A study to evaluate the safety and effectiveness of filgotinib in children and adolescents with juvenile idiopathic arthritis.

3 1 1 1

What is this study about?

This study focuses on Juvenile Idiopathic Arthritis, which is a type of chronic arthritis—a condition involving inflammation and swelling of the joints—that affects children and adolescents. The investigation aims to determine the long-term safety and how well the body handles the medication filgotinib, which is also known by the brand name Jyseleca. The treatment is administered as an oral medication, meaning it is taken by mouth in the form of film-coated tablets.

The study is an open-label extension, which means that all participants know which medication they are receiving during this phase. Participants will continue to take the medication over an extended period to monitor for any adverse events, which are unexpected or unpleasant side effects. The research also looks at the occurrence of uveitis, an inflammation that can happen inside the eye, to ensure the treatment is safe for long-term use in young people.

Who Can Join the Study?

  • The person must have finished taking the medicine filgotinib in a previous related study and must have seen an improvement in their condition by the end of that study.
  • The person must be between 8 and 17 years old (not yet 18) at the time they sign the paperwork.
  • The person and their parent or legal guardian must be willing to follow all the rules of the study and must sign informed consent, which is a document explaining the study details, and assent, which is a child’s agreement to participate.
  • Female participants who are capable of becoming pregnant and are sexually active must agree to use contraception, which means using methods like birth control to prevent pregnancy, as explained in the study rules.

Who Cannot Join the Study?

  • You developed a new medical condition during the previous study that would make it unsafe for you to continue taking the medication.
  • You are pregnant.
  • You have an active infection, which is an illness caused by germs like bacteria or viruses, that is serious enough to be noticed by the doctor.
  • You have a known hypersensitivity, which means an allergy or an unusually strong reaction, to any of the ingredients used in the study medicine.
  • You have any other health issues or abnormalities in laboratory parameters, which means your blood tests or other medical tests show results that are not in the normal range, that might make it difficult for you to finish the study or follow the study rules.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hopital Necker Enfants Malades Paris France

Other Sites

Site Name City Country Status
Asklepios Klinik Sankt Augustin GmbH Sankt Augustin Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Klinikum St. Georg gGmbH Leipzig Germany
Bicetre Hospital Le Kremlin-Bicetre France
Hamburger Zentrum für Kinder- und Jugendrheumatologie Hamburg Germany
Centre Hospitalier Universitaire De Montpellier Montpellier France
Czbtcr Hqtqrafbpoh Rwynygqy Uxrghpjwxkvbh De Toxer Tours France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
10.04.2026
Germany Germany
Recruiting
10.04.2026

Trial locations

Investigated drugs:

Filgotinib is an oral medication being studied to see how safe and effective it is for children and teenagers with juvenile idiopathic arthritis. It works by helping to manage the symptoms of this type of arthritis in young patients.

Investigated diseases:

Juvenile idiopathic arthritis – This condition involves chronic inflammation of the joints in children and adolescents. The immune system mistakenly attacks healthy joint tissues, leading to swelling and pain. Over time, the inflammation can cause stiffness and affect the movement of the affected areas. Some forms of this disease may also involve inflammation in other parts of the body, such as the eyes. The symptoms can vary in intensity and may change as the person grows.

Trial ID:
2025-523239-21-00
Protocol code:
GLPG0634-CL-333
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A study to evaluate the safety and effectiveness of filgotinib in children and adolescents aged 8 to 17 years with polyarticular juvenile idiopathic arthritis

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia France Germany Greece +4
  • Study on the Effectiveness and Safety of Deucravacitinib for Children and Teens with Juvenile Psoriatic Arthritis

    Recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Germany Italy Romania Spain