Ulcerative ColitisGALOCEANNCT05817942
Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC)
An observational study of Ulcerative Colitis, run by Alfasigma S.p.A. at 81 sites in 10 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Filgotinib
- How many people
- 509 participants
- Where
- 81 sitesin 10 countries
- Study dates
- 12 Jun 2023to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
- Participant is diagnosed with Crohn's disease.
Trial locations and contacts
81 sites in 10 countries.
81 sites in 10 countries
France13 sites
CHU Amiens - Hopital Sud
Amiens, 80000
Hôpital Jean Minjoz
Besançon, 25000
Clinique Abroise Paré
Clichy, 92200
CHU de Grenoble - Hôpital Nord
Grenoble, 38043
CHU Lille - Hôpital Claude Huriez
Lille, 59000
CHU Montpellier- Hôpital Saint Eloi
Montpellier, 34090
CHRU de Nancy
Nancy, 54000
CHU Nantes - Hôtel Dieu
Nantes, 44093
Hôpital Saint-Louis
Paris, 75010
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, 33604
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
CHU Saint Etienne - Hôpital Nord
Saint-Etienne, 42055
Hôpital Rangueil
Toulouse, 31059
Belgium12 sites
Imeldaziekenhuis
Bonheiden, 2820
CHU Saint-Pierre
Brussels, 1000
Cliniques Universitaires de Bruxelles Hopital Erasme
Brussels, 1070
UZA
Edegem, 2650
AZ Maria Middelares
Ghent, 9000
AZ Sint-Lucas
Ghent, 9000
Universitair Ziekenhuis Gent
Ghent, 9000
Sint-Franciscus ziekenhuis
Heusden-Zolder, 3550
UZ Leuven
Leuven, 3000
CHU de Liège
Liège, 4000
Clinique CHC MontLégia
Liège, 4000
AZ Damiaan
Ostend, 8400
Germany10 sites
Klinikum St. Marien Amberg
Amberg, 92224
Medizinisches Versorgungszentrum Dachau
Dachau, 85221
Synesis GmbH
Grünwald, Bavaria, 82031
Fachinternistische Schwerpunktpraxis
Hamburg, 22041
Praxis fur Gastroenterologie
Heidelberg, 69115
Universitaetsklinikum Schleswig-Holstein
Kiel, 24105
Universitätsklinikum Leipzig AöR
Leipzig, 04103
Gastro Campus Research GbR
Münster, 48159
Magen-Darm-Zentrum Remscheid
Remscheid, 42859
Universitätsklinikum Tübingen
Tübingen, 72076
United Kingdom10 sites
The Ulster Hospital
Belfast, BT161RH
Bury Care Organisation
Bury, BL97TD
Royal Devon University Healthcare NHS Foundation trust
Exeter, EX2 5DW
Glasgow Royal Infirmary
Glasgow, G40SF
Queen Elizabeth University Hospital
Glasgow, G514TF
St Mark's Hospital, Central Middlesex, Acton Lane
London, NW10 7NS
St George's Hospital
London, SW170QT
Norfolk and Norwich University Hospital
Norwich, NR47UY
John Radcliffe Hospital
Oxford, OX39DU
Southampton General Hospital
Southampton, SO16 6YD
Italy9 sites
Azienda Ospedaliera Saverio De Bellis - Castellana Grotte
Bari, Italia, 70013
IRCCS Ospedale San Raffaele ,Via Olgettina 60
Milan, Italia, 20132
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, 20122
ASST Fatebenefratelli Sacco
Milan, 20157
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, 37024
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo, 90146
Azienda Ospedaliero Universitaria Pisana - Cisanello
Pisa, Italia, 56124
IRCCS Istituto Clinico Humanitas
Rozzano, 20089
Ospedale Mauriziano Umberto I
Torino, 10128
Netherlands8 sites
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091 AC
Amsterdam UMC (AMC)
Amsterdam, 1105 AZ
Zuyderland Medisch Centrum - Sittard-Geleen
Geleen, 6162 BG
Radboud UMC
Nijmegen, 6525 GA
Erasmus MC
Rotterdam, 3015 GD
Franciscus Gasthuis
Rotterdam, 3045 PM
ETZ Elisabeth
Tilburg, 5022 GC
UMC Utrecht
Utrecht, 3584 CX
Norway6 sites
Nordlandsykehuset
Bodø, 8092
Akershus Universitetssykehus
Lørenskog, 1478
Oslo University Hospital
Oslo, 0424
Bærum Hospital , Gjettum
Oslo, 1346
Universitetssykehuset Nord-Norge
Tromsø, 9019
St. Olav's University Hospital
Trondheim, 7030
Spain6 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Spain, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08025
Hospital Clinic de Barcelona, C/ Villarroel, 170
Barcelona, Spain, 08036
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, Spain, 35012
Hospital Universitari Son Espases
Palma de Mallorca, Spain, 07120
