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New study checks if filgotinib keeps ulcerative colitis in check Long-Term

NCT ID NCT05817942

Disease control Sponsor: Alfasigma S.p.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 509 adults with moderate to severe ulcerative colitis who are starting filgotinib, a drug also known as Jyseleca. Researchers want to see how long people stay on the treatment, how well it controls symptoms, and how it affects quality of life in everyday medical practice. The study is observational, meaning it watches what happens without changing how doctors prescribe the drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Filgotinib (Jyseleca)
What this could lead to
If successful, this study could confirm that filgotinib is an effective long-term treatment option for managing ulcerative colitis symptoms and improving quality of life.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. It also only includes people already starting filgotinib, which may limit how well findings apply to others.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

509 people

The number who actually took part.

Started

Jun 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

Contacts and locations

Locations

  • AKH - Medizinische Universität Wien

    Vienna, 1090, Austria

  • ASST Fatebenefratelli Sacco

    Milan, 20157, Italy

  • AZ Damiaan

    Ostend, 8400, Belgium

  • AZ Maria Middelares

    Ghent, 9000, Belgium

  • AZ Sint-Lucas

    Ghent, 9000, Belgium

  • Akershus Universitetssykehus

    Lørenskog, 1478, Norway

  • Amsterdam UMC (AMC)

    Amsterdam, 1105 AZ, Netherlands

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

    Palermo, 90146, Italy

  • Azienda Ospedaliera Saverio De Bellis - Castellana Grotte

    Bari, Italia, 70013, Italy

  • Azienda Ospedaliero Universitaria Pisana - Cisanello

    Pisa, Italia, 56124, Italy

  • Beaumont Hospital

    Dublin, D09 A0HK, Ireland

  • Bury Care Organisation

    Bury, BL97TD, United Kingdom

  • Bærum Hospital , Gjettum

    Oslo, 1346, Norway

  • CHRU de Nancy

    Nancy, 54000, France

  • CHU Amiens - Hopital Sud

    Amiens, 80000, France

  • CHU Bordeaux - Hôpital Haut-Lévêque

    Pessac, 33604, France

  • CHU Lille - Hôpital Claude Huriez

    Lille, 59000, France

  • CHU Montpellier- Hôpital Saint Eloi

    Montpellier, 34090, France

  • CHU Nantes - Hôtel Dieu

    Nantes, 44093, France

  • CHU Saint Etienne - Hôpital Nord

    Saint-Etienne, 42055, France

  • CHU Saint-Pierre

    Brussels, 1000, Belgium

  • CHU de Grenoble - Hôpital Nord

    Grenoble, 38043, France

  • CHU de Liège

    Liège, 4000, Belgium

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Clinique Abroise Paré

    Clichy, 92200, France

  • Clinique CHC MontLégia

    Liège, 4000, Belgium

  • Cliniques Universitaires de Bruxelles Hopital Erasme

    Brussels, 1070, Belgium

  • Cork University Hospital

    Cork, T12 DFK4, Ireland

  • ETZ Elisabeth

    Tilburg, 5022 GC, Netherlands

  • Erasmus MC

    Rotterdam, 3015 GD, Netherlands

  • Fachinternistische Schwerpunktpraxis

    Hamburg, 22041, Germany

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Franciscus Gasthuis

    Rotterdam, 3045 PM, Netherlands

  • Gastro Campus Research GbR

    Münster, 48159, Germany

  • Glasgow Royal Infirmary

    Glasgow, G40SF, United Kingdom

  • Hospital Clinic de Barcelona, C/ Villarroel, 170

    Barcelona, Spain, 08036, Spain

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Spain, 08916, Spain

  • Hospital Universitari Son Espases

    Palma de Mallorca, Spain, 07120, Spain

  • Hospital Universitario de Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria, Spain, 35012, Spain

  • Hospital Universitario de Santiago de Compostela

    Santiago de Compostela, Spain, 15706, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08025, Spain

  • Hôpital Jean Minjoz

    Besançon, 25000, France

  • Hôpital Rangueil

    Toulouse, 31059, France

  • Hôpital Saint-Louis

    Paris, 75010, France

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • IRCCS Ospedale Sacro Cuore Don Calabria

    Negrar, 37024, Italy

  • IRCCS Ospedale San Raffaele ,Via Olgettina 60

    Milan, Italia, 20132, Italy

  • Imeldaziekenhuis

    Bonheiden, 2820, Belgium

  • John Radcliffe Hospital

    Oxford, OX39DU, United Kingdom

  • KH der Barmherzigen Brüder St.Veit an der Glan

    Sankt Veit an der Glan, 9300, Austria

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, 9020, Austria

  • Klinikum St. Marien Amberg

    Amberg, 92224, Germany

  • LKH - Universitätsklinikum Graz

    Graz, 8036, Austria

  • Magen-Darm-Zentrum Remscheid

    Remscheid, 42859, Germany

  • Medizinisches Versorgungszentrum Dachau

    Dachau, 85221, Germany

  • Nordlandsykehuset

    Bodø, 8092, Norway

  • Norfolk and Norwich University Hospital

    Norwich, NR47UY, United Kingdom

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 AC, Netherlands

  • Oslo University Hospital

    Oslo, 0424, Norway

  • Ospedale Mauriziano Umberto I

    Torino, 10128, Italy

  • Praxis fur Gastroenterologie

    Heidelberg, 69115, Germany

  • Queen Elizabeth University Hospital

    Glasgow, G514TF, United Kingdom

  • Radboud UMC

    Nijmegen, 6525 GA, Netherlands

  • Royal Devon University Healthcare NHS Foundation trust

    Exeter, EX2 5DW, United Kingdom

  • Sint-Franciscus ziekenhuis

    Heusden-Zolder, 3550, Belgium

  • Southampton General Hospital

    Southampton, SO16 6YD, United Kingdom

  • St George's Hospital

    London, SW170QT, United Kingdom

  • St Mark's Hospital, Central Middlesex, Acton Lane

    London, NW10 7NS, United Kingdom

  • St Vincent's University Hospital

    Dublin, D04 T6F4, Ireland

  • St. Olav's University Hospital

    Trondheim, 7030, Norway

  • Synesis GmbH

    Grünwald, Bavaria, 82031, Germany

  • The Ulster Hospital

    Belfast, BT161RH, United Kingdom

  • UMC Utrecht

    Utrecht, 3584 CX, Netherlands

  • UZ Leuven

    Leuven, 3000, Belgium

  • UZA

    Edegem, 2650, Belgium

  • Universitaetsklinikum Schleswig-Holstein

    Kiel, 24105, Germany

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Universitetssykehuset Nord-Norge

    Tromsø, 9019, Norway

  • Universitätsklinikum Leipzig AöR

    Leipzig, 04103, Germany

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

  • Zuyderland Medisch Centrum - Sittard-Geleen

    Geleen, 6162 BG, Netherlands

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