Actively Recruiting
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
Led by Alfasigma S.p.A. · Updated on 2026-02-06
80
Participants Needed
51
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating filgotinib in children and adolescents aged 8 to less than 18 years with moderately to severely active ulcerative colitis (UC). This study aims to assess the medicine's efficacy, safety, tolerability, and how the body processes it. About 80 participants will be enrolled, including at least 8 children aged 8 to under 12 years. The study focuses on those who have had insufficient response or intolerance to other treatments like corticosteroids or biologics. Participants will take filgotinib tablets once daily in the morning, with or without food. Doses are designed to achieve similar blood levels as seen in adults treated with 200 mg daily. On-site dosing will occur at Weeks 4, 10, and 22, while other doses are taken at home. Those not showing remission or response by Week 10 will continue induction treatment until Week 22. If remission is not reached by Week 22, participants will stop the study treatment. During the study, researchers will monitor participants' health, collecting data on remission rates and response at Week 10 and beyond. Safety and tolerability will be assessed through Week 58 and Week 62. Participants will have regular visits to take medicines, report symptoms, and undergo examinations. The total participation time can last over a year as the study tracks long-term effects and treatment outcomes.
CONDITIONS
Brief Title
A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must weigh at least 15 kg
- Aged 8 to less than 18 years
- Have a documented diagnosis of ulcerative colitis lasting at least 3 months
- Have a modified Mayo Clinic Score (mMCS) between 5 to 9
- Have an endoscopic Mayo Clinic Score (MCS) of 2 or higher
- Have rectal bleeding score of 1 or higher
- Have stool frequency score of 1 or higher
- Have had inadequate response, loss of response, intolerance, or contraindications to corticosteroids, immunosuppressants, or biologic therapy
- Includes those dependent on corticosteroids who worsen when tapering off
You will not qualify if you...
- Diagnosis of inflammatory bowel disease unclassified, indeterminate colitis, isolated proctitis, or toxic megacolon
- Active infection at the time of screening
- History of complicated herpes zoster infection involving multiple dermatomes, dissemination, eyes, or central nervous system
- Currently on therapy for chronic infections like pneumocystis, cytomegalovirus, herpes simplex, herpes zoster, or atypical mycobacteria
- History of colectomy or extensive small bowel resection
- Psychological or cognitive difficulties interfering with participation
- Previous exposure to Janus kinase inhibitors or similar medications (e.g., tofacitinib, baricitinib, upadacitinib)
- Female participants who are pregnant, breastfeeding, or intending to become pregnant or breastfeed during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 58 weeks
Participants receive daily oral Filgotinib to treat moderately to severely active ulcerative colitis.
Regular visits throughout treatment period
Duration - Up to 4 weeks after treatment
Participants are monitored for safety and tolerability of Filgotinib after treatment ends.
1 to 2 visits (in-person)
Trial Site Locations
Total: 51 locations
1
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Brussels, Brussels Capital, Belgium, 1020
Not Yet Recruiting
2
Centre Hospitalier Regional De La Citadelle
Liège, Liege, Belgium, 4000
Actively Recruiting
3
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Namur, Namur, Belgium, 5000
Not Yet Recruiting
4
Klinicki Bolnicki Centar Osijek
Osijek, Croatia, Croatia, 31000
Not Yet Recruiting
5
Children's Hospital Zagreb
Zagreb, Croatia, Croatia, 10000
Actively Recruiting
6
University Hospital Centre Zagreb
Zagreb, Croatia, Croatia, 10000
Actively Recruiting
7
Hospital Femme Mere Enfant
Bron, France, France, 69500
Actively Recruiting
8
Centre Hospitalier Universitaire De Dijon
Dijon, France, France, 21000
