Study on the Safety and Body Processing of Bimekizumab in Children with Juvenile Idiopathic Arthritis

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What is this study about?

This clinical trial is focused on studying certain types of juvenile idiopathic arthritis, specifically enthesitis-related arthritis (which includes juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis. These are conditions that cause joint inflammation in children and can lead to pain and stiffness. The treatment being studied is a medication called bimekizumab, which is given as a solution for injection under the skin. Bimekizumab is also known by its code name, UCB4940.

The purpose of this study is to learn if bimekizumab is safe and how it moves throughout the body in children with these types of arthritis. The study will involve children aged 2 to less than 18 years who have active disease. Participants will receive bimekizumab injections and will be monitored over a period of time to see how the medication affects them. The study will also look at any side effects that may occur and how the children’s health changes during the study.

Throughout the study, researchers will measure the levels of bimekizumab in the blood and observe any changes in the participants’ health, including their growth and vital signs like blood pressure and heart rate. The study will also assess any reactions at the injection site and monitor for any serious side effects, such as infections or other health issues. This information will help determine the safety and effectiveness of bimekizumab for treating these types of juvenile arthritis in children.

1 initial treatment period

Upon joining the study, you will begin the initial treatment period. During this time, you will receive the medication called bimekizumab. This medication is given as a solution for injection under the skin, known as subcutaneous use.

The purpose of this period is to evaluate how the medication moves through your body and to monitor its safety. You will receive regular injections and attend scheduled visits to assess your health and response to the treatment.

2 medication administration

You will receive bimekizumab injections at specific intervals. The exact dosage and frequency will be determined by the study team based on your individual needs and the study protocol.

It is important to attend all scheduled appointments to ensure the medication is administered correctly and to monitor any potential side effects.

3 monitoring and assessments

Throughout the study, your health will be closely monitored. This includes regular assessments of your vital signs, such as blood pressure and heart rate, as well as laboratory tests to check your blood chemistry and hematology.

Your growth, including height and weight, will also be measured to ensure the treatment is not affecting your development.

4 safety evaluations

The study will track any treatment-emergent adverse events, which are any new or worsening health issues that occur during the study. Serious events and those leading to discontinuation of the medication will be carefully documented.

Special attention will be given to certain safety events, such as infections or reactions at the injection site, to ensure your well-being.

5 response to treatment

Your response to the treatment will be evaluated using specific criteria, such as the American College of Rheumatology pediatric response and the Juvenile Arthritis Disease Activity Score. These assessments help determine how well the medication is working for you.

Changes in your condition from the start of the study will be measured at various points, including at week 16, to assess the effectiveness of the treatment.

6 antibody detection

Before and after receiving the medication, tests will be conducted to detect any antibodies your body may produce in response to bimekizumab. This helps understand how your immune system is reacting to the treatment.

The presence of antibodies can influence the effectiveness of the medication, so it is important to monitor this aspect throughout the study.

Who Can Join the Study?

Participant must be between 2 and 17 years old at the start of the study.
Participant or their parent/legal representative must be able to provide signed consent to join the study.
Participant must have a confirmed diagnosis of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) or juvenile psoriatic arthritis for at least 6 months before the study begins.
Participant must have active disease, meaning at least 3 active joints and, for enthesitis-related arthritis, at least 1 site of enthesitis (inflammation where tendons or ligaments attach to bone) at the start of the study or documented in their medical history.
Participant must have had an inadequate response or intolerance to at least one nonsteroidal anti-inflammatory drug (NSAID) for at least 1 month.
Participant can continue taking methotrexate or sulfasalazine if they have been on a stable dose for the past 4 weeks and plan to keep the same dose for the first 16 weeks of the study. However, taking these medications is not required to join the study.
Participant must not be using other second-line treatments like disease-modifying or immunosuppressive drugs, except for methotrexate or sulfasalazine.
Participant must weigh at least 10 kg (about 22 pounds).
Both male and female participants are eligible.
Female participants must not be pregnant or breastfeeding. If they are of childbearing potential, they must agree to use contraception during the study and for at least 20 weeks after the last dose of the study medication.

Who Cannot Join the Study?

Patients with any other active autoimmune disease, which means a condition where the immune system attacks the body.
Patients who have had a serious infection in the past 3 months.
Patients who have received any live vaccine within 4 weeks before the study starts. A live vaccine is a type of vaccine that uses a weakened form of the germ that causes a disease.
Patients with a history of cancer, except for certain types of skin cancer that have been treated.
Patients who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse in the past year.
Patients who have participated in another clinical trial within the last 30 days.
Patients with known allergies to the study medication or its ingredients.
Patients with any condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hopital Necker Enfants Malades	Paris	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Wojewodzki Specjalistyczny Szpital Dzieciecy Im Sw Ludwika W Krakowie	Cracow	Poland
Asklepios Klinik Sankt Augustin GmbH	Sankt Augustin	Germany
HELIOS Klinikum Berlin-Buch GmbH	Berlin	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
St.-Josef-Stift	Sendenhorst	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.	Sosnowiec	Poland
Hifnmqkzj Zirbvfz fphi Knrfnvu uvu Jgtiokpkbaascbwoyqa	Hamburg	Germany
Cnuqrz Hrccrjgxqqa Rlutydiu Ulkmixpghojgw Dr Tgmld	Tours	France
Ceq Kducjrd Bpdkwdo	Le Kremlin-Bicetre	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	15.11.2024
Germany	Recruiting	15.11.2024
Poland	Recruiting	15.11.2024
Spain	Recruiting	15.11.2024

Trial locations

Investigated drugs:

Bimekizumab

Bimekizumab is a medication being studied for its effects on children and teenagers with certain types of arthritis, specifically juvenile idiopathic arthritis. This condition causes joint pain and swelling. Bimekizumab works by targeting specific proteins in the body that are involved in causing inflammation. By blocking these proteins, the medication aims to reduce the symptoms of arthritis, such as pain and swelling, and improve the overall quality of life for the patients. In this trial, the medication is given as an injection under the skin, and researchers are studying how the body processes the medication and how safe it is for young patients.

Investigated diseases:

Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis Subtype – This form of arthritis occurs in children and is characterized by inflammation where tendons or ligaments attach to bone, known as enthesitis. It often affects the joints of the lower limbs and the spine. The disease can cause pain, swelling, and stiffness in the affected areas. Over time, it may lead to reduced mobility and joint damage. Symptoms can vary in intensity and may come and go. The condition is chronic and can persist into adulthood.

Juvenile Psoriatic Arthritis – This type of arthritis affects children and is associated with psoriasis, a skin condition that causes red, scaly patches. It involves joint inflammation, leading to pain, swelling, and stiffness. The disease can affect any joint, but commonly involves the fingers and toes, causing them to swell. Over time, it may result in joint damage and reduced function. Symptoms can fluctuate, with periods of increased activity and remission. The condition is chronic and can continue into adulthood.

Trial ID:

2023-508845-41-00

Protocol code:

JA0005

NCT ID:

NCT06668181

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Body Processing of Bimekizumab in Children with Juvenile Idiopathic Arthritis

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