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A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis

Study acronym: Galapeduca
StatusRecruiting
PhasePhase 3
Started2025-09-29
View on ClinicalTrials.gov ↗

Amendment history

2026-08-11
Study Status, Contacts/Locations v8
Study sitesdetails revised at 1 of 47 sites
2026-06-10
Study Status, Contacts/Locations v7
Trial sites reduced: 51 → 47 locations
2026-02-04
Study Status, Contacts/Locations v6
Study sitesdetails revised at 7 of 51 sites
2025-12-03
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations, IPDSharing v5
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-06→2028-06
Start dateestimated 2025-09→confirmed 2025-09-29
Study sites43→51
2025-08-11
Study Status v4
Start date2025-07→2025-09
Show 3 earlier versions
2025-07-01
Study Status, Oversight, Contacts/Locations, IPDSharing v3
Start date2025-05→2025-07
Study sitesdetails revised at 43 of 43 sites
2025-03-17
Study Status, Arms and Interventions v2
Re-verified, no change to tracked fields
2025-03-13
Study Identification, Study Status, Arms and Interventions, Contacts/Locations v1
Study sites3→43
Study arms0→1
2025-03-04
Original filing
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.
Trial Details
NCT Number NCT06865417
Lead Sponsor Alfasigma S.p.A.
Conditions Ulcerative Colitis
Enrollment 80 participants
Start Date 2025-09-29
Primary Completion 2028-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-12