Condition: Ulcerative Colitis · Sponsor: Alfasigma S.p.A.
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.
This description comes directly from the study's public registry record.
Vincenzo Teneggi, MD · 00800 7878 1345 · vincenzo.teneggi@external.alfasigma.com
Alexandra Mangili, MD · +041 795865622 · alexandra.mangili@alfasigma.com
Always discuss trial participation with your own doctor first.
| Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola | Brussels, Brussels Capital, Belgium | Not Yet Recruiting |
| Centre Hospitalier Regional De La Citadelle | Liège, Liege, Belgium | Not Yet Recruiting |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur | Namur, Namur, Belgium | Recruiting |
| Klinicki Bolnicki Centar Osijek | Osijek, Croatia, Croatia | Recruiting |
| Children's Hospital Zagreb | Zagreb, Croatia, Croatia | Recruiting |
| University Hospital Centre Zagreb | Zagreb, Croatia, Croatia | Recruiting |
| Hospital Femme Mere Enfant | Bron, France, France | Recruiting |
| Centre Hospitalier Universitaire De Dijon | Dijon, France, France | Recruiting |
| Hopital Saint Vincent de Paul - GHICL Lille | Lille, France, France | Recruiting |
| CHU de Montpellier | Montpellier, France, France | Recruiting |
| Centre Hospitalier Universitaire De Rennes | Rennes, France, France | Recruiting |
| Centre Hospitalier Regional Universitaire De Tours | Tours, France, France | Recruiting |
+ 35 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06865417