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

Phase 3

Not yet recruiting

• Conditions: Ulcerative Colitis
• Interventions: Drug: Filgotinib

• Registration Number: NCT06865417
• Lead Sponsor: Alfasigma S.p.A.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-04
• Study First Posted: 2025-03-07
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Study Start: 2025-05
• Primary Completion: 2027-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Filgotinib	Filgotinib	Filgotinib

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of filgotinib in pediatric subjects with UC	Week 58	Change from baseline in body mass index (BMI)
Safety and tolerability of filgotinib in pediatric subjects with U	Week 58	Change from baseline in height velocity

Trial Locations

Locations (43)

Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola; 🇧🇪 Brussels, Belgium

Centre Hospitalier Regional De La Citadelle; 🇧🇪 Liege, Belgium

Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur; 🇧🇪 Namur, Belgium

Klinicki Bolnicki Centar Osijek; 🇭🇷 Osijek, Croatia

Children's Hospital Zagreb; 🇭🇷 Zagreb, Croatia

University Hospital Centre Zagreb; 🇭🇷 Zagreb, Croatia

Hospital Femme Mere Enfant; 🇫🇷 Bron, France

Centre Hospitalier Universitaire De Dijon; 🇫🇷 Dijon, France

Groupement Des Hopitaux De L'Institut Catholique De Lille; 🇫🇷 Lille Cedex, France

CHU de Montpellier; 🇫🇷 Montpellier Cedex 05, France

Centre Hospitalier Universitaire De Rennes; 🇫🇷 Rennes, France

Centre Hospitalier Regional Universitaire De Tours; 🇫🇷 Tours, France

Universitaetsklinikum Aachen AöR; 🇩🇪 Aachen, Germany

Universitaetsklinikum Leipzig AöR; 🇩🇪 Leipzig, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR; 🇩🇪 Mainz, Germany

Universitaetsklinikum Tuebingen AöR; 🇩🇪 Tuebingen, Germany

Athens General Children's Hospital Panagioti And Aglaia Kyriakou; 🇬🇷 Athens, Greece

University General Hospital Attikon; 🇬🇷 Athens, Greece

General Hospital Of Thessaloniki Papageorgiou; 🇬🇷 Efkarpia, Greece

Unidade Local De Saude De Coimbra E.P.E.; 🇵🇹 Coimbra, Portugal

Hippokration Hospital; 🇬🇷 Thessaloniki, Greece

Children's Health Ireland; 🇮🇪 Dublin, Ireland

Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo; 🇮🇹 Alessandria, Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi; 🇮🇹 Ancona, Italy

ASST Fatebenefratelli Sacco; 🇮🇹 Milan, Italy

Azienda Ospedaliera Universitaria Federico II Di Napoli; 🇮🇹 Naples, Italy

CCAB Centro Clinico Academico Braga Associacao; 🇵🇹 Braga, Portugal

Azienda Ospedaliero-Universitaria Policlinico Umberto I; 🇮🇹 Rome, Italy

Ospedale Pediatrico Bambino Gesu; 🇮🇹 Rome, Italy

Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo; 🇮🇹 Trieste, Italy

Oslo University Hospital HF; 🇳🇴 Oslo, Norway

Sykehuset I Vestfold HF; 🇳🇴 Tønsberg, Norway

In Vivo Sp. z o.o.; 🇵🇱 Bydgoszcz, Poland

Copernicus Podmiot Leczniczy Sp. z o.o.; 🇵🇱 Gdansk, Poland

Uniwersytecki Szpital Dzieciecy W Krakowie; 🇵🇱 Kraków, Poland

Instytut Centrum Zdrowia Matki Polki; 🇵🇱 Lodz, Poland

Gabinet Lekarski Bartosz Korczowski; 🇵🇱 Rzeszów, Poland

Instytut Pomnik Centrum Zdrowia Dziecka; 🇵🇱 Warsaw, Poland

Unidade Local De Saude Do Alto Minho E.P.E.; 🇵🇹 Viana Do Castelo, Portugal

Dr. Victor Gomoiu Clinical Children Hospital; 🇷🇴 Bucharest, Romania

Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara; 🇷🇴 Timisoara, Romania

Hospital Germans Trias I Pujol; 🇪🇸 Badalona, Spain

Hospital Universitario Reina Sofia; 🇪🇸 Cordoba, Spain