Active not recruitingPHASE3INTERVENTIONAL

A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

This research study is looking into bimekizumab, a medication for moderate to severe hidradenitis suppurativa (HS). It’s designed to check how safe this treatment is when used for a longer time. People taking part have already been in earlier studies (HS0003 or HS0004) where they’ve been receiving bimekizumab. The main aim is to carefully watch how participants respond to the treatment over an extended period. This helps doctors understand its long-term effects and safety profile, which is crucial for conditions like HS that can be ongoing. By getting this information, researchers hope to improve future treatments and care for people living with HS.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

UCB Biopharma SRL

Enrolment target

658

Start

27 May 2021

Estimated completion

28 Jul 2026

Hidradenitis Suppurativa

What is this study about?

This study is all about understanding the long-term safety of a medication named bimekizumab for people who have moderate to severe hidradenitis suppurativa, often called HS. HS is a challenging skin condition that causes painful lumps and abscesses. This particular study is for people who have already been taking bimekizumab in earlier research studies (called HS0003 or HS0004) and are continuing their treatment.

The main goal is to keep a close eye on these participants over a longer period. While the previous studies looked at how well bimekizumab worked, this study focuses on understanding its safety when used for an extended time. This is really important because some treatments might have different effects, or side effects, when used over many months or years compared to just a few weeks.

By carefully tracking participants' health and any changes, the researchers hope to build a complete picture of bimekizumab's long-term safety. This information will help doctors know more about how to use this medication safely and effectively in the future, ultimately benefiting people in the UK and worldwide who live with HS.

Key takeaways

This study evaluates the long-term safety of bimekizumab for moderate to severe HS.
It is for participants who were already in previous bimekizumab studies (HS0003 or HS0004).
Participation involves continuing existing treatment and regular health check-ups.
The goal is to understand how bimekizumab affects health over an extended period.
Women of childbearing potential need to use reliable contraception.

Who may be eligible?

To join this study, participants must have already completed one of the previous bimekizumab studies (HS0003 or HS0004) for hidradenitis suppurativa. They must have finished the treatment up to Week 48 in that earlier study and have been suitable to continue with bimekizumab at the end of it. The doctors running the study will also need to be confident that you can understand what's involved and follow the study instructions, including attending appointments and taking medication as prescribed.

For women, you can take part if you are not pregnant and not breastfeeding. If you are able to have children, you must agree to use reliable contraception throughout the study and for at least 20 weeks after your last dose of the study medication. If you are unable to get pregnant (for example, if you have gone through menopause or had a hysterectomy), these contraception rules do not apply.

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.

Did I complete the earlier Bimekizumab study (HS0003 or HS0004) to Week 48?
Was I eligible to continue bimekizumab at the end of that previous study?
Am I able to understand and follow study instructions, appointments, and medication plans?
If I am a woman, am I not pregnant or breastfeeding, and willing to use contraception if able to have children?

Answer every question to see your result.

What does participation involve?

Taking part in this study primarily involves continuing your bimekizumab treatment that you started in an earlier study. You will have regular visits to the clinic so the study team can monitor your health and how you're responding to the medication. These visits will also involve completing questionnaires about your health and how you feel. The total duration of your participation will depend on the study schedule, but it's focused on long-term follow-up from your previous trial participation.

Potential risks and benefits

Like all medical studies, there are potential benefits and potential risks. The main benefit is continued access to a treatment that may be helping your hidradenitis suppurativa, with close medical monitoring. Potential risks could include side effects from bimekizumab, which would be monitored carefully by the study team. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (145)

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

Hs0005 50140
Verified postcode
Birmingham, United States
Hs0005 50175
Verified postcode
Phoenix, United States
Hs0005 50162
Verified postcode
Fountain Valley, United States
Hs0005 50161
Verified postcode
Los Angeles, United States
Hs0005 50220
Verified postcode
San Diego, United States
Hs0005 50196
Verified postcode
Thousand Oaks, United States
Hs0005 50199
Verified postcode
Miami, United States
Hs0005 50205
Verified postcode
North Miami Beach, United States
Hs0005 50152
Verified postcode
Orange Park, United States
Hs0005 50184
Verified postcode
Pembroke Pines, United States
Hs0005 50193
Verified postcode
Sandy Springs, United States
Hs0005 50280
Verified postcode
Watkinsville, United States

Common questions

What is hidradenitis suppurativa?

Hidradenitis suppurativa (HS) is a chronic, painful skin condition that causes lumps, abscesses, and scars, usually in areas where skin rubs together, like the armpits or groin.

What is bimekizumab?

Bimekizumab is a medication being studied as a treatment for conditions like hidradenitis suppurativa. It works by targeting specific parts of the body's immune system.

Why is long-term safety important?

Understanding long-term safety is crucial for medicines treating ongoing conditions, as side effects or how the medicine works can sometimes change over extended periods. This helps doctors use it safely in the future.

Do I get paid for taking part?

The study information does not mention payment for participation; however, typically, travel expenses related to visits might be covered. You should confirm this with the study team.

Who can I contact if I have more questions?

If you are interested in this study and meet the general criteria, you should speak to the research team involved in your previous bimekizumab study (HS0003 or HS0004).