Actively Recruiting
9
Hopital Saint Vincent de Paul - GHICL Lille
Lille, France, France, 59020
Actively Recruiting
10
CHU de Montpellier
Montpellier, France, France, 34295
Actively Recruiting
11
Centre Hospitalier Universitaire De Rennes
Rennes, France, France, 35200
Actively Recruiting
12
Centre Hospitalier Regional Universitaire De Tours
Tours, France, France, 37000
Actively Recruiting
13
Universitaetsklinikum Aachen AöR
Aachen, Germany, Germany, 52074
Actively Recruiting
14
Universitaetsklinikum Leipzig AöR
Leipzig, Germany, Germany, 04103
Actively Recruiting
15
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Mainz, Germany, Germany, 55131
Actively Recruiting
16
Universitaetsklinikum Tuebingen AöR
Tübingen, Germany, Germany, 72076
Actively Recruiting
17
Athens General Children's Hospital Panagioti And Aglaia Kyriakou
Athens, Greece, Greece, 11527
Not Yet Recruiting
18
University General Hospital Attikon
Athens, Greece, Greece, 12462
Actively Recruiting
19
General Hospital Of Thessaloniki Papageorgiou
Efkarpia, Greece, Greece, 56429
Actively Recruiting
20
Hippokration Hospital
Thessaloniki, Greece, Greece, 54642
Actively Recruiting
21
Children's Health Ireland
Dublin, Ireland, Ireland, D12 PN40
Not Yet Recruiting
22
Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo
Alessandria, Italy, Italy, 15121
Actively Recruiting
23
Azienda Ospedaliero Universitaria dell Marche I G M Lancisi G Salesi
Ancona, Italy, Italy, 60123
Actively Recruiting
24
ASST Fatebenefratelli Sacco
Milan, Italy, Italy, 20154
Actively Recruiting
25
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy, Italy, 80131
Actively Recruiting
26
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Rome, Italy, Italy, 00161
Actively Recruiting
27
Ospedale Pediatrico Bambino Gesu
Rome, Italy, Italy, 00165
Actively Recruiting
28
IRCCS Materno Infantile Burlo Garofolo
Trieste, Italy, Italy, 34137
Actively Recruiting
29
Oslo University Hospital HF
Oslo, Norway, Norway, 0372
Actively Recruiting
30
Sykehuset I Vestfold HF
Tønsberg, Norway, Norway, 3116
Actively Recruiting
31
In Vivo Sp. z o.o.
Bydgoszcz, Poland, Poland, 85-048
Actively Recruiting
32
Copernicus Podmiot Leczniczy Sp. z o.o.
Gdansk, Poland, Poland, 80-803
Not Yet Recruiting
33
Uniwersytecki Szpital Dzieciecy W Krakowie
Krakow, Poland, Poland, 30-663
Not Yet Recruiting
34
Instytut Centrum Zdrowia Matki Polki
Lodz, Poland, Poland, 93-338
Not Yet Recruiting
35
Gabinet Lekarski Bartosz Korczowski
Rzeszów, Poland, Poland, 35-302
Actively Recruiting
36
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Poland, Poland, 04-730
Actively Recruiting
37
CCAB Centro Clinico Academico Braga Associacao
Braga, Portugal, Portugal, 4710-243
Actively Recruiting
38
Hospital Pediátrico de Coimbra
Coimbra, Portugal, Portugal, 3000-602
Actively Recruiting
39
Unidade Local De Saude Do Alto Minho E.P.E.
Viana do Castelo, Portugal, Portugal, 4904-858
Actively Recruiting
40
Dr. Victor Gomoiu Clinical Children Hospital
Bucharest, Romania, Romania, 022102
Actively Recruiting
41
Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara
Timișoara, Romania, Romania, 300011
Actively Recruiting
42
Hospital Germans Trias I Pujol
Badalona, Spain, Spain, 08916
Not Yet Recruiting
43
Hospital Universitario Reina Sofia
Córdoba, Spain, Spain
Actively Recruiting
44
Bristol Royal Infirmary
Bristol, United Kingdom, BS2 8HW
Actively Recruiting
45
Noah's Ark Children's Hospital
Cardiff, United Kingdom, CF14 4XW
Not Yet Recruiting
46
Ninewells Hospital
Glasgow, United Kingdom, G51 4TF
Not Yet Recruiting
47
Alder Hey Children's Hospital
Liverpool, United Kingdom
Not Yet Recruiting
48
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9NH
Not Yet Recruiting
49
The Newcastle upon Tyne Hospital FT
Newcastle, United Kingdom, NE1 4LP
Not Yet Recruiting
50
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Not Yet Recruiting
51
Sheffield Children's Hospital
Sheffield, United Kingdom, S10 2TH
Actively Recruiting
Research Team
V
Vincenzo Teneggi, MD
A
Alexandra Mangili, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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