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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
ASST Fatebenefratelli Sacco Milan Italy
Universitaetsklinikum Aachen AöR Aachen Germany
Centre Hospitalier Regional De La Citadelle Liege Belgium
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi Ancona Italy
Children’s Hospital Zagreb Zagreb Croatia
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo Trieste Italy
Athens General Children’s Hospital Panagioti And Aglaia Kyriakou Athens Greece
Hippokration Hospital Athens Greece
KBC Zagreb Zagreb Croatia
Clinical Medical Center Osijek Osijek Croatia
Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara Timisoara Romania
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Instytut Pomnik Centrum Zdrowia Dziecka Warsaw Poland
Hospital Femme Mere Enfant Bron France
Centre Hospitalier Universitaire De Montpellier Montpellier France
In Vivo Sp. z o.o. Bydgoszcz Poland
Centre Hospitalier Universitaire De Rennes Rennes France
University Childrens Hospital Queen Fabiola Brussels Belgium
Unidade Local De Saude Do Alto Minho E.P.E. Ponte De Lima Portugal
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Sykehuset I Vestfold HF Tonsberg Norway
Children’s Health Ireland Dublin Ireland
Groupement Des Hopitaux De L’Institut Catholique De Lille lomme France
Universitaetsklinikum Leipzig AöR Leipzig Germany
MD Korczowski Bartosz Gabinet Lekarski Rzeszow Poland
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Cvnwaf Hpkkbrmrvvl Uuqewpgxlhpkr Dc Djgcd Dijon France
Cryfqr Htrmzzfnvet Rmhcofzg Ugushwqbsthjd Du Tdptm Tours France
Aqxwiwa Ogdanvjscey Nfokzapah Sb Ajdctuj E Bpjmqv E C Abtram Anaodqelsvh Alexandria Italy
Uacvbsdjnr Dhyad Sqmea Dp Rvrr Lk Spmiyuaj Rome Italy
Hgabsriu Uwrejbczlctgl Hcshvhii Tpugd y Pynodl Ilrdcnaa Clkdwq dplllzlnioehmzthv (syuz Badalona Spain
Cfzxbd Hyevxmuehu E Uebzuwoeiwdle Do Czbvmph Encyap Coimbra Portugal

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.11.2024
Croatia Croatia
Recruiting
01.11.2024
France France
Recruiting
01.11.2024
Germany Germany
Recruiting
01.11.2024
Greece Greece
Recruiting
01.11.2024
Ireland Ireland
Not yet recruiting
01.11.2024
Italy Italy
Recruiting
01.11.2024
Norway Norway
Recruiting
01.11.2024
Poland Poland
Recruiting
01.11.2024
Portugal Portugal
Recruiting
01.11.2024
Romania Romania
Recruiting
01.11.2024
Spain Spain
Recruiting
01.11.2024

Trial locations

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.

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 ID:
2024-511458-32-00
Protocol code:
GLPG0634-CL-331
Trial Phase:
Therapeutic confirmatory (Phase III)

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