Taking people in IrelandPhase 3
Tests filgotinib in children and teens with ulcerative colitis
Tests filgotinib in young people aged 8 to 17 with ulcerative colitis, a bowel disease.
Key facts
- Who runs it
- Alfasigma S.p.A.
- Where
- Dublin, IrelandSee the siteAlso in 11 other countries, 40 sites
- Trial code
- Registry title
- A study evaluating the effects of filgotinib in children and teenagers with ulcerative colitis
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 68 people, planned
- Started
- 15 Jun 2025
- Expected to end
- 12 Mar 2030
- Type of study
- Interventional
- Record updated
- 12 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers aged 8 to under 18 with moderately to severely active ulcerative colitis, weighing at least 15 kg (33 lb), who did not respond well to earlier treatment.
- Age
- 8 to under 18 years old
- Sex
- Girls and boys can both join.
- Disease stage
- Ulcerative colitis for at least 3 months, moderately to severely active (mMCS 5 to 9, endoscopic score >=2, rectal bleeding >=1, stool frequency >=1).
- Earlier treatment
- Must have had an inadequate response, loss of response or intolerance to corticosteroids, immunosuppressants and/or biologic therapy, or have medical reasons not to take them. Must never have taken a JAK inhibitor (for example tofacitinib, baricitinib, upadacitinib).
Main reasons for not taking part
- Unclassified IBD, indeterminate colitis, isolated proctitis or toxic megacolon
- Past colectomy or large small bowel resection
- Any previous JAK inhibitor treatment
- Active infection, or a past complicated herpes zoster infection
- Pregnant, breastfeeding, or planning pregnancy or breastfeeding during the study
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Subject must have a minimum BW of 15 kg
- Subject: a. has documented diagnosis of UC with a minimum duration of 3 months, b. has mMCS of 5 to 9, and an MCS endoscopic score >=2, rectal bleeding >=1, and stool frequency >=1, c. has had an inadequate response, loss of response, intolerance, or has medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy. This includes subjects who depend on corticosteroids to control their symptoms and who experience worsening of their disease when attempting to wean off corticosteroids
- Female or male subjects from 8 to <18 years of age, on the date of signing the ICF. If a subject turns 18 years old during the Induction Phase or Maintenance Phase, he/she must sign an adult ICF to continue through the end of the Maintenance Phase (Week 58). Subjects must be <18 years of age to rollover into the LTE Phase. Subjects who become 18 years of age during the LTE Phase will be allowed to complete the study (up to an additional 78 weeks) or to switch to filgotinib if commercially available
- Subject and/or parent/legal guardian must be able and willing to comply with the clinical study protocol requirements and must sign and date the ICF and assent (if required per local regulation) as approved by the Independent Ethics Committee/ Institutional Review Board, prior to any screening evaluations
Who cannot take part
- Subject has any previous exposure to a Janus kinase (JAK) inhibitor or medication with a similar mode of action (e.g. tofacitinib, baricitinib, upadacitinib)
- Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex, herpes zoster, or atypical mycobacteria)
- Subject has a diagnosis of inflammatory bowel disease (IBD)-unclassified or indeterminate colitis, isolated proctitis, or toxic megacolon
- Subject has a history of colectomy or extensive small bowel resection
- Subject has an active infection
- Subject with a history of complicated herpes zoster infection (with multi-dermatomal, disseminated, ophthalmic, or central nervous system involvement)
- Subject with psychological or cognitive difficulties that might interfere with study participation
- Female subject is pregnant or breast feeding or intending to become pregnant or breastfeed during the study
Where in Ireland
Also in 11 other countries, 40 sites
- Children's Health IrelandDublin, IrelandTaking people
About the trial
What the trial wants to find out
Induction Phase and Maintenance Phase: to evaluate the efficacy of filgotinib in induction of remission and maintenance of effect in pediatric subjects with UC. Long-term: to determine the long-term safety and tolerability of filgotinib in pediatric subjects with UC.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- A multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of filgotinib, with single arm induction and maintenance, in pediatric subjects (8 to <18 years of age) with moderately to severely active ulcerative colitis
- Plain-language title
- Tests filgotinib in children and teens with ulcerative colitisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 12 November 2026