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A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516199-14-00
Acronym
GS-US-418-3899
Enrollment
26
Registered
2024-09-03
Start date
2017-04-12
Completion date
Unknown
Last updated
2025-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis (UC)

Brief summary

Safety, evaluated through AEs, clinical laboratory tests, and vital signs

Detailed description

To evaluate the effect of filgotinib on partial Mayo Clinic Score (MCS)

Interventions

DRUGComposition apart from the active substance otherwise to identical to IMP

Sponsors

Alfasigma S.p.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Safety, evaluated through AEs, clinical laboratory tests, and vital signs

Secondary

MeasureTime frame
To evaluate the effect of filgotinib on partial Mayo Clinic Score (MCS)

Countries

Hungary

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026