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Study on the Effects of Filgotinib for Children and Teenagers with Moderate to Severe Ulcerative Colitis

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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 the effects of a medication called filgotinib in children and teenagers who have a condition known as ulcerative colitis. Ulcerative colitis is a disease that causes inflammation and sores in the lining of the large intestine, which can lead to symptoms like abdominal pain and diarrhea. The medication being tested, filgotinib, is taken orally in the form of film-coated tablets or mini-tablets. In this study, the medication is also referred to by its code name, GLPG0634.

The purpose of the study is to evaluate how effective filgotinib is in helping children and teenagers achieve and maintain remission, which means reducing or eliminating the symptoms of ulcerative colitis. The study will involve participants taking the medication over a period of time, with regular check-ups to monitor their health and any changes in their condition. Some participants may receive a placebo, which is a tablet that looks like the medication but does not contain the active substance.

Throughout the study, researchers will assess various aspects of the participants' health, including any side effects they may experience and changes in their growth and development. The study aims to gather information on how well filgotinib works in young people with ulcerative colitis and how safe it is for them to use. The study is expected to continue until 2027, with the recruitment of participants starting in 2024.

The research process

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

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying age, weight, and medical history related to ulcerative colitis.

    The assessment will ensure that the condition has been present for at least three months and that previous treatments have not been effective.

  2. Step 2

    Induction phase

    During the induction phase, you will begin taking Jyseleca tablets orally. The dosage will be determined by the study team based on your specific needs.

    This phase lasts for 10 weeks, during which the effectiveness of the medication in reducing symptoms will be evaluated.

  3. Step 3

    Maintenance phase

    If the medication is effective, you will continue to the maintenance phase, which lasts until week 58.

    The goal is to maintain symptom reduction and monitor any changes in your condition.

  4. Step 4

    Regular check-ups

    Throughout the trial, regular check-ups will be scheduled to monitor your health and the effects of the medication.

    These check-ups will include physical examinations, blood tests, and questionnaires about your symptoms and overall well-being.

  5. Step 5

    End of trial

    At the end of the trial, a final assessment will be conducted to evaluate the overall impact of the treatment.

    You will be asked to provide feedback on your experience and any changes in your condition.

Who can join the trial?

8 criteria

  • The patient must weigh at least 15 kilograms (about 33 pounds).
  • The patient must have a documented diagnosis of ulcerative colitis for at least 3 months.
  • The patient must have a modified Mayo Clinic Score (mMCS) between 5 and 9. This is a score used to measure the severity of ulcerative colitis.
  • The patient must have an endoscopic score of 2 or higher. This score is based on a test that looks inside the colon to check for inflammation.
  • The patient must have a rectal bleeding score of 1 or higher. This score measures the amount of bleeding from the rectum.
  • The patient must have a stool frequency score of 1 or higher. This score measures how often the patient has bowel movements.
  • The patient must have had an inadequate response, loss of response, intolerance, or medical reasons not to use corticosteroids, immunosuppressants, or biologic therapy. This includes patients who rely on corticosteroids to manage symptoms but experience worsening of their condition when trying to reduce or stop corticosteroids.
  • The patient must be a female or male between 8 and less than 18 years old at the time of signing the informed consent form.

Who cannot join the trial?

10 criteria

  • Patients with any other significant health condition that could interfere with the study.
  • Patients who have had a recent infection that required treatment with antibiotics or antiviral medications.
  • Patients who have a history of cancer, except for certain types of skin cancer that have been treated.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who are currently participating in another clinical trial.
  • Patients who have received certain medications that could affect the study results.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of certain blood disorders.
  • Patients who have had a recent surgery or are planning to have surgery during the study.
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Investigated drugs

Filgotinib is a medication being studied for its potential to help children and teenagers with ulcerative colitis, a condition that causes inflammation and sores in the colon. This medication works by targeting specific pathways in the immune system that are involved in causing inflammation. The goal of using filgotinib in this trial is to see if it can help reduce the symptoms of ulcerative colitis and maintain this improvement over time. Participants in the trial will receive filgotinib to assess its effectiveness and safety in managing their condition.

What is already known about the treatment

Filgotinib – Filgotinib is administered orally in the form of a tablet. It is currently being studied in clinical trials for its effectiveness and safety in treating children and teenagers with moderately to severely active ulcerative colitis, a condition that causes inflammation and sores in the colon. The medication works by inhibiting a specific enzyme called Janus kinase 1 (JAK1), which plays a role in the inflammatory process, thereby reducing inflammation in the body. Filgotinib is classified as a Janus kinase inhibitor, a type of medication that targets specific pathways involved in inflammation.

Investigated diseases

Ulcerative colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon, also known as the large intestine. It is characterized by continuous inflammation and ulceration of the innermost lining of the colon, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease typically begins in the rectum and may extend to involve the entire colon over time. The inflammation causes the colon to become swollen and develop open sores, or ulcers, which can produce pus and mucus. As the disease progresses, individuals may experience periods of exacerbation and remission, where symptoms worsen and then improve. The exact cause of ulcerative colitis is unknown, but it is believed to involve an abnormal immune response in genetically predisposed individuals.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-511458-32-00Protocol codeGLPG0634-CL-331Estimated enrolment88 patientsSponsorAlfasigma S.p.A.

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