At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Filgotinib (drug)
- How long the study runs
- Study runs about 33 months (dates as stated)
- About the drug or intervention
- Filgotinib — drug: IP will be provided as commercially developed film-coated tablets (100 and 200 mg strength) or reduced-strength (65 mg) age-appropriate film-coated tablets for use in pediatric subjects aged at least 8 years and needs to be taken orally q.d.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at the effects of a medicine called filgotinib in children and teenagers with ulcerative colitis, a long-term condition causing inflammation in the bowel. It is run by the sponsor Alfasigma S.p.A. The registry information does not state the study design, so ask the trial team for details.
Who can take part
- Weighs at least 15 kilograms
- Has had ulcerative colitis diagnosed by a doctor for at least 3 months
- Has active symptoms of ulcerative colitis, shown by certain scores for inflammation seen during an examination of the bowel, rectal bleeding, and how often they pass stool
- Current medicines have not worked well enough, have stopped working, or caused problems — including corticosteroids (medicines that reduce inflammation), immunosuppressants (medicines that calm the immune system), and/or biologic therapy. This also includes children who need corticosteroids to control symptoms or whose condition gets worse when lowering the dose
Who may not be able to
- Has inflammatory bowel disease that doctors cannot clearly classify, inflammation only in the lowest part of the bowel, or a very swollen, dangerous widening of the colon called toxic megacolon
- Has an infection at the time of the study
- Has had a serious case of shingles affecting many areas of skin, spreading widely, affecting the eye, or affecting the brain or nerves
- Is currently having treatment for a long-term infection, such as pneumocystis, cytomegalovirus, herpes simplex, shingles, or atypical mycobacteria
- Has had surgery to remove the bowel (colon) or a large amount of small bowel removed
- Has psychological or thinking difficulties that might make taking part hard
- Has taken a type of medicine called a Janus kinase inhibitor, or one that works in a similar way (for example tofacitinib, baricitinib, or upadacitinib)
- Is pregnant or breastfeeding, or plans to become pregnant or breastfeed during the study
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about study visits, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 8 Years to 18 Years
- Who
- All
- Number of participants
- 80
- Started
- 2025-09-29
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for ulcerative colitis
- • Phase3 - 80 participants
- • The aim of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of filgotinib as a treatment for UC in children and adolescents aged from 8 to less than 18 years
Who can take part?
- • Ages 8 Years to 18 Years
- • Diagnosed with ulcerative colitis
Where?
- • Bristol - Bristol Royal Infirmary
- • Glasgow - Ninewells Hospital
- • Liverpool - Alder Hey Children's Hospital
- • London - Chelsea and Westminster Hospital
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The aim of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of filgotinib as a treatment for UC in children and adolescents aged from 8 to less than 18 years. Approximately 80 subjects from 8 to \<18 years of age with moderately to severely active UC, including a minimum of 8 subjects from 8 to \<12 years of age, will be enrolled in this study. During the study, eligible subjects will take the investigational product (IP) on-site at Week 4, Week 10, and Week 22 (in the morning; with or without food). On all other days, subjects will take IP at home (in the morning; with or without food). Subjects who do not achieve mMCS remission and/or MCS response at Week 10 will continue with induction treatment until Week 22. Subjects who do not achieve PUCAI remission at Week 22 will be permanently discontinued from the study. Subjects will all receive a filgotinib dose targeting the same systemic exposure as that observed in adults with UC treated with 200 mg q.d.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 8 Years - 18 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ a minimum body weight (BW) of 15 kg
What the study is looking for
- ✓Subject must have a minimum body weight (BW) of 15 kg.
- ✓Subject:
- ✓has documented diagnosis of UC with a minimum duration of 3 months,
- ✓has mMCS of 5 to 9, and an MCS endoscopic score \>=2, rectal bleeding \>=1, and stool frequency \>=1,
Who cannot take part
- ✗Subject has a diagnosis of inflammatory bowel disease -unclassified or indeterminate colitis, isolated proctitis, or...
- ✗Subject has an active infection.
- ✗Subject with a history of complicated herpes zoster infection (with multi-dermatomal, disseminated, ophthalmic, or...
- ✗Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex, herpes...
- ✗Subject has a history of colectomy or extensive small bowel resection.
See the full criteria
Where Is This Study? (6 UK sites)
Bristol Royal Infirmary
Bristol BS2 8HW, United Kingdom
Ninewells Hospital
Glasgow G51 4TF, United Kingdom
Alder Hey Children's Hospital
Liverpool, United Kingdom
Chelsea and Westminster Hospital
London SW10 9NH, United Kingdom
The Newcastle upon Tyne Hospital FT
Newcastle NE1 4LP, United Kingdom
Sheffield Children's Hospital
Sheffield S10 2TH, United Kingdom
How to Get in Touch
Vincenzo Teneggi, MD
Sponsor contactCONTACT
Alexandra Mangili, MD
Sponsor contactCONTACT
