All studies
Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis

This research is looking into a new medicine, bimekizumab, for adults living with active psoriatic arthritis. Psoriatic arthritis causes joint pain and swelling, often alongside skin problems. The study aims to find out if bimekizumab is effective and safe. Participants will receive either bimekizumab, another established medicine called risankizumab, or a placebo (a treatment with no active medicine). Researchers will compare how these treatments work after 16 weeks. This study is important because it could lead to new treatment options for people who haven't found enough relief from current therapies.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
UCB Biopharma SRL
Enrolment target
684
Start
21 Oct 2024
Estimated completion
05 Jun 2026

What is this study about?

This study is about finding better ways to treat psoriatic arthritis in adults. Psoriatic arthritis is a type of arthritis that can cause pain, stiffness, and swelling in your joints, and it's often linked to psoriasis, a skin condition. Many people with psoriatic arthritis already take medicines, but sometimes these don't work well enough, or they cause side effects.

The main goal of this study is to compare a new medicine called bimekizumab with another medicine, risankizumab, and a placebo (a 'dummy' treatment). By comparing them, doctors can see if bimekizumab is effective in reducing symptoms like joint pain and swelling, and if it's safe to use. The study will look closely at how participants respond after 16 weeks of treatment.

Finding new and effective treatments is really important for people living with psoriatic arthritis. It could offer more choices and improve their quality of life, helping them to manage their symptoms better and feel more comfortable. This research helps us understand if bimekizumab could be one of those new options.

Key takeaways

  • This study is for adults with active psoriatic arthritis.
  • It's testing a new medicine, bimekizumab, against an existing one and a placebo.
  • The main goal is to check how well bimekizumab works and if it's safe.
  • You'll have regular check-ups and follow-ups over at least 16 weeks.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you generally need to be an adult diagnosed with psoriatic arthritis for at least six months. Your psoriatic arthritis should still be active, meaning you have tender and swollen joints, even if you've already tried some other arthritis medications. You also need to have at least one active psoriasis skin patch or a history of plaque psoriasis.

You might be able to join if you're currently taking certain arthritis medicines or if you've tried at least one of them (like methotrexate, leflunomide, or sulfasalazine) but it didn't work well enough or caused problems. If you've previously used a certain type of arthritis medicine called a TNF inhibitor, you might still be eligible, provided you only tried one, and it either didn't work or you had a bad reaction to it.

However, some things would prevent you from taking part. For example, if you have another significant medical or mental health condition that might interfere with the study, or if you have an active infection, you wouldn't be able to join. Also, women who are pregnant, breastfeeding, or planning to become pregnant during the study period cannot participate.

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 an adult (18 years or older)?
  2. Have you been diagnosed with psoriatic arthritis for at least 6 months?
  3. Do you still have active joint pain and swelling despite your current or past treatments?
  4. Do you have psoriasis or a history of it?
  5. Have you used one or fewer TNF inhibitor medicines before?
  6. Are you not pregnant, breastfeeding, or planning to become pregnant?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of three groups: receiving bimekizumab, risankizumab, or a placebo. You won't know which one you're getting, and neither will the study doctors, to keep the results fair. You'll have regular hospital visits for check-ups, where doctors will assess your joints and skin, take blood samples, and ask about your symptoms and how you're feeling. You'll receive the study medication, likely as injections, which will be given by a healthcare professional or you might be taught how to do them yourself.

The initial treatment phase where the main comparison happens lasts for 16 weeks. After that, there might be options to continue on the study medication for a longer period, and there will be follow-up appointments to monitor your health. The medical team will explain the full schedule of visits and procedures if you are interested in joining. The total time you'd be involved in the study would be discussed with you.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as gaining access to a new treatment for your psoriatic arthritis that might improve your symptoms, and you'll receive close medical monitoring throughout the study. However, there are also potential risks; the study medicines might have side effects that aren't fully known, or they might not work for you. The placebo group won't receive active treatment, so their psoriatic arthritis symptoms might not improve during this time. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (127)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Pa0016 50662
    Verified postcode
    Gilbert, United States
  • Pa0016 50062
    Verified postcode
    Glendale, United States
  • Pa0016 50058
    Verified postcode
    Phoenix, United States
  • Pa0016 50131
    Verified postcode
    Sun City, United States
  • Pa0016 50654
    Verified postcode
    Covina, United States
  • Pa0016 50663
    Verified postcode
    San Diego, United States
  • Pa0016 50672
    Verified postcode
    Santa Monica, United States
  • Pa0016 50630
    Verified postcode
    Clearwater, United States
  • Pa0016 50679
    Verified postcode
    Cutler Bay, United States
  • Pa0016 50685
    Verified postcode
    Fort Lauderdale, United States
  • Pa0016 50059
    Verified postcode
    Ormond Beach, United States
  • Pa0016 50324
    Verified postcode
    Plantation, United States

Common questions

What is psoriatic arthritis?

Psoriatic arthritis is a type of arthritis that affects some people who have psoriasis. It causes joint pain, stiffness, and swelling, and can also affect your nails and skin.

What is bimekizumab?

Bimekizumab is a new medicine being tested in this study to see if it can help treat the symptoms of psoriatic arthritis.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks like the real medicine but contains no active ingredients. It helps doctors see if the other medicines are genuinely working better than no treatment at all.

Will I know if I'm getting the real medicine or the placebo?

No, during the main part of the study, neither you nor your doctors will know which treatment you are receiving. This is called 'blinding' and helps ensure the results are accurate.

What if I feel unwell during the study?

The study team will monitor you closely. If you feel unwell or have any concerns, you should tell them immediately. You can leave the study at any time if you wish.

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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