A study evaluating the effects of filgotinib in children and teenagers with ulcerative colitis
Key facts
- Where
- Alexandria, Ancona, Milan, Naples, Rome és Trieste, OlaszországSee the 7 sites
- Phase
- 3. fázis
Where in Olaszország
- Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare ArrigoAlexandria, OlaszországTaking people
- Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G SalesiAncona, OlaszországTaking people
- ASST Fatebenefratelli SaccoMilan, OlaszországTaking people
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, OlaszországTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, OlaszországTaking people
- Ospedale Pediatrico Bambino GesùRome, OlaszországTaking people
- Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo GarofoloTrieste, OlaszországTaking 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
- EU 2024-511458-32-00
- Record updated
- 2026. október 26.
- Original description
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.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
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.
Inclusion: 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.
Exclusion: 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.