Hospital Universitario de Santiago de Compostela
Santiago de Compostela, Spain, 15706
Austria4 sites
LKH - Universitätsklinikum Graz
Graz, 8036
Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020
KH der Barmherzigen Brüder St.Veit an der Glan
Sankt Veit an der Glan, 9300
AKH - Medizinische Universität Wien
Vienna, 1090
Ireland3 sites
Cork University Hospital
Cork, T12 DFK4
St Vincent's University Hospital
Dublin, D04 T6F4
Beaumont Hospital
Dublin, D09 A0HK
About this study
Official title: 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.
- Conditions
- Ulcerative Colitis
- Being tested
- Filgotinib
- Keywords
- filgotinib, safety, efficacy
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgotinibDrug
Jyseleca
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Filgotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Persistence Rate at week 52.
The persistence rate is defined as the percentage of participants who have continued filgotinib treatment since initiation.
Measured: Week 52
Secondary outcomes (8)
Treatment Persistence Rate at weeks 10, 24, 76 and 104
Measured: Weeks 10, 24, 76 and 104
Clinical Response Rate
Measured: Weeks 10, 24, 52, 76 and 104
Clinical Remission Rate
Measured: 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)
Measured: Baseline, Weeks 10, 24, 52, 76 and 104
Change from Baseline in HRQoL as measured by the Urgency Numeric Rating Scale (NRS)
Measured: Baseline, Weeks 10, 24, 52
Change from Baseline in HRQoL as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F)
Measured: Baseline, Weeks 10, 24, 52, 76 and 104
Number of Participants with Adverse Events (AEs)
Measured: Up to 104 Weeks
Number of Participants with Serious Adverse Events (SAEs)
Measured: Up To 104 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start12 Jun 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alfasigma S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alfasigma Study Director, Study director, Alfasigma S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817942
- Sponsor's protocol ID
- GLPG0634-CL-425
- Other IDs
- 105477
- Acronym
- GALOCEAN
- Status last verified
- Dec 2025
- First submitted
- 5 Apr 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05817942
- Acronym / sponsor ID
- GALOCEAN / GLPG0634-CL-425
- Conditions
- Ulcerative Colitis
- Keywords
- filgotinib, safety, efficacy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Alfasigma S.p.A.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A: Filgotinib | – | Drug: FilgotinibParticipants diagnosed with moderately or severely active UC taking filgotinib according to local treatment guidelines or routine clinical practice and product information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
- Participant is diagnosed with Crohn's disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FilgotinibJyseleca | Drug | Arm A: Filgotinib |
Primary outcome
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.
8 secondary outcomes
Treatment Persistence Rate at weeks 10, 24, 76 and 104
Time frame: Weeks 10, 24, 76 and 104
Clinical Response Rate
Time frame: Weeks 10, 24, 52, 76 and 104
Clinical Remission Rate
Time frame: 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
Change from Baseline in HRQoL as measured by the Urgency Numeric Rating Scale (NRS)
Time frame: Baseline, Weeks 10, 24, 52
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
Number of Participants with Adverse Events (AEs)
Time frame: Up to 104 Weeks
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up To 104 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfasigma Study Director study director
Alfasigma S.p.A.
81 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Alfasigma S.p.A. at 81 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in France, Belgium, Germany, United Kingdom, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Persistence Rate at week 52. (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.