Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC) (GALOCEAN)

December 18, 2025 updated by: Alfasigma S.p.A.

A Prospective, Non-interventional, Multi-country Cohort Study of the Effectiveness and Safety of Filgotinib in Adult Patients With Moderately to Severely Active Ulcerative Colitis

To describe the effectiveness, treatment patterns, quality of life, and safety of participants with moderately or severely active UC treated with filgotinib in a real-world setting.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

509

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • LKH - Universitätsklinikum Graz
      • Klagenfurt, Austria, 9020
        • Klinikum Klagenfurt am Wörthersee
      • Sankt Veit an der Glan, Austria, 9300
        • KH der Barmherzigen Brüder St.Veit an der Glan
      • Vienna, Austria, 1090
        • AKH - Medizinische Universität Wien
  • Belgium
      • Bonheiden, Belgium, 2820
        • Imeldaziekenhuis
      • Brussels, Belgium, 1070
        • Cliniques Universitaires de Bruxelles Hopital Erasme
      • Brussels, Belgium, 1000
        • CHU Saint-Pierre
      • Edegem, Belgium, 2650
        • UZA
      • Ghent, Belgium, 9000
        • AZ Sint-Lucas
      • Ghent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Ghent, Belgium, 9000
        • AZ Maria Middelares
      • Heusden-Zolder, Belgium, 3550
        • Sint-Franciscus ziekenhuis
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium, 4000
        • CHU de Liège
      • Liège, Belgium, 4000
        • Clinique CHC MontLégia
      • Ostend, Belgium, 8400
        • AZ Damiaan
  • France
      • Amiens, France, 80000
        • CHU Amiens - Hopital Sud
      • Besançon, France, 25000
        • Hopital Jean Minjoz
      • Clichy, France, 92200
        • Clinique Abroise Paré
      • Grenoble, France, 38043
        • CHU de Grenoble - Hôpital Nord
      • Lille, France, 59000
        • CHU Lille - Hôpital Claude Huriez
      • Montpellier, France, 34090
        • CHU Montpellier- Hôpital Saint Eloi
      • Nancy, France, 54000
        • CHRU de Nancy
      • Nantes, France, 44093
        • CHU Nantes - Hôtel Dieu
      • Paris, France, 75010
        • Hôpital Saint-Louis
      • Pessac, France, 33604
        • CHU Bordeaux - Hôpital Haut-Lévêque
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon sud
      • Saint-Etienne, France, 42055
        • CHU Saint Etienne - Hôpital Nord
      • Toulouse, France, 31059
        • Hopital Rangueil
  • Germany
      • Amberg, Germany, 92224
        • Klinikum St. Marien Amberg
      • Dachau, Germany, 85221
        • Medizinisches Versorgungszentrum Dachau
      • Hamburg, Germany, 22041
        • Fachinternistische Schwerpunktpraxis
      • Heidelberg, Germany, 69115
        • Praxis fur Gastroenterologie
      • Kiel, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig AöR
      • Münster, Germany, 48159
        • Gastro Campus Research GbR
      • Remscheid, Germany, 42859
        • Magen-Darm-Zentrum Remscheid
      • Tübingen, Germany, 72076
        • Universitatsklinikum Tubingen
    • Bavaria
      • Grünwald, Bavaria, Germany, 82031
        • Synesis GmbH
  • Ireland
      • Cork, Ireland, T12 DFK4
        • Cork University Hospital
      • Dublin, Ireland, D04 T6F4
        • St Vincent's University Hospital
      • Dublin, Ireland, D09 A0HK
        • Beaumont Hospital
  • Italy
      • Milan, Italy, 20122
        • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
      • Milan, Italy, 20157
        • ASST Fatebenefratelli Sacco
      • Negrar, Italy, 37024
        • IRCCS Ospedale Sacro Cuore Don Calabria
      • Palermo, Italy, 90146
        • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
      • Rozzano, Italy, 20089
        • Irccs Istituto Clinico Humanitas
      • Torino, Italy, 10128
        • Ospedale Mauriziano Umberto I
    • Italia
      • Bari, Italia, Italy, 70013
        • Azienda Ospedaliera Saverio De Bellis - Castellana Grotte
      • Milan, Italia, Italy, 20132
        • IRCCS Ospedale San Raffaele ,Via Olgettina 60
      • Pisa, Italia, Italy, 56124
        • Azienda Ospedaliero Universitaria Pisana - Cisanello
  • Netherlands
      • Amsterdam, Netherlands, 1091 AC
        • Onze Lieve Vrouwe Gasthuis
      • Amsterdam, Netherlands, 1105 AZ
        • Amsterdam UMC (AMC)
      • Geleen, Netherlands, 6162 BG
        • Zuyderland Medisch Centrum - Sittard-Geleen
      • Nijmegen, Netherlands, 6525 GA
        • Radboud UMC
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus MC
      • Rotterdam, Netherlands, 3045 PM
        • Franciscus Gasthuis
      • Tilburg, Netherlands, 5022 GC
        • ETZ Elisabeth
      • Utrecht, Netherlands, 3584 CX
        • UMC Utrecht
  • Norway
      • Bodø, Norway, 8092
        • Nordlandsykehuset
      • Lørenskog, Norway, 1478
        • Akershus Universitetssykehus
      • Oslo, Norway, 0424
        • Oslo University Hospital
      • Oslo, Norway, 1346
        • Bærum Hospital , Gjettum
      • Tromsø, Norway, 9019
        • Universitetssykehuset Nord-Norge
      • Trondheim, Norway, 7030
        • St. Olav's University Hospital
  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
    • Spain
      • Badalona, Spain, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain, Spain, 08036
        • Hospital Clinic de Barcelona, C/ Villarroel, 170
      • Las Palmas de Gran Canaria, Spain, Spain, 35012
        • Hospital Universitario de Gran Canaria Dr. Negrín
      • Palma de Mallorca, Spain, Spain, 07120
        • Hospital Universitari Son Espases
      • Santiago de Compostela, Spain, Spain, 15706
        • Hospital Universitario de Santiago de Compostela
  • United Kingdom
      • Belfast, United Kingdom, BT161RH
        • The Ulster Hospital
      • Bury, United Kingdom, BL97TD
        • Bury Care Organisation
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon University Healthcare NHS Foundation Trust
      • Glasgow, United Kingdom, G514TF
        • Queen Elizabeth University Hospital
      • Glasgow, United Kingdom, G40SF
        • Glasgow Royal Infirmary
      • London, United Kingdom, SW170QT
        • St George's Hospital
      • London, United Kingdom, NW10 7NS
        • St Mark's Hospital, Central Middlesex, Acton Lane
      • Norwich, United Kingdom, NR47UY
        • Norfolk and Norwich University Hospital
      • Oxford, United Kingdom, OX39DU
        • John Radcliffe Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of participants aged 18 years or older with moderately or severely active UC as judged by the physician and starting filgotinib treatment. Participants are enrolled across around 10 countries in Europe, including the United Kingdom.

