Tests filgotinib for ulcerative colitis in children and teenagers
Tests filgotinib in children and teenagers with moderately to severely active ulcerative colitis.
Plain-language title generated from the registry record
Registry title: A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis
Key facts
- Where
- Alessandria, Ancona, Milan, Naples, Rome, and Trieste, ItalySee the 7 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 18 years old?
Source: NCT06865417, who can take part
Where in Italy
- Azienda Ospedaliero Universitaria "SS Antonio e Biagio e Cesare Arrigo"Alessandria, ItalyTaking people
- Azienda Ospedaliero Universitaria dell Marche I G M Lancisi G SalesiAncona, ItalyTaking people
- ASST Fatebenefratelli SaccoMilan, ItalyTaking people
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
- Ospedale Pediatrico Bambino GesùRome, ItalyTaking people
- IRCCS materno infantile Burlo GarofoloTrieste, ItalyTaking people
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?
Trial details
- Who runs it
- Alfasigma S.p.A.
- Trial code
- NCT06865417
- Record updated
- 20 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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,; 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.
Exclusion: Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex, herpes zoster, or atypical mycobacteria); Subject has any previous exposure to a Janus kinase inhibitor or medication with a similar mode of action (e.g. tofacitinib, baricitinib, upadacitinib); Subject has a diagnosis of inflammatory bowel disease -unclassified or indeterminate colitis, isolated proctitis, or toxic megacolon; 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 has a history of colectomy or extensive small bowel resection; 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.