Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05817942 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: GALOCEAN
StatusActive, Not Recruiting
PhaseNot specified
Started2023-06-12
View on ClinicalTrials.gov ↗

Amendment history

2025-12-18
Study Status, Oversight, Study Design v23
Enrollment target520→509
2025-09-02
Study Status, Study Design v22
Enrollment target519→520
2025-08-19
Recruiting→Active, Not Recruiting Study Status, Oversight, Study Design, Contacts/Locations v21
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 600→confirmed 519
Study sites83→81
2025-06-20
Study Status, Contacts/Locations v20
Study sites81→83
2025-03-10
Study Status, Contacts/Locations v19
Study sites75→81
Show 18 earlier versions
2024-12-13
Study Status, Contacts/Locations v18
Study sites73→75
2024-09-06
Study Status, Contacts/Locations v17
Study sites70→73
2024-08-16
Study Identification, Study Status, Sponsor/Collaborators, Outcome Measures, Contacts/Locations v16
Primary completion date2025-12→2027-12
Completion date2025-12→2027-12
Lead sponsorLakefront Biotherapeutics NV→Alfasigma S.p.A.
Secondary endpoints8 entries, revised
Treatment Persistence Rate at weeks 10, 24, 76 and 24104
2024-06-11
Study Status, Contacts/Locations v15
Study sites67→70
2024-05-08
Study Status, Contacts/Locations v14
Study sites66→67
2024-04-09
Study Status, Contacts/Locations v13
Study sites63→66
2024-03-06
Study Identification, Study Status, Contacts/Locations v12
Study sites60→63
2024-02-07
Study Status, Contacts/Locations v11
Study sites54→60
2024-01-09
Study Status, Contacts/Locations v10
Study sites49→54
2023-12-08
Study Status, Contacts/Locations v9
Study sites43→49
2023-11-10
Study Status, Contacts/Locations v8
Study sites32→43
2023-10-13
Study Status, Contacts/Locations v7
Study sites16→32
2023-09-15
Study Status, Contacts/Locations v6
Study sitesdetails revised at 1 of 16 sites
2023-07-17
Study Status, Contacts/Locations v5
Study sites11→16
2023-06-27
Study Status, Contacts/Locations v4
Start dateestimated 2023-06→confirmed 2023-06-12
Study sites3→11
2023-06-02
Study Status, Contacts/Locations v3
Start date2023-05→2023-06
Study sites1→3
2023-05-04
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2023-04→2023-05
Study sitesdetails revised at 1 of 1 site
2023-04-18
Study Status, Conditions v1
Re-verified, no change to tracked fields
2023-04-05
Original filing
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.
Trial Details
NCT Number NCT05817942
Lead Sponsor Alfasigma S.p.A.
Conditions Ulcerative Colitis
Enrollment 509 participants
Start Date 2023-06-12
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-24