participants’ psoriatic disease symptoms to better understand how Bimekizumab works in the body.

Who can participate?
Adults aged 18 years and over with psoriasis or psoriatic arthritis who are due to start Bimekizumab treatment as part of their routine clinical care. Participants must be willing and able to undergo MRI scans before and after starting treatment.

What does the study involve?
The study involves up to four visits.
At the screening visit, participants will provide informed consent, undergo eligibility assessments, complete questionnaires about their health and psoriatic disease symptoms, and provide blood samples. Participants will also be given a stool sample collection kit and diet questionnaire to complete at home and return by post.
Participants will undergo an MRI scan before starting Bimekizumab treatment. The date Bimekizumab treatment begins (baseline/Day 0) will be recorded as part of the study, although no additional clinic visit is required for this.
Around 24 weeks after treatment begins, participants will attend a follow-up visit where health assessments, questionnaires and blood tests will be repeated. Participants will also complete a second stool sample collection and diet questionnaire.
A second MRI scan will be performed around 24 weeks after starting Bimekizumab to assess changes in the liver and other organs. Where possible, study visits and MRI scans will be scheduled on the same day to reduce the number of visits required.

What are the possible benefits and risks of participating?
There may be no direct benefit from taking part in this study. However, participants will undergo two MRI scans that would not normally be performed as part of routine care. These scans may identify changes suggestive of liver disease or other abnormalities. Information gained from this study may also help improve understanding and future treatment of liver disease in people with psoriatic disease.

Taking part in the study will involve additional time at clinic visits for study assessments and questionnaires. Blood samples taken as part of the study may cause temporary discomfort, bruising or, rarely, fainting. Wherever possible, research blood samples will be taken at the same time as routine NHS blood tests.

Bimekizumab is prescribed as part of routine NHS care for psoriasis and psoriatic arthritis. As with any medication, there are potential side effects and risks associated with treatment, which participants should discuss with their treating doctor.

MRI scans are considered safe and do not involve exposure to ionising radiation (x-rays). However, MRI scanning is not suitable for everyone because it uses a strong magnet. Participants will undergo safety screening before the scan, particularly if they have certain metal implants, medical devices or metal fragments in the body.

There is no evidence that MRI is harmful during pregnancy, but pregnant individuals should not take part as a precaution. Rarely, tattoos may become warm during MRI scanning. Participants will be advised to inform the MRI operator immediately if they experience any discomfort during the scan.

Where is the study run from?
The study will be run at approximately five NHS secondary care hospitals in the UK. Participants will be recruited through dermatology and rheumatology departments caring for adults with psoriasis or psoriatic arthritis.

When is the study starting and how long is it expected to run for?
The study is expected to begin in June 2026. Recruitment is anticipated to take place over approximately 12 months. Each participant will take part in the study for approximately 8 months. This duration includes the time between enrolment and starting Bimekizumab treatment, as treatment initiation may be delayed as part of routine NHS care pathways.

Who is funding the study?
The trial is funded by UCB Biopharma SRL (Belgium)

Who is the main contact?
Mimi Bogale
Trial Manager
balance@ndorms.ox.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England

Study participating centres

Results and Publications

Study outputs

Additional files

49535 BALANCE_PIS_V1.0_16Mar2026.pdf

Participant information sheet

49535 BALANCE_Protocol_V1.0_16Mar2026.pdf

Protocol file

Editorial Notes

30/07/2026: The study participating centres were updated. The target sample size was corrected from 10 to 30.
14/05/2026: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).