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Study on Filgotinib for Children and Teens with Juvenile Idiopathic Arthritis

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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 a condition known as juvenile idiopathic arthritis, which is a type of arthritis that affects children and teenagers. The study will use a medication called filgotinib, which is available in two forms: Jyseleca 100 mg film-coated tablets and Jyseleca 200 mg film-coated tablets. Additionally, a version of the medication known as GLPG0634 will also be used. The purpose of the study is to understand how the body processes filgotinib in children and teenagers with this type of arthritis.

Participants in the study will take the medication orally, which means they will swallow the tablets. The study will involve multiple doses of the medication, and researchers will monitor how the medication is absorbed and processed in the body. This will help determine the safety and tolerability of filgotinib in young patients. The study will also look at any side effects that may occur and how well the participants accept the tablets.

The study is designed to gather important information about the medication's effects in children and teenagers aged 8 to less than 18 years. By understanding how filgotinib works in younger patients, researchers hope to improve treatment options for those with juvenile idiopathic arthritis. The study will continue until the end of 2024, providing valuable insights into the use of filgotinib for this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, the patient will attend an initial visit. During this visit, the patient will receive detailed information about the study and will be asked to sign an informed consent form. This form confirms the patient's willingness to participate and understanding of the study requirements.
Step 2
Baseline assessments
The patient will undergo baseline assessments to evaluate their current health status. These assessments may include physical examinations, blood tests, and other necessary evaluations to ensure eligibility for the study.
Step 3
Medication administration
The patient will begin taking the study medication, filgotinib, in the form of film-coated tablets. The dosage will be either 100 mg or 200 mg, taken orally. The frequency and duration of administration will be determined by the study protocol and communicated to the patient by the study team.
Step 4
Regular follow-up visits
The patient will attend regular follow-up visits at the study center. These visits are scheduled to monitor the patient's response to the medication and to assess any side effects. Blood samples may be taken to measure the levels of filgotinib in the blood.
Step 5
Completion of study
At the end of the study period, the patient will have a final visit. During this visit, the patient will undergo final assessments to evaluate the overall effects of the medication. The study team will discuss the results and any next steps with the patient.

Who can join the trial?

16 criteria

The child and/or their parent(s) or legal guardian must be able and willing to follow the study requirements and must sign a consent form before any study evaluations.
The child must have a body mass index (BMI) within the 5th to 95th percentiles for their age and gender, according to World Health Organization charts. The child must weigh at least 15 kg.
The child must be able and willing to follow restrictions on previous and current medications as required by the study.
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The child must have one of the following types of juvenile idiopathic arthritis (JIA) and have a moderately to severely active disease that is not well controlled with their current treatment:
- RF-positive polyarthritis
- RF-negative polyarthritis
- Oligoarthritis
- Psoriatic arthritis
- Enthesitis-related arthritis (ERA)
- Systemic JIA (sJIA) with active arthritis, with or without stable systemic features in the last 6 months
- check
  The child must have had an intolerance or inadequate response to at least one of the following medications for JIA, used for at least 12 weeks:
  - Conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)
  - Biologic disease-modifying antirheumatic drugs (bDMARDs), including methotrexate (MTX)
  - Non-steroidal anti-inflammatory drugs for ERA and psoriatic arthritis
  - The child must be between 8 and less than 18 years old at the time of signing the consent form.
  - Female participants who have started menstruating must have a negative pregnancy test.
  - Female participants who could become pregnant and are considered potentially sexually active must agree to use contraception or preventive measures.
  - Female participants who cannot become pregnant must meet specific criteria defined by the study.

Who cannot join the trial?

8 criteria

Patients who have any other serious health conditions that could interfere with the study.
Patients who are currently taking medications that might affect the study results.
Patients who have had a recent infection or illness that could impact their participation.
Patients who have a history of allergic reactions to similar medications.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have a history of substance abuse or alcohol dependency.
Patients who have any condition that the study doctors believe would make it unsafe for them to participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Asklepios Klinik Sankt Augustin GmbH
Sankt Augustin, Germany
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Bicetre Hospital
Le Kremlin-Bicetre, France
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Centre Hospitalier Universitaire Amiens Picardie
Amiens, France

Trial locations

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Investigated drugs

Filgotinib is a medication being studied for its effects on children and adolescents with juvenile idiopathic arthritis, a condition that causes joint inflammation and pain. This medication works by targeting specific pathways in the immune system that are involved in causing inflammation. The goal of the study is to understand how the body processes this medication, as well as to assess its safety and how well it is tolerated by young patients. By doing so, researchers hope to determine if filgotinib can be an effective treatment option for managing symptoms of juvenile idiopathic arthritis.

Filgotinib

What is already known about the treatment

Filgotinib – Filgotinib is administered orally in the form of tablets and is currently being studied for its effectiveness and safety in treating juvenile idiopathic arthritis (JIA) in children and adolescents aged 8 to less than 18 years. This medication is still under investigation, and its use in medicine is being evaluated through clinical trials. Filgotinib works by inhibiting specific enzymes called Janus kinases (JAKs), which play a role in the inflammation process, thereby helping to reduce symptoms of arthritis. It is classified as a JAK inhibitor, a type of medication that targets these enzymes to help manage inflammatory conditions.

Investigated diseases

Juvenile Idiopathic Arthritis – Juvenile idiopathic arthritis is a type of arthritis that occurs in children under the age of 16. It is characterized by persistent joint inflammation, which can lead to swelling, pain, and stiffness. The disease can affect one or multiple joints and may also involve other symptoms such as fever and rash. Over time, the inflammation can cause joint damage and affect growth and development. The exact cause of juvenile idiopathic arthritis is unknown, but it is believed to involve a combination of genetic and environmental factors. The progression of the disease can vary, with periods of remission and flare-ups.