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A study to evaluate the safety and effectiveness of filgotinib in children and adolescents aged 8 to 17 years with polyarticular 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 study focuses on polyarticular-course juvenile idiopathic arthritis, a type of chronic joint inflammation that affects multiple joints in children and adolescents. The research aims to evaluate the safety and effectiveness of the drug filgotinib, which is also referred to by the code name GLPG0634. This medication is administered as an oral use treatment in the form of film-coated tablets.

The study will monitor how the body processes the medication, a process known as pharmacokinetics. It will also look at how well the drug works to reduce symptoms and whether it causes any side effects. During the course of the study, participants will be observed over several weeks to track changes in their condition and any potential reactions to the treatment.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment phase

    The filgotinib medication is taken by oral use (swallowing tablets).

    The specific dose of filgotinib, provided as either 100 mg or 200 mg film-coated tablets, is administered to manage polyarticular-course juvenile idiopathic arthritis, which is a type of chronic joint inflammation in children and adolescents.

    The safety and tolerability, which refers to how well the body handles the medicine and whether any side effects occur, are monitored throughout the duration of the study and up to approximately week 22.

  2. Step 2

    Evaluation of progress

    Medical assessments are conducted at week 12 and week 18 to measure the efficacy, or how well the medicine works, against the condition.

    The disease activity is tracked using specific scores and blood tests that measure erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), which are indicators of inflammation (swelling and redness) in the body.

    The incidence of uveitis, which is inflammation inside the eye, is monitored at various timepoints.

    The pharmacokinetics, which describes how the body absorbs, distributes, and processes the medicine, are measured by looking at the concentration of filgotinib and its main byproduct in the blood.

  3. Step 3

    Medication acceptability

    The acceptability of the pediatric formulation (medicine made specifically for children) and the adult film-coated tablet is assessed using a questionnaire to understand how easy the tablets are to take.

Who can join the trial?

6 criteria

  • The person participating or their parent/guardian must agree to follow all the study rules and sign the informed consent form, which is a document that explains everything about the study before it begins.
  • The participant must be between 8 and 17 years old at the time they sign the study documents.
  • The person must have a specific type of juvenile idiopathic arthritis, which is a type of long-term joint inflammation that starts in childhood, and their symptoms must be moderate to severe.
  • The disease must not be well-managed with their current treatment, specifically in categories such as oligoarthritis (affecting a few joints), polyarthritis (affecting many joints), psoriatic arthritis (joint inflammation related to a skin condition), or enthesitis-related arthritis (inflammation where tendons or ligaments meet bone).
  • The participant must have either not responded well to or could not tolerate at least one type of medicine used for this condition for at least 3 months. This includes csDMARDs (standard medicines that help slow down the disease), bDMARDS (advanced medicines that target specific parts of the immune system), or non-steroidal anti-inflammatory drugs (medicines used to reduce pain and swelling).
  • Females who are able to become pregnant and are sexually active must agree to use contraception, which are methods used to prevent pregnancy, as explained in the study rules.

Who cannot join the trial?

9 criteria

  • People who weigh less than 15 kg (about 33 pounds).
  • People with oligoarthritis, which is a type of arthritis that affects 4 or fewer joints.
  • People with undifferentiated arthritis, which means the type of arthritis cannot be clearly categorized into a specific group.
  • People who have had anterior uveitis, which is inflammation inside the front part of the eye, that was active or not controlled within the last 12 weeks.
  • People with systemic JIA, a severe form of juvenile arthritis that affects the whole body and often includes fever and rashes.
  • People with any other rheumatic disease (conditions affecting joints and muscles), inflammatory disease (conditions involving swelling), or immunologic disease (conditions where the immune system is not working correctly). This includes inflammatory bowel disease (problems with the digestive tract), hypogammaglobulinemia (low levels of certain proteins in the blood that help fight infection), or systemic lupus erythematosus (an autoimmune disease where the body attacks its own tissues).
  • People who have an active infection.
  • People who have a history of a complicated herpes zoster infection (commonly known as shingles) that spread to multiple areas of the skin, affected the eyes, or affected the central nervous system (the brain and spinal cord).
  • People who have any other health condition or laboratory abnormalities (unusual results from blood or urine tests) that the doctor believes might prevent them from finishing the study or following the rules of the study.
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Investigated drugs

Filgotinib is a medication taken by mouth that is being studied to see how safe and effective it is for children and teenagers with a type of juvenile arthritis. It works by targeting specific parts of the immune system to help manage the condition.

What is already known about the treatment

Filgotinib - This medication is taken as a pill by mouth and is currently being studied for its ability to treat children and adolescents with certain types of joint inflammation. It belongs to a group of drugs called JAK inhibitors, which work by blocking specific proteins inside cells that trigger the body's inflammatory response. By stopping these signals at a molecular level, the medicine helps reduce swelling and pain in the joints.

Investigated diseases

Polyarticular juvenile idiopathic arthritis - This is a type of chronic inflammation that affects children and adolescents. It is characterized by the involvement of five or more joints. The condition often causes swelling, pain, and stiffness in the affected areas. As it progresses, the inflammation can lead to persistent discomfort and changes in joint movement. It is considered one of the more widespread forms of juvenile arthritis.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-511593-70-00Protocol codeGLPG0634-CL-329Estimated enrolment65 patientsSponsorAlfasigma S.p.A.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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