A Phase 3 interventional study of Filgotinib in Ulcerative Colitis, sponsored by Alfasigma S.p.A.. Recruiting at 46 sites in 13 countries. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Alfasigma S.p.A. · Phase 3, Interventional, and Treatment
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.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 80 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Alfasigma S.p.A. is the lead sponsor of 24 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Filgotinib
Drug: Filgotinib
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. at approximately the same time every morning (with or without food).
Efficacy of filgotinib in induction of remission and maintenance of effect in pediatric subjects with ulcerative colitis (UC)
Proportion of subjects achieving clinical remission based on modified Mayo Clinical Score (mMCS)
Time frame: Week 10
subjects with ulcerative colitis (UC)
Proportion of subjects achieving clinical remission based on mMCS
Time frame: Week 58
Safety and tolerability of filgotinib in pediatric subjects with UC
Incidence of treatment-emergent adverse events (TEAEs), adverse events of interest, and laboratory abnormalities through follow-up
Time frame: Week 62
Safety and tolerability of filgotinib in pediatric subjects with UC
Change from baseline in body mass index (BMI)
Time frame: Week 58
Safety and tolerability of filgotinib in pediatric subjects with U
Change from baseline in height velocity
Time frame: Week 58
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: GLPG0634