RecruitingPHASE3INTERVENTIONAL

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

This study is investigating a new medication called filgotinib for children and teenagers (aged 8 to 18) who have moderate to severe ulcerative colitis. The main goals are to find out if filgotinib is effective in treating their condition, how safe it is, and if their bodies process the medicine similarly to adults. Around 80 young people will take part, including at least 8 children aged 8 to 12. Participants will take the medicine at home daily and also visit the clinic at specific times (weeks 4, 10, and 22) to take the medicine there. These visits will also involve checking their progress and seeing how they are reacting to the treatment.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Alfasigma S.p.A.

Enrolment target

Start

29 Sep 2025

Estimated completion

01 Jun 2028

Ulcerative Colitis

What is this study about?

Ulcerative colitis (UC) is a long-term condition where your large intestine (colon and rectum) becomes inflamed and develops tiny open sores (ulcers). This can cause tummy pain, going to the toilet very often, and blood in your poo. Living with UC can be challenging, especially for children and teenagers.

This study is looking into a new medicine called filgotinib to see if it can help children and teenagers between 8 and 18 years old who have UC that is moderate to severe. It’s a medicine that has already been studied in adults with UC, and now researchers want to understand how it works in younger people. They want to check if it helps reduce symptoms, how safe it is, and if young bodies handle the medicine in a similar way to adults.

Taking part in a study like this helps doctors learn more about new ways to treat conditions like UC. This new information can then help other children and teenagers in the future to manage their symptoms better and improve their quality of life.

Key takeaways

New medicine (filgotinib) for children/teenagers with ulcerative colitis.
Ages 8-18 with moderate to severe symptoms are eligible.
Aims to check effectiveness, safety, and how the body handles the medicine.
Daily home dosing, with clinic visits at weeks 4, 10, and 22.
Participation helps future treatments for UC in young people.
You can withdraw from the study at any time.

Who may be eligible?

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.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged between 8 and 18 years old?
Does your child weigh at least 15 kg (about 2 stone 5 pounds)?
Does your child have a confirmed diagnosis of ulcerative colitis for at least 3 months?
Are your child's ulcerative colitis symptoms currently active (moderate to severe)?
Have other ulcerative colitis treatments (like steroids or stronger medicines) not worked well for your child, or can they not take them?
Is your child able to take part in regular clinic visits and take daily medication?

Answer every question to see your result.

What does participation involve?

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.

Potential risks and benefits

Taking part in a clinical trial might offer the chance to try a new medicine that could help improve your child's ulcerative colitis symptoms when other treatments haven't worked well. However, like all medicines, filgotinib may have side effects, and it's important to understand these fully. The study team will explain all known and potential risks in detail. You and your child are free to withdraw from the study at any time, for any reason, without it affecting their usual medical care.

Locations (51)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Verified postcode
Brussels, Belgium· Not yet recruiting
Centre Hospitalier Regional De La Citadelle
Verified postcode
Liège, Belgium· Recruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Verified postcode
Namur, Belgium· Not yet recruiting
Klinicki Bolnicki Centar Osijek
Verified postcode
Osijek, Croatia· Not yet recruiting
Children's Hospital Zagreb
Verified postcode
Zagreb, Croatia· Recruiting
University Hospital Centre Zagreb
Verified postcode
Zagreb, Croatia· Recruiting
Hospital Femme Mere Enfant
Verified postcode
Bron, France· Recruiting
Centre Hospitalier Universitaire De Dijon
Verified postcode
Dijon, France· Recruiting
Hopital Saint Vincent de Paul - GHICL Lille
Verified postcode
Lille, France· Recruiting
CHU de Montpellier
Verified postcode
Montpellier, France· Recruiting
Centre Hospitalier Universitaire De Rennes
Verified postcode
Rennes, France· Recruiting
Centre Hospitalier Regional Universitaire De Tours
Verified postcode
Tours, France· Recruiting

Common questions

What is filgotinib?

Filgotinib is a new medicine being studied to see if it can help reduce the inflammation and symptoms of ulcerative colitis.

How often will my child take the medicine?

Your child will take the medicine daily, usually at home, but also at the clinic on specific visits at weeks 4, 10, and 22.

What if the medicine doesn't work for my child?

If your child's symptoms don't improve enough by certain points in the study (Week 10 or Week 22), they might stop the study medicine, and their doctor will discuss other treatment plans.

How many children will be in the study?

Around 80 children and teenagers will take part, including at least 8 who are aged between 8 and 12 years old.

Can my child stop the study at any time?

Yes, you and your child can decide to leave the study at any point without it affecting their future medical care.

How to find out more

Vincenzo Teneggi, MD

vincenzo.teneggi@external.alfasigma.com 00800 7878 1345 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.