Description

Inclusion Criteria:

1. Filgotinib-naïve participants with moderately or severely active UC as judged by the physician and starting filgotinib treatment according to local treatment guidelines, routine practices and product information.

Exclusion Criteria:

  1. Participation in any interventional or non-interventional study without prior approval from the medical leader. This does not preclude inclusion of participants enrolled to national registries.
  2. Participant is diagnosed with Crohn's disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arm A: Filgotinib
Participants diagnosed with moderately or severely active UC taking filgotinib according to local treatment guidelines or routine clinical practice and product information.
Drug: Filgotinib
Jyseleca

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Persistence Rate at week 52.
Time Frame: Week 52
The persistence rate is defined as the percentage of participants who have continued filgotinib treatment since initiation.
Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in HRQoL as measured by the Urgency Numeric Rating Scale (NRS)
Time Frame: Baseline, Weeks 10, 24, 52
Baseline, Weeks 10, 24, 52
Treatment Persistence Rate at weeks 10, 24, 76 and 104
Time Frame: Weeks 10, 24, 76 and 104
Weeks 10, 24, 76 and 104
Clinical Response Rate
Time Frame: Weeks 10, 24, 52, 76 and 104
Weeks 10, 24, 52, 76 and 104
Clinical Remission Rate
Time Frame: Weeks 10, 24, 52, 76 and 104
Weeks 10, 24, 52, 76 and 104
Change from Baseline in Health-Related Quality of Life (HRQoL) as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time Frame: Baseline, Weeks 10, 24, 52, 76 and 104
Baseline, Weeks 10, 24, 52, 76 and 104
Change from Baseline in HRQoL as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F)
Time Frame: Baseline, Weeks 10, 24, 52, 76 and 104
Baseline, Weeks 10, 24, 52, 76 and 104
Number of Participants with Adverse Events (AEs)
Time Frame: Up to 104 Weeks
Up to 104 Weeks
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: Up To 104 Weeks
Up To 104 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alfasigma S.p.A.

Investigators

  • Study Director: Alfasigma Study Director, Alfasigma S.p.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

April 5, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLPG0634-CL-425
  • 105477 (Other Identifier: HMA-EMA Catalogues)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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