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Observational study on the effectiveness and safety of filgotinib for ulcerative colitis

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

Observational Alfasigma S.p.A. · NCT05817942

This study is testing how well filgotinib works and how safe it is for people with moderate to severe ulcerative colitis who are just starting treatment.

Quick facts

Study typeObservational
Enrollment600 (estimated)
Ages18 Years and up
SexAll
SponsorAlfasigma S.p.A. Industry-sponsored
Drugs / interventionsFilgotinib
Locations81 sites (Graz and 80 other locations)
Trial IDNCT05817942 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness, treatment patterns, quality of life, and safety of filgotinib in patients with moderately or severely active ulcerative colitis in a real-world setting. Participants will be filgotinib-naïve individuals who are starting treatment according to local guidelines. The study will collect data on patient outcomes and experiences to better understand the drug's impact in everyday clinical practice.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with moderately or severely active ulcerative colitis who have not previously received filgotinib.

Not a fit: Patients with Crohn's disease or those currently participating in other interventional studies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of filgotinib for patients with ulcerative colitis.

How similar studies have performed: Other studies have shown promising results with filgotinib for ulcerative colitis, indicating a potential for success in this observational approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Graz and 80 other locations

+31 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ulcerative Colitisfilgotinibsafetyefficacy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.