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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2028

Conditions
Ulcerative Colitis
Interventions
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).

Trial Locations (43)

1020

Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola, Brussels

3116

Sykehuset I Vestfold HF, Tønsberg

4000

Centre Hospitalier Regional De La Citadelle, Liège

5000

Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur, Namur

10000

Children's Hospital Zagreb, Zagreb

University Hospital Centre Zagreb, Zagreb

11527

Athens General Children's Hospital Panagioti And Aglaia Kyriakou, Athens

12462

University General Hospital Attikon, Athens

15121

Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo, Alessandria

20154

ASST Fatebenefratelli Sacco, Milan

21000

Centre Hospitalier Universitaire De Dijon, Dijon

31000

Klinicki Bolnicki Centar Osijek, Osijek

34137

Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo, Trieste

34295

CHU de Montpellier, Montpellier

35200

Centre Hospitalier Universitaire De Rennes, Rennes

37000

Centre Hospitalier Regional Universitaire De Tours, Tours

52074

Universitaetsklinikum Aachen AöR, Aachen

54642

Hippokration Hospital, Thessaloniki

55131

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Mainz

56429

General Hospital Of Thessaloniki Papageorgiou, Efkarpia

59020

Groupement Des Hopitaux De L'Institut Catholique De Lille, Lille

60123

Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi, Ancona

69500

Hospital Femme Mere Enfant, Bron

72076

Universitaetsklinikum Tuebingen AöR, Tübingen

80131

Azienda Ospedaliera Universitaria Federico II Di Napoli, Naples

300011

Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara, Timișoara

04103

Universitaetsklinikum Leipzig AöR, Leipzig

D12 PN40

Children's Health Ireland, Dublin

00161

Azienda Ospedaliero-Universitaria Policlinico Umberto I, Rome

00165

Ospedale Pediatrico Bambino Gesu, Rome

0372

Oslo University Hospital HF, Oslo

85-048

In Vivo Sp. z o.o., Bydgoszcz

80-803

Copernicus Podmiot Leczniczy Sp. z o.o., Gdansk

30-663

Uniwersytecki Szpital Dzieciecy W Krakowie, Krakow

93-338

Instytut Centrum Zdrowia Matki Polki, Lodz

35-302

Gabinet Lekarski Bartosz Korczowski, Rzeszów

04-730

Instytut Pomnik Centrum Zdrowia Dziecka, Warsaw

4710-243

CCAB Centro Clinico Academico Braga Associacao, Braga

3000-602

Unidade Local De Saude De Coimbra E.P.E., Coimbra

4904-858

Unidade Local De Saude Do Alto Minho E.P.E., Viana do Castelo

022102

Dr. Victor Gomoiu Clinical Children Hospital, Bucharest

08916

Hospital Germans Trias I Pujol, Badalona

Unknown

Hospital Universitario Reina Sofia, Córdoba

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Alfasigma S.p.A.

INDUSTRY