Not recruiting

Study of Bimekizumab for Children and Adolescents with Moderate to Severe Hidradenitis Suppurativa

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is evaluating bimekizumab, which is administered by injection under the skin (subcutaneous administration), in children and adolescents who have reached puberty and have moderate to severe hidradenitis suppurativa. Hidradenitis suppurativa is a chronic skin condition that causes painful, swollen lumps to form under the skin, typically in areas where skin rubs together, such as the armpits, groin, and under the breasts. These lumps can break open, releasing fluid and potentially becoming infected.

The purpose of this study is to learn how bimekizumab works in the body (its pharmacokinetics) and assess its safety in young patients with this skin condition. Participants will receive the study medication over a treatment period, during which researchers will monitor how the drug moves through the body and collect information about any side effects that occur.

Throughout the study, researchers will measure the concentration of bimekizumab in participants' blood, track any adverse events, monitor vital signs including blood pressure and pulse, and perform laboratory tests to assess the overall safety of the treatment. They will also check for the development of antibodies against the medication, which can sometimes occur when receiving biological treatments.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study Introduction
You are joining a study to evaluate a medicine called bimekizumab for treating moderate to severe hidradenitis suppurativa (HS). HS is a skin condition that causes painful bumps to form under the skin, typically in areas where skin rubs together.
This study focuses specifically on how the medication works in the bodies of children and adolescents who have reached puberty and have moderate to severe HS.
Step 2
Initial Treatment Period
During the study, you will receive bimekizumab through subcutaneous injections (injections under the skin).
The study will track how the medication moves through your body (called pharmacokinetics) and how safe it is for you.
This initial treatment period will last for 16 weeks, during which you will receive regular doses of the study medication.
Step 3
Study Visits and Monitoring
Throughout the study, you will attend regular clinic visits where healthcare professionals will:
Monitor your HS symptoms and check how your skin is responding to the treatment
Take blood samples to measure the amount of bimekizumab in your system
Check your vital signs including blood pressure and pulse
Perform laboratory tests to monitor your overall health
Ask about any side effects or problems you might be experiencing
Step 4
Safety Assessments
Your safety will be closely monitored throughout the study. This includes checking for:
Any side effects that might occur during treatment
Changes in blood pressure or pulse
Changes in blood test results
Injection site reactions (like redness or swelling where the medication was injected)
Signs of infections or other health concerns
Step 5
Antibody Testing
During the study, blood tests will check if your body is developing antibodies against bimekizumab. This is a normal process to monitor as part of the study.
Step 6
Study Completion
After completing the 16-week initial treatment period, you may be evaluated for the final assessment of how the medication worked for you.
The study is expected to run until 2025, though your individual participation may be shorter.

Who can join the trial?

6 criteria

You must be between 12 and under 18 years old when you sign the consent form, and be at Tanner stage 2 or higher (a scale that measures physical development during puberty) for the first 8 participants; later, the study will also include children from 9 to under 18 years old at Tanner stage 2 or higher.
You must have been diagnosed with Hidradenitis Suppurativa (a chronic skin condition that causes painful lumps under the skin) for at least 6 months before starting the study.
You must have moderate to severe Hidradenitis Suppurativa, with at least 5 inflammatory lesions (painful bumps and abscesses) in total at both screening and baseline visits.
Your Hidradenitis Suppurativa lesions must be present in at least 2 different body areas, with at least one area being Hurley Stage II or III (moderate to severe stages of the condition) at both screening and baseline visits.
You must have tried systemic antibiotics (antibiotics that work throughout the body) for Hidradenitis Suppurativa in the past and not had adequate improvement.
You must weigh at least 30kg (about 66 pounds) at the screening visit.

Who cannot join the trial?

9 criteria

You cannot participate if you have any condition that would put your safety at risk or interfere with the study assessments as determined by the study doctor.
You cannot participate if you have active tuberculosis (an infectious disease that mainly affects the lungs) or signs of tuberculosis on chest X-ray.
You cannot participate if you have a known hypersensitivity (severe allergic reaction) to any ingredient in the study medication.
You cannot participate if you have a history of suicidal behavior (attempting to take your own life) or major psychiatric disorders (serious mental health conditions).
You cannot participate if you have active viral hepatitis (liver inflammation) or HIV (human immunodeficiency virus) infection.
You cannot participate if you have active or chronic infections requiring treatment with antibiotics, antivirals or antifungals (medications that fight bacteria, viruses, or fungi).
You cannot participate if you have received certain medications like biologics (medications made from living organisms) within specified timeframes before the study.
You cannot participate if you are pregnant, breastfeeding, or planning to become pregnant during the study or within a specified time after the last dose of study medication.
You cannot participate if you have participated in another clinical study involving an investigational drug within 30 days or 5 half-lives of that drug before this study.

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Verified sites

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Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Verified
Mainz, Germany
Dermedic Jacek Zdybski
Verified
Ostrowiec Swietokrzyski, Poland

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Investigated drugs

Bimekizumab is a medication that works by blocking specific proteins in the body called IL-17A and IL-17F that contribute to inflammation. It is administered by an injection under the skin (subcutaneous injection). In this study, it's being investigated for treating hidradenitis suppurativa, which is a chronic skin condition that causes painful, swollen lumps under the skin.

Bimekizumab

What is already known about the treatment

Bimekizumab - A medication administered via subcutaneous injection (under the skin) that is currently in clinical trials for treating moderate to severe hidradenitis suppurativa in pubertal children and adolescents. Bimekizumab works by selectively targeting and inhibiting both interleukin-17A and interleukin-17F, two inflammatory cytokines that play a key role in the inflammation associated with hidradenitis suppurativa. It belongs to the class of biologic drugs known as monoclonal antibodies and has shown promising results in treating inflammatory conditions, with existing approvals for certain forms of psoriasis in adults, while its use in younger populations with hidradenitis suppurativa is still being investigated for safety and effectiveness.

Investigated diseases

Hidradenitis Suppurativa – A chronic inflammatory skin condition characterized by painful nodules, abscesses, and tunnels (sinus tracts) that typically affect areas with hair follicles and sweat glands, such as the armpits, groin, buttocks, and under the breasts. The condition begins with the blockage of hair follicles, leading to inflammation and the formation of painful bumps that can rupture, releasing pus and creating deeper infections. Over time, recurrent episodes can cause scarring and the development of sinus tracts beneath the skin. Hidradenitis suppurativa usually first appears after puberty and may worsen with hormonal changes, often following a chronic course with periods of flare-ups and relative calm.