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

NCT06865417 · tracked via the Priya Life Science Spain tracker

Sponsor

Alfasigma S.p.A

Phase

Phase 3

Started

2025-09-29

Last updated

2026-08-12

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

Filgotinib →

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).

Study summary

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.

Eligibility

Sex

ALL

Min age

8 Years

Max age

18 Years

Healthy volunteers

Inclusion Criteria: * Subject must have a minimum body weight (BW) of 15 kg. * Subject: * has documented diagnosis of UC with a minimum duration of 3 months, * has mMCS of 5 to 9, and an MCS endoscopic score \>=2, rectal bleeding \>=1, and stool frequency \>=1, * has had an inadequate response, loss of response, intolerance, or has medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy. This includes subjects who depend on corticosteroids to control their symptoms and who experience worsening of their disease when attempting to wean off corticosteroids. Exclusion Criteria: * Subject has a diagnosis of inflammatory bowel disease -unclassified or indeterminate colitis, isolated proctitis, or toxic megacolon. * Subject has an active infection. * Subject with a history of complicated herpes zoster infection (with multi-dermatomal, disseminated, ophthalmic, or central nervous system involvement). * Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex, herpes zoster, or atypical mycobacteria). * Subject has a history of colectomy or extensive small bowel resection. * Subject with psychological or cognitive difficulties that might interfere with study participation. * Subject has any previous exposure to a Janus kinase inhibitor or medication with a similar mode of action (e.g. tofacitinib, baricitinib, upadacitinib). * Female subject is pregnant or breast feeding or intending to become pregnant or breastfeed during the study.

Primary outcome measure(s)

Efficacy of filgotinib in induction of remission and maintenance of effect in pediatric subjects with ulcerative colitis (UC) — Week 10
Proportion of subjects achieving clinical remission based on modified Mayo Clinical Score (mMCS)
subjects with ulcerative colitis (UC) — Week 58
Proportion of subjects achieving clinical remission based on mMCS

Trial sites (47)

Facility	City	Region	Status
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola	Brussels	Brussels Capital	Not Yet Recruiting
Centre Hospitalier Regional De La Citadelle	Liège	Liege	Not Yet Recruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Namur	Recruiting
Klinicki Bolnicki Centar Osijek	Osijek	Croatia	Recruiting
Children's Hospital Zagreb	Zagreb	Croatia	Recruiting
University Hospital Centre Zagreb	Zagreb	Croatia	Recruiting
Hospital Femme Mere Enfant	Bron	France	Recruiting
Centre Hospitalier Universitaire De Dijon	Dijon	France	Recruiting
Hopital Saint Vincent de Paul - GHICL Lille	Lille	France	Recruiting
CHU de Montpellier	Montpellier	France	Recruiting
Centre Hospitalier Universitaire De Rennes	Rennes	France	Recruiting
Centre Hospitalier Regional Universitaire De Tours	Tours	France	Recruiting
Universitaetsklinikum Aachen AöR	Aachen	Germany	Recruiting
Universitaetsklinikum Leipzig AöR	Leipzig	Germany	Recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR	Mainz	Germany	Recruiting
Universitaetsklinikum Tuebingen AöR	Tübingen	Germany	Recruiting
Athens General Children's Hospital Panagioti And Aglaia Kyriakou	Athens	Greece	Not Yet Recruiting
University General Hospital Attikon	Athens	Greece	Recruiting
General Hospital Of Thessaloniki Papageorgiou	Efkarpia	Greece	Recruiting
Hippokration Hospital	Thessaloniki	Greece	Recruiting
Children's Health Ireland	Dublin	Ireland	Not Yet Recruiting
Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo	Alessandria	Italy	Recruiting
Azienda Ospedaliero Universitaria dell Marche I G M Lancisi G Salesi	Ancona	Italy	Recruiting
ASST Fatebenefratelli Sacco	Milan	Italy	Recruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy	Recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I	Rome	Italy	Recruiting
Ospedale Pediatrico Bambino Gesu	Rome	Italy	Recruiting
IRCCS Materno Infantile Burlo Garofolo	Trieste	Italy	Recruiting
Oslo University Hospital HF	Oslo	Norway	Recruiting
Sykehuset I Vestfold HF	Tønsberg	Norway	Recruiting
In Vivo Sp. z o.o.	Bydgoszcz	Poland	Recruiting
Instytut Centrum Zdrowia Matki Polki	Lodz	Poland	Recruiting
Gabinet Lekarski Bartosz Korczowski	Rzeszów	Poland	Recruiting
Instytut Pomnik Centrum Zdrowia Dziecka	Warsaw	Poland	Recruiting
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal	Recruiting
Hospital Pediátrico de Coimbra	Coimbra	Portugal	Recruiting
Unidade Local De Saude Do Alto Minho E.P.E.	Viana do Castelo	Portugal	Recruiting
Dr. Victor Gomoiu Clinical Children Hospital	Bucharest	Romania	Recruiting
Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara	Timișoara	Romania	Recruiting
Hospital Germans Trias I Pujol	Badalona	Spain	Recruiting

+ 7 more sites — see the full list on the official registry below.

More Alfasigma S.p.A. trials in Spain

Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis Active, not recruiting

Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC) Active, not recruiting

A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis Active, not recruiting

Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib for the Treatment of Polyarticular-course Juvenile Idiopathic Arthritis in Children and Adolescents Recruiting

Other trials for the same condition

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis Recruiting

ABTECT - Maintenance Active, not recruiting

Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC) Active, not recruiting

A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participants With Active Ulcerative Colitis Active, not recruiting

An Observational Study to Assess Change in Disease Activity and Adverse Events of Upadacitinib in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Real-World Practice Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06865417 on ClinicalTrials.gov ↗ ← All trials in Spain