Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF BIMEKIZUMAB IN THE TREATMENT OF SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS

This study is a long-term follow-up for people who have already started treatment with bimekizumab for psoriatic arthritis in earlier trials. Its main goal is to understand the long-term safety of bimekizumab, meaning researchers will carefully monitor any side effects that might happen. They will also look at how well the medicine continues to relieve symptoms of psoriatic arthritis over a longer period, such as reducing joint pain and improving skin conditions. This kind of study helps doctors understand the full picture of a new medicine's effects over extended use, which is really important for patient care.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

UCB Biopharma

Enrolment target

741

Start

11 Jul 2024

Psoriatic Arthritis

What is this study about?

This study is a long-term look at a medicine called bimekizumab, which is being tested for people who have psoriatic arthritis. Psoriatic arthritis is a type of arthritis that affects some people with psoriasis, causing painful, swollen joints and sometimes skin problems.

Researchers want to see how safe bimekizumab is over a longer period and how well it continues to help with the symptoms of psoriatic arthritis. This particular study is designed for people who have already taken bimekizumab in earlier smaller studies (called PA0010 or PA0011). It's common in drug development to follow patients for longer periods once a medicine has shown promise in initial trials. This helps to confirm a medicine's benefits and identify any less common side effects.

The study is called a 'Phase III' study, which means it's one of the final steps before a medicine might be considered for general use. The information gathered here is crucial for understanding the complete picture of bimekizumab's impact on people's health and well-being over time.

Key takeaways

This study is about the long-term effects of bimekizumab for psoriatic arthritis.
It aims to check both safety and how well the treatment continues to work over time.
Only people who were in earlier bimekizumab studies can join this one.
Participants will receive the active medicine, not a placebo.
The study will last for a long time, potentially over two years.

Who may be eligible?

This study is for adults aged 18 and over who have psoriatic arthritis. To be considered for this long-term study, you would have needed to take part in one of the previous studies involving bimekizumab (specifically PA0010 or PA0011).

Both men and women can take part. The previous studies would have evaluated your psoriatic arthritis to make sure it was active at the time, meaning you were experiencing symptoms like swollen and painful joints.

Currently, the study is open to people who have already been taking bimekizumab and fit these criteria, so it's not recruiting new patients who haven't been in the earlier trials.

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 active psoriatic arthritis?
Have you previously taken part in study PA0010 or PA0011?
Are you able to attend regular clinic visits and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you are eligible and decide to join this study, you would continue to receive the bimekizumab medicine. You would have regular visits to the clinic, which might involve physical examinations, blood tests, and discussions about your symptoms and any side effects you might be experiencing. These assessments are important for tracking how well the medicine is working and monitoring your general health.

The study aims to follow participants for a long time, possibly up to 140 weeks (about 2 years and 8 months) or more, to get a full understanding of the long-term effects of the medication. The exact number and timing of visits would be explained in detail by the study team.

Potential risks and benefits

Taking part in this study could offer the benefit of continuing to receive a treatment that may help manage your psoriatic arthritis symptoms over a longer period. However, like all medicines, bimekizumab can have side effects. Researchers will carefully monitor for any side effects, both expected and unexpected, to understand the long-term safety of the drug. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

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

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Unverified
Italy
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Unverified
Germany
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Unverified
Czechia
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Unverified
France
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Unverified
Hungary
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Unverified
Poland
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Unverified
Belgium
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Unverified
Spain

Common questions

What is psoriatic arthritis?

Psoriatic arthritis is a long-term condition that causes inflammation in the joints and can affect people who have psoriasis, a skin condition.

What is bimekizumab?

Bimekizumab is a medicine being studied as a treatment for psoriatic arthritis. It works by targeting specific parts of the immune system to reduce inflammation.

Why is this a long-term study?

Long-term studies help doctors understand how safe a medicine is and how well it works over many months or years, which is important for conditions like psoriatic arthritis that need ongoing treatment.

Will I get the actual medicine or a placebo?

This is an 'open-label extension study,' meaning all participants will receive the active medicine, bimekizumab. There is no placebo group in this specific study.

Who can join this study?

This study is specifically for adults with psoriatic arthritis who have already participated in one of the previous bimekizumab studies (PA0010 or PA0011).