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

NCT06865417 | Recruiting Phase 3 DMC

• 1 other identifier: GLPG0634-CL-331
• Study Type: interventional
• Target: 80
• Locations: 13 countries
• Sites: 51

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• Efficacy of filgotinib in induction of remission and maintenance of effect in pediatric subjects with ulcerative colitis (UC)

  Proportion of subjects achieving clinical remission based on modified Mayo Clinical Score (mMCS)

  Week 10

• subjects with ulcerative colitis (UC)

  Proportion of subjects achieving clinical remission based on mMCS

  Week 58

Secondary Outcomes (3)

• Safety and tolerability of filgotinib in pediatric subjects with UC

  Week 62

• Safety and tolerability of filgotinib in pediatric subjects with UC

  Week 58

• Safety and tolerability of filgotinib in pediatric subjects with U

  Week 58

Study Arms (1)

Filgotinib

EXPERIMENTAL

Filgotinib

Drug: Filgotinib

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).

Filgotinib

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alfasigma S.p.A.: lead

Study Sites (51)

Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola

Brussels, Brussels Capital, 1020, Belgium

NOT YET RECRUITING

Centre Hospitalier Regional De La Citadelle

Liège, Liege, 4000, Belgium

RECRUITING

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

Namur, Namur, 5000, Belgium

NOT YET RECRUITING

Klinicki Bolnicki Centar Osijek

Osijek, Croatia, 31000, Croatia

NOT YET RECRUITING

Children's Hospital Zagreb

Zagreb, Croatia, 10000, Croatia

RECRUITING

University Hospital Centre Zagreb

Zagreb, Croatia, 10000, Croatia

RECRUITING

Hospital Femme Mere Enfant

Bron, France, 69500, France

RECRUITING

Centre Hospitalier Universitaire De Dijon

Dijon, France, 21000, France

RECRUITING

Hopital Saint Vincent de Paul - GHICL Lille

Lille, France, 59020, France

RECRUITING

CHU de Montpellier

Montpellier, France, 34295, France

RECRUITING

Centre Hospitalier Universitaire De Rennes

Rennes, France, 35200, France

RECRUITING

Centre Hospitalier Regional Universitaire De Tours

Tours, France, 37000, France

RECRUITING

Universitaetsklinikum Aachen AöR

Aachen, Germany, 52074, Germany

RECRUITING

Universitaetsklinikum Leipzig AöR

Leipzig, Germany, 04103, Germany

RECRUITING

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

Mainz, Germany, 55131, Germany

RECRUITING

Universitaetsklinikum Tuebingen AöR

Tübingen, Germany, 72076, Germany

RECRUITING

Athens General Children's Hospital Panagioti And Aglaia Kyriakou

Athens, Greece, 11527, Greece

NOT YET RECRUITING

University General Hospital Attikon

Athens, Greece, 12462, Greece

RECRUITING

General Hospital Of Thessaloniki Papageorgiou

Efkarpia, Greece, 56429, Greece

RECRUITING

Hippokration Hospital

Thessaloniki, Greece, 54642, Greece

RECRUITING

Children's Health Ireland

Dublin, Ireland, D12 PN40, Ireland

NOT YET RECRUITING

Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo

Alessandria, Italy, 15121, Italy

RECRUITING

Azienda Ospedaliero Universitaria dell Marche I G M Lancisi G Salesi

Ancona, Italy, 60123, Italy

RECRUITING

ASST Fatebenefratelli Sacco

Milan, Italy, 20154, Italy

RECRUITING

Azienda Ospedaliera Universitaria Federico II Di Napoli

Naples, Italy, 80131, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Rome, Italy, 00161, Italy

RECRUITING

Ospedale Pediatrico Bambino Gesu

Rome, Italy, 00165, Italy

RECRUITING

IRCCS Materno Infantile Burlo Garofolo

Trieste, Italy, 34137, Italy

RECRUITING

Oslo University Hospital HF

Oslo, Norway, 0372, Norway

RECRUITING

Sykehuset I Vestfold HF

Tønsberg, Norway, 3116, Norway

RECRUITING

In Vivo Sp. z o.o.

Bydgoszcz, Poland, 85-048, Poland

RECRUITING

Copernicus Podmiot Leczniczy Sp. z o.o.

Gdansk, Poland, 80-803, Poland

NOT YET RECRUITING

Uniwersytecki Szpital Dzieciecy W Krakowie

Krakow, Poland, 30-663, Poland

NOT YET RECRUITING

Instytut Centrum Zdrowia Matki Polki

Lodz, Poland, 93-338, Poland

NOT YET RECRUITING

Gabinet Lekarski Bartosz Korczowski

Rzeszów, Poland, 35-302, Poland

RECRUITING

Instytut Pomnik Centrum Zdrowia Dziecka

Warsaw, Poland, 04-730, Poland

RECRUITING

CCAB Centro Clinico Academico Braga Associacao

Braga, Portugal, 4710-243, Portugal

RECRUITING

Hospital Pediátrico de Coimbra

Coimbra, Portugal, 3000-602, Portugal

RECRUITING

Unidade Local De Saude Do Alto Minho E.P.E.

Viana do Castelo, Portugal, 4904-858, Portugal

RECRUITING

Dr. Victor Gomoiu Clinical Children Hospital

Bucharest, Romania, 022102, Romania

RECRUITING

Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara

Timișoara, Romania, 300011, Romania

RECRUITING

Hospital Germans Trias I Pujol

Badalona, Spain, 08916, Spain

NOT YET RECRUITING

Hospital Universitario Reina Sofia

Córdoba, Spain, Spain

RECRUITING

Bristol Royal Infirmary

Bristol, BS2 8HW, United Kingdom

RECRUITING

Noah's Ark Children's Hospital

Cardiff, CF14 4XW, United Kingdom

NOT YET RECRUITING

Ninewells Hospital

Glasgow, G51 4TF, United Kingdom

NOT YET RECRUITING

Alder Hey Children's Hospital

Liverpool, United Kingdom

NOT YET RECRUITING

Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

NOT YET RECRUITING

The Newcastle upon Tyne Hospital FT

Newcastle, NE1 4LP, United Kingdom

NOT YET RECRUITING

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

NOT YET RECRUITING

Sheffield Children's Hospital

Sheffield, S10 2TH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

GLPG0634

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Vincenzo Teneggi, MD

CONTACT

00800 7878 1345; vincenzo.teneggi@external.alfasigma.com

Alexandra Mangili, MD

CONTACT

+041 795865622; alexandra.mangili@alfasigma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 7, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

NO (2); PT (3); CR (3); FR (6); GB (8); GR (4); IT (7); PL (6); RO (2); ES (2); BE (3); DE (4); IE (1)