Not recruiting

Study on the Safety, Effectiveness, and Blood Movement of Bimekizumab in Adolescents with Moderate to Severe Plaque Psoriasis

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 clinical trial is focused on studying moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches on the skin. The study is testing a treatment called bimekizumab, which is given as a solution for injection. Bimekizumab is also known by the code name UCB4940. The purpose of the study is to learn about the safety of bimekizumab, how well it works, and how it moves through the bloodstream in adolescents with this type of psoriasis.

Participants in the study will receive bimekizumab through an injection under the skin. The study will follow participants over a period of time to monitor the levels of the medication in their blood at various points, such as weeks 0, 1, 4, 8, 12, and so on, up to week 124. The study will also look at any side effects that may occur and how the participants' psoriasis responds to the treatment.

Throughout the study, changes in participants' health will be observed, including vital signs like blood pressure and heart rate, as well as blood tests to check for any changes in blood cells and chemistry. The study will also assess improvements in the skin condition using specific measures like the Psoriasis Area and Severity Index (PASI) and the Investigator's Global Assessment (IGA). The goal is to gather comprehensive information on how bimekizumab affects adolescents with moderate to severe plaque psoriasis.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of moderate to severe plaque psoriasis, and other health criteria.
The assessment ensures that the participant is a candidate for systemic therapy or photo/chemotherapy and meets the required body weight and body mass index.
Step 2
Treatment initiation
The treatment involves the administration of bimekizumab, a solution for injection given subcutaneously (under the skin).
The first dose is administered at the start of the trial, referred to as Week 0.
Step 3
Regular dosing
Subsequent doses of bimekizumab are administered at specific intervals: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 36, Week 40, Week 64, Week 88, Week 112, and Week 124.
The frequency and timing of doses are designed to assess how the medication moves through the bloodstream and its effects on the condition.
Step 4
Monitoring and assessments
Throughout the trial, regular monitoring is conducted to evaluate the plasma concentration of bimekizumab at each dosing interval.
Additional assessments include monitoring for any adverse events, changes in vital signs, and physical examination findings.
Step 5
Evaluation of treatment response
The effectiveness of the treatment is evaluated using measures such as the Psoriasis Area and Severity Index (PASI) and the Investigator's Global Assessment (IGA).
Responses are assessed at various points, including Week 4 and Week 16, to determine improvements in the condition.
Step 6
Safety follow-up
A safety follow-up is conducted after the final dose to monitor any long-term effects and ensure participant well-being.
This includes a final assessment of the plasma concentration of bimekizumab and any remaining health concerns.

Who can join the trial?

12 criteria

The participant must be between 12 and 18 years old at the time of signing the consent form.
The participant must have been diagnosed with moderate to severe plaque psoriasis for at least 3 months before the screening visit.
The participant's body surface area (BSA) affected by psoriasis must be 10% or more.
The participant must have an Investigator's Global Assessment (IGA) score of 3 or more on a scale from 0 to 4. This is a way to measure the severity of psoriasis.
The participant must have a Psoriasis Area and Severity Index (PASI) score of 12 or more, or a PASI score of 10 or more with at least one of the following:
- Clinically relevant facial involvement
- Clinically relevant genital involvement
- Clinically relevant hand and foot involvement
- The participant must be a candidate for systemic psoriasis therapy, which means treatment that affects the whole body, and/or photo/chemotherapy.
- The participant must weigh at least 30 kg and have a body mass index (BMI) for age in the 5th percentile or higher at the start of the study.
- Both male and female participants are eligible.
- A female participant can join if she is not pregnant, not breastfeeding, and agrees to use birth control if she can have children.
- The participant or their parent/legal representative must be able to provide signed consent or assent, which means they agree to participate in the study.

Who cannot join the trial?

8 criteria

Patients who do not have moderate to severe plaque psoriasis cannot participate. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin.
Patients who are not in the specified age range for the study cannot participate. The study is for adolescents, which generally means teenagers.
Patients who are not able to receive the medication bimekizumab through an injection under the skin cannot participate. Bimekizumab is a type of medication used to treat psoriasis.
Patients who are not able to follow the study procedures or attend study visits cannot participate.
Patients who have other health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are taking other medications that might interfere with the study cannot participate.
Patients who have a history of allergic reactions to similar medications cannot participate.

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Verified sites

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Verified
Goethe University Frankfurt
Frankfurt, Germany
Responsive
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Rzeszow, Poland

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Investigated drugs

Bimekizumab is a medication being studied for its effects on adolescents with moderate to severe plaque psoriasis. It is administered through an injection under the skin. The trial aims to understand how the body processes this medication, as well as to evaluate its safety and effectiveness in reducing the symptoms of psoriasis in the participants.

Bimekizumab

What is already known about the treatment

Bimekizumab – This medication is administered through subcutaneous injection and is currently being studied in clinical trials for its effectiveness and safety in treating moderate to severe plaque psoriasis, particularly in adolescents. Bimekizumab is not yet widely available in medical practice, as it is still under investigation. It works by targeting specific proteins in the immune system to reduce inflammation and plaque formation on the skin. Bimekizumab is classified as a monoclonal antibody, which is a type of biologic drug designed to interfere with specific pathways involved in the disease process.

Investigated diseases

Moderate to Severe Plaque Psoriasis – This is a chronic skin condition characterized by red, scaly patches that can appear anywhere on the body. The patches, known as plaques, are often itchy and can be painful. The disease occurs when skin cells multiply faster than normal, leading to a buildup of cells on the skin's surface. These plaques can vary in size and may join together to cover large areas. The condition can fluctuate, with periods of improvement and worsening. It is not contagious and can affect individuals of any age, though it commonly begins in adolescence or early adulthood.