A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis

To be considered for this study, participants need to be between 8 and 18 years old and weigh at least 15 kg (about 2 stone 5 pounds). They must have had a diagnosis of ulcerative colitis for at least three months, and their condition needs to be moderately to severely active – meaning their symptoms are bothersome, like frequent bowel movements or bleeding.

It’s important that your child's current UC treatment isn't working well enough, or they've had problems with other treatments like steroids or stronger medicines, or they can't take them for medical reasons. This includes children who rely on steroids to keep their symptoms under control and whose symptoms get worse when they try to reduce the steroid dose.

There are also some reasons why someone might not be able to join. For example, if they have certain other bowel conditions, have an active infection, have had a complicated shingles infection, or are currently taking specific medicines for long-term infections. They also can't have had previous surgery to remove their large intestine, severe psychological problems, or have taken similar types of medicines before. Girls who are pregnant, breastfeeding, or planning to be during the study won't be able to take part.

If you decide to take part, your child will take the study medicine (filgotinib) every day. Most days, they'll take it at home in the morning, with or without food. However, at certain times, specifically at Week 4, Week 10, and Week 22, they'll come to the clinic to take the medicine there in the morning, also with or without food.

Doctors will closely monitor your child's condition throughout the study. If their symptoms haven't improved enough by Week 10, they will continue on the treatment until Week 22. If there's still not enough improvement by Week 22, they may need to stop the study medicine and discuss other treatment options with their doctor. The study aims to make sure they receive a dose of filgotinib that gives their body a similar amount of medicine as adults taking 200 mg daily. The total length of time your child will be in the study will depend on how they respond to the treatment.