UCRecruiting
A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis
Phase 3 · Testing Filgotinib · 47 sites · Alfasigma S.p.A.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Filgotinib (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
It is open-label: participants know what they are receiving.
Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.
Who can join
- Ages 8 to 18
- Any sex
Some of the main requirements, copied from the record:
- Subject must have a minimum body weight (BW) of 15 kg.
- Subject:
- has documented diagnosis of UC with a minimum duration of 3 months,
Plus 2 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 80 participants are expected to take part.
- Start date: 2025-09-29.
- Main results expected around 2028-06 (estimate from the record).
- 47 study sites listed (41 marked recruiting) in Belgium, Croatia, France, Germany and Greece and 8 more countries.
Main thing being measured
- Efficacy of filgotinib in induction of remission and maintenance of effect in pediatric subjects with ulcerative colitis (UC) (Week 10)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Alfasigma S.p.A. |
| Enrollment | 80 (estimated) |
| Start date | 2025-09-29 |
| Primary completion (est.) | 2028-06 |
| First posted | 2025-03-07 |
| Last updated | 2026-08-12 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT06865417 |
Interventions
- Filgotinib (Drug)
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).
Full eligibility criteria (from the record)
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.
Locations (47)
Show all 47 sites
| Site | City | Country | Site status |
|---|---|---|---|
| Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola | Brussels, Brussels Capital | Belgium | Not yet recruiting |
| Centre Hospitalier Regional De La Citadelle | Liège, Liege | Belgium | Not yet recruiting |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur | Namur, Namur | Belgium | Recruiting |
| Klinicki Bolnicki Centar Osijek | Osijek, Croatia | Croatia | Recruiting |
| Children's Hospital Zagreb | Zagreb, Croatia | Croatia | Recruiting |
| University Hospital Centre Zagreb | Zagreb, Croatia | Croatia | Recruiting |
| Hospital Femme Mere Enfant | Bron, France | France | Recruiting |
| Centre Hospitalier Universitaire De Dijon | Dijon, France | France | Recruiting |
| Hopital Saint Vincent de Paul - GHICL Lille | Lille, France | France | Recruiting |
| CHU de Montpellier | Montpellier, France | France | Recruiting |
| Centre Hospitalier Universitaire De Rennes | Rennes, France | France | Recruiting |
| Centre Hospitalier Regional Universitaire De Tours | Tours, France | France | Recruiting |
| Universitaetsklinikum Aachen AöR | Aachen, Germany | Germany | Recruiting |
| Universitaetsklinikum Leipzig AöR | Leipzig, Germany | Germany | Recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR | Mainz, Germany | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR | Tübingen, Germany | Germany | Recruiting |
| Athens General Children's Hospital Panagioti And Aglaia Kyriakou | Athens, Greece | Greece | Not yet recruiting |
| University General Hospital Attikon | Athens, Greece | Greece | Recruiting |
| General Hospital Of Thessaloniki Papageorgiou | Efkarpia, Greece | Greece | Recruiting |
| Hippokration Hospital | Thessaloniki, Greece | Greece | Recruiting |
| Children's Health Ireland | Dublin, Ireland | Ireland | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo | Alessandria, Italy | Italy | Recruiting |
| Azienda Ospedaliero Universitaria dell Marche I G M Lancisi G Salesi | Ancona, Italy | Italy | Recruiting |
| ASST Fatebenefratelli Sacco | Milan, Italy | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Federico II Di Napoli | Naples, Italy | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I | Rome, Italy | Italy | Recruiting |
| Ospedale Pediatrico Bambino Gesu | Rome, Italy | Italy | Recruiting |
| IRCCS Materno Infantile Burlo Garofolo | Trieste, Italy | Italy | Recruiting |
| Oslo University Hospital HF | Oslo, Norway | Norway | Recruiting |
| Sykehuset I Vestfold HF | Tønsberg, Norway | Norway | Recruiting |
| In Vivo Sp. z o.o. | Bydgoszcz, Poland | Poland | Recruiting |
| Instytut Centrum Zdrowia Matki Polki | Lodz, Poland | Poland | Recruiting |
| Gabinet Lekarski Bartosz Korczowski | Rzeszów, Poland | Poland | Recruiting |
| Instytut Pomnik Centrum Zdrowia Dziecka | Warsaw, Poland | Poland | Recruiting |
| CCAB Centro Clinico Academico Braga Associacao | Braga, Portugal | Portugal | Recruiting |
| Hospital Pediátrico de Coimbra | Coimbra, Portugal | Portugal | Recruiting |
| Unidade Local De Saude Do Alto Minho E.P.E. | Viana do Castelo, Portugal | Portugal | Recruiting |
| Dr. Victor Gomoiu Clinical Children Hospital | Bucharest, Romania | Romania | Recruiting |
| Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara | Timișoara, Romania | Romania | Recruiting |
| Hospital Germans Trias I Pujol | Badalona, Spain | Spain | Recruiting |
| Hospital Universitario Reina Sofia | Córdoba, Spain | Spain | Recruiting |
| Bristol Royal Infirmary | Bristol | United Kingdom | Recruiting |
| Ninewells Hospital | Glasgow | United Kingdom | Recruiting |
| Alder Hey Children's Hospital | Liverpool | United Kingdom | Recruiting |
| Chelsea and Westminster Hospital | London | United Kingdom | Not yet recruiting |
| The Newcastle upon Tyne Hospital FT | Newcastle | United Kingdom | Not yet recruiting |
| Sheffield Children's Hospital | Sheffield | United Kingdom | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.