Actively Recruiting
A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis
Led by Alfasigma S.p.A. · Updated on 2026-02-06
80
Participants Needed
51
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Body weight of at least 15 kg
- Diagnosed with ulcerative colitis for at least 3 months
- Modified Mayo Clinic Score (mMCS) between 5 and 9
- Mayo Clinic Score (MCS) endoscopic score 2 or higher
- Rectal bleeding score of at least 1
- Stool frequency score of at least 1
- History of inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy
- Includes subjects 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 areas or central nervous system
- Currently receiving 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 that could interfere with study participation
- Prior use of 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
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
CONTACT
A
Alexandra Mangili, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here