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Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Open-Label, Parallel Group, Multicenter, Extension Study Evaluating the Long-Term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

This research is an ongoing study for adults with moderate to severe hidradenitis suppurativa, a long-term skin condition. It aims to gather more information on the long-term treatment with a medicine called bimekizumab. Researchers want to see how safe this medicine is over time by tracking any side effects or problems that might come up. They also want to understand if it continues to help improve the symptoms of HS. This study is building on previous research to give a clearer picture of how bimekizumab works for people living with HS. It will help doctors and patients understand the potential benefits and risks of using this treatment for longer periods, ultimately helping to improve care for people with this condition. Participants will be closely monitored to ensure their well-being throughout the study.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic confirmatory (Phase III)
Sponsor
UCB Biopharma
Enrolment target
347
Start
08 Aug 2024

What is this study about?

This study is a detailed look at a medicine called bimekizumab for treating hidradenitis suppurativa (HS), a chronic skin condition that causes painful lumps and boils. It's called an "extension study" because it follows on from earlier research. Its main goal is to find out how safe bimekizumab is when used for a longer time, and whether it keeps helping people with HS over many months or even years.

The main things the researchers are checking are any new health problems or side effects people experience while taking the medicine. They also want to see how much the HS improves, such as reducing the number of painful lumps. They'll be looking at how the medicine affects daily life and pain levels. This type of study is really important because it helps us understand the long-term effects of a treatment, not just the short-term ones.

By gathering this information, doctors can get a better idea of whether bimekizumab is a good long-term option for people with moderate to severe HS. It helps ensure that any new treatments are not only effective but also safe for people to use over extended periods, offering hope for better management of this challenging condition.

Key takeaways

  • This study evaluates bimekizumab for long-term HS treatment.
  • It's an extension of a previous study, focusing on safety and effectiveness over time.
  • Bimekizumab aims to reduce painful HS symptoms.
  • Participants will have regular health check-ups and symptom assessments.
  • It helps us understand if bimekizumab is a safe and effective long-term option for HS.
  • All health information will be carefully monitored.

Who may be eligible?

To join this study, participants must have been part of an earlier study where they received bimekizumab. This ensures that the researchers are continuing to follow people who are already familiar with the medicine.

Anyone aged 18 years or older can take part, regardless of whether they are male or female. The study is open to both men and women, provided they meet all other criteria.

Essentially, this study is for adult patients with moderate to severe hidradenitis suppurativa who have already been treated with bimekizumab in a previous study and who wish to continue to be monitored.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with moderate to severe hidradenitis suppurativa?
  3. Did you take part in a previous study where you received bimekizumab?
  4. Are you able to attend regular clinic appointments for monitoring?
Answer every question to see your result.

What does participation involve?

Taking part in this study means you'll continue to receive bimekizumab treatment. You will have regular visits to the clinic where the study team will monitor your health very closely. They will check for any side effects, assess how your hidradenitis suppurativa is responding to the treatment, and ask you about your symptoms and how you're feeling. These assessments might include physical exams, questionnaires about your pain and quality of life, and possibly blood tests or other checks. The exact number and frequency of visits, as well as the total length of your participation, will be explained in detail by the study team. Everything will be clearly laid out before you decide to join.

Potential risks and benefits

Participating in this study might offer potential benefits, such as continued access to bimekizumab treatment which could help manage your hidradenitis suppurativa symptoms and improve your quality of life. However, like all medicines, bimekizumab can have side effects, and some might be serious. The study team will carefully monitor you for any health problems or side effects. It's important to remember that joining a study is always your choice, and you have the right to withdraw at any time without giving a reason, and this will not affect your usual medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Germany
  • Unverified
    Ireland
  • Unverified
    Greece
  • Unverified
    Bulgaria
  • Unverified
    Spain
  • Unverified
    France
  • Unverified
    Poland
  • Unverified
    Netherlands
  • Unverified
    Italy

Common questions

What is hidradenitis suppurativa (HS)?

HS is a long-term skin condition that causes painful lumps and abscesses, usually in areas where skin rubs together, like the armpits or groin.

What is bimekizumab?

Bimekizumab is a medicine being studied as a treatment for conditions like HS. It works by targeting specific parts of the immune system.

What does 'extension study' mean?

An 'extension study' means this research is a continuation of an earlier study. It aims to gather more information about the long-term effects of a treatment.

Will I know if I'm getting the actual medicine?

This is an 'open-label' study, which means both you and the study team will know that you are receiving bimekizumab.

What kind of monitoring will happen?

You will have regular check-ups, assessments of your HS, and monitoring for any side effects to ensure your safety and track the treatment's effectiveness.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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