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New drug trial aims to tame gut disease in kids

NCT ID NCT06865417

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This study tests a daily pill called filgotinib in 80 children aged 8 to 17 with moderate to severe ulcerative colitis, a chronic gut disease. The goal is to see if the drug can reduce inflammation and help children feel better. All participants receive the drug, and the study tracks remission rates and side effects over time.

What this could mean

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

Active substance
filgotinib (a drug taken as a tablet once daily)
What this could lead to
If successful, this could provide a new treatment option for children with ulcerative colitis that helps control the disease and reduce symptoms.
What could go wrong
This is a single-arm study with no placebo group, so results may be less definitive. The drug may cause side effects, and not all children may respond.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jun 2028

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.

Ages

8 to 18 years

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: * Subject must have a minimum body weight (BW) of 15 kg. * Subject: * has documented diagnosis of UC with a minimum duration of 3 months, * has mMCS of 5 to 9, and an MCS endoscopic score \>=2, rectal bleeding \>=1, and stool frequency \>=1, * has had an inadequate response, loss of response, intolerance, or has medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy. This includes subjects who depend on corticosteroids to control their symptoms and who experience worsening of their disease when attempting to wean off corticosteroids. Exclusion Criteria: * Subject has a diagnosis of inflammatory bowel disease -unclassified or indeterminate colitis, isolated proctitis, or toxic megacolon. * Subject has an active infection. * Subject with a history of complicated herpes zoster infection (with multi-dermatomal, disseminated, ophthalmic, or central nervous system involvement). * Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex, herpes zoster, or atypical mycobacteria). * Subject has a history of colectomy or extensive small bowel resection. * Subject with psychological or cognitive difficulties that might interfere with study participation. * Subject has any previous exposure to a Janus kinase inhibitor or medication with a similar mode of action (e.g. tofacitinib, baricitinib, upadacitinib). * Female subject is pregnant or breast feeding or intending to become pregnant or breastfeed during the study.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    47 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASST Fatebenefratelli Sacco

    RECRUITING

    Milan, Italy, 20154, Italy

  • Alder Hey Children's Hospital

    RECRUITING

    Liverpool, United Kingdom

  • Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola

    NOT_YET_RECRUITING

    Brussels, Brussels Capital, 1020, Belgium

  • Athens General Children's Hospital Panagioti And Aglaia Kyriakou

    NOT_YET_RECRUITING

    Athens, Greece, 11527, Greece

  • Azienda Ospedaliera Universitaria Federico II Di Napoli

    RECRUITING

    Naples, Italy, 80131, Italy

  • Azienda Ospedaliero Universitaria dell Marche I G M Lancisi G Salesi

    RECRUITING

    Ancona, Italy, 60123, Italy

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I

    RECRUITING

    Rome, Italy, 00161, Italy

  • Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo

    RECRUITING

    Alessandria, Italy, 15121, Italy

  • Bristol Royal Infirmary

    RECRUITING

    Bristol, BS2 8HW, United Kingdom

  • CCAB Centro Clinico Academico Braga Associacao

    RECRUITING

    Braga, Portugal, 4710-243, Portugal

  • CHU de Montpellier

    RECRUITING

    Montpellier, France, 34295, France

  • Centre Hospitalier Regional De La Citadelle

    NOT_YET_RECRUITING

    Liège, Liege, 4000, Belgium

  • Centre Hospitalier Regional Universitaire De Tours

    RECRUITING

    Tours, France, 37000, France

  • Centre Hospitalier Universitaire De Dijon

    RECRUITING

    Dijon, France, 21000, France

  • Centre Hospitalier Universitaire De Rennes

    RECRUITING

    Rennes, France, 35200, France

  • Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur

    RECRUITING

    Namur, Namur, 5000, Belgium

  • Chelsea and Westminster Hospital

    NOT_YET_RECRUITING

    London, SW10 9NH, United Kingdom

  • Children's Health Ireland

    NOT_YET_RECRUITING

    Dublin, Ireland, D12 PN40, Ireland

  • Children's Hospital Zagreb

    RECRUITING

    Zagreb, Croatia, 10000, Croatia

  • Dr. Victor Gomoiu Clinical Children Hospital

    RECRUITING

    Bucharest, Romania, 022102, Romania

  • Gabinet Lekarski Bartosz Korczowski

    RECRUITING

    Rzeszów, Poland, 35-302, Poland

  • General Hospital Of Thessaloniki Papageorgiou

    RECRUITING

    Efkarpia, Greece, 56429, Greece

  • Hippokration Hospital

    RECRUITING

    Thessaloniki, Greece, 54642, Greece

  • Hopital Saint Vincent de Paul - GHICL Lille

    RECRUITING

    Lille, France, 59020, France

  • Hospital Femme Mere Enfant

    RECRUITING

    Bron, France, 69500, France

  • Hospital Germans Trias I Pujol

    RECRUITING

    Badalona, Spain, 08916, Spain

  • Hospital Pediátrico de Coimbra

    RECRUITING

    Coimbra, Portugal, 3000-602, Portugal

  • Hospital Universitario Reina Sofia

    RECRUITING

    Córdoba, Spain, Spain

  • IRCCS Materno Infantile Burlo Garofolo

    RECRUITING

    Trieste, Italy, 34137, Italy

  • In Vivo Sp. z o.o.

    RECRUITING

    Bydgoszcz, Poland, 85-048, Poland

  • Instytut Centrum Zdrowia Matki Polki

    RECRUITING

    Lodz, Poland, 93-338, Poland

  • Instytut Pomnik Centrum Zdrowia Dziecka

    RECRUITING

    Warsaw, Poland, 04-730, Poland

  • Klinicki Bolnicki Centar Osijek

    RECRUITING

    Osijek, Croatia, 31000, Croatia

  • Ninewells Hospital

    RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • Oslo University Hospital HF

    RECRUITING

    Oslo, Norway, 0372, Norway

  • Ospedale Pediatrico Bambino Gesu

    RECRUITING

    Rome, Italy, 00165, Italy

  • Sheffield Children's Hospital

    RECRUITING

    Sheffield, S10 2TH, United Kingdom

  • Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara

    RECRUITING

    Timișoara, Romania, 300011, Romania

  • Sykehuset I Vestfold HF

    RECRUITING

    Tønsberg, Norway, 3116, Norway

  • The Newcastle upon Tyne Hospital FT

    NOT_YET_RECRUITING

    Newcastle, NE1 4LP, United Kingdom

  • Unidade Local De Saude Do Alto Minho E.P.E.

    RECRUITING

    Viana do Castelo, Portugal, 4904-858, Portugal

  • Universitaetsklinikum Aachen AöR

    RECRUITING

    Aachen, Germany, 52074, Germany

  • Universitaetsklinikum Leipzig AöR

    RECRUITING

    Leipzig, Germany, 04103, Germany

  • Universitaetsklinikum Tuebingen AöR

    RECRUITING

    Tübingen, Germany, 72076, Germany

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

    RECRUITING

    Mainz, Germany, 55131, Germany

  • University General Hospital Attikon

    RECRUITING

    Athens, Greece, 12462, Greece

  • University Hospital Centre Zagreb

    RECRUITING

    Zagreb, Croatia, 10000, Croatia

More trials for these conditions

Other studies related to the condition(s) this trial covers.