RecruitingPHASE3INTERVENTIONAL

A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa

This study is investigating a new medicine called Bimekizumab for younger people, specifically children and teenagers aged 9 to 17, who have hidradenitis suppurativa (HS). HS is a chronic skin condition causing painful bumps and boils. Researchers want to understand how Bimekizumab moves through the body of these young patients and how safe it is for them. This is a late-stage study, meaning the medicine has already been through earlier testing. The aim is to see if Bimekizumab could be a new treatment option for young people living with moderate to severe HS.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

UCB Biopharma SRL

Enrolment target

Start

07 Apr 2025

Estimated completion

06 Mar 2029

Hidradenitis Suppurativa

What is this study about?

This study is designed to explore a new medicine called Bimekizumab for children and teenagers who have a skin condition called Hidradenitis Suppurativa (HS). HS causes painful lumps, boils, and sometimes tunnels under the skin, often in areas like the armpits or groin. It can be quite severe, and current treatments don't always work for everyone, especially younger patients.

The main goals of this study are twofold. Firstly, researchers want to understand how Bimekizumab behaves in the bodies of young people – how much medicine gets into the bloodstream, how long it stays there, and how it's handled by the body. This is important to ensure the right dose is given. Secondly, they want to check the safety of Bimekizumab for this age group. They will carefully monitor participants for any side effects or unwanted reactions.

By gathering this information, the study aims to see if Bimekizumab could become a safe and effective new treatment option for young people aged 9 to 17 living with moderate to severe HS. It's a phase 3 study, which means it’s a later stage of research, often done before a medicine can be considered for wider use.

Key takeaways

This study investigates a new medicine (Bimekizumab) for moderate to severe HS.
It's for children and teenagers aged 9-17.
The study will check how safe the medicine is and how it works in the body.
It's a Phase 3 study, meaning it's a late-stage test.
Participation involves regular clinic visits and close monitoring.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for young people aged 9 to 17 years old who have Hidradenitis Suppurativa (HS). To be considered, you must have been diagnosed with HS for at least six months and have moderate to severe HS with at least five inflamed bumps (abscesses or painful lumps). Your HS should affect at least two different body areas, with at least one area being moderately or severely affected (known as Hurley Stage II or III). You also need to weigh at least 30 kilograms (about 4 stone 10 pounds) and have tried a course of antibiotics for your HS that didn't work well enough.

There are also some reasons why you might not be able to join. For example, if you have more than 20 draining tunnels from your HS, or if you've already tried certain biologic medicines (like brodalumab, ixekizumab, or secukinumab) for HS and they didn't help at all. You also can't join if you've been in this study before or have taken Bimekizumab previously. Other reasons include a history of certain bowel conditions (like Inflammatory Bowel Disease), active or untreated tuberculosis, or ongoing serious infections.

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 between 9 and 17 years old?
Have you been diagnosed with HS for at least 6 months?
Do you have moderate to severe HS affecting at least two body areas?
Does your HS include at least 5 active bumps (abscesses or inflamed lumps)?
Have you tried antibiotics for your HS that didn't work well enough?
Do you weigh at least 30 kilograms (around 4 stone 10 pounds)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive doses of Bimekizumab, likely given as an injection under the skin. You will have regular visits to the clinic where the study team will monitor your health, assess your HS, and check for any side effects. This will involve physical examinations, blood tests, and potentially other procedures to see how the medicine is working and how you are feeling. The study will involve a number of visits over a period that isn't fully detailed here, but will be explained to you by the study team. You'll need to follow specific instructions about other medicines you might be taking. The study team will provide all the necessary medication and care related to the trial.

Potential risks and benefits

Taking part in this study could potentially offer some benefits, such as access to a new medicine for your HS that isn't widely available yet, which might help improve your condition. However, there are also potential risks, as with any new medicine. Bimekizumab might cause side effects, which will be carefully explained to you by the study team. They will monitor you closely for any unwanted reactions. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (18)

Hs0006 50175
Verified postcode
Phoenix, United States· Recruiting
Hs0006 50708
Verified postcode
Roseville, United States· Recruiting
Hs0006 50684
Verified postcode
Sacramento, United States· Active not recruiting
Hs0006 50707
Verified postcode
Washington D.C., United States· Recruiting
Hs0006 50199
Verified postcode
Miami, United States· Recruiting
Hs0006 50178
Verified postcode
Clarkston, United States· Recruiting
Hs0006 50710
City only
Fort Gratiot, United States· Recruiting
Hs0006 50711
Verified postcode
Troy, United States· Recruiting
Hs0006 50712
Verified postcode
New York, United States· Recruiting
Hs0006 50706
Verified postcode
Chapel Hill, United States· Recruiting
Hs0006 50202
Verified postcode
Fairborn, United States· Recruiting
Hs0006 50201
Verified postcode
Arlington, United States· Recruiting

Common questions

What is Hidradenitis Suppurativa (HS)?

HS is a long-term skin condition that causes painful, inflamed bumps, boils, and sometimes tunnels to form under the skin, often in places where skin rubs together like armpits or groin.

What is Bimekizumab?

Bimekizumab is a new medication being tested. It's a type of 'biologic' medicine that targets specific parts of the immune system that cause inflammation in conditions like HS.

What does 'Phase 3' mean for a study?

Phase 3 means this is a later stage of testing. The medicine has already been studied for safety and basic effectiveness, and now it's being tested in a larger group of people to confirm its benefits and risks.

Will I have to pay to be in the study?

No, all study-related treatments and assessments are provided free of charge if you qualify and choose to participate.

Can I continue my usual HS treatment while in the study?

Some existing treatments might need to be stopped or changed during the study. The study team will discuss this with you and explain which medications are allowed or not allowed.

How to find out more

UCB Cares

ucbcares@ucb.com +18445992273 Official trial record

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