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Looking for participantsPhase3

A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis

Sponsor: Alfasigma S.p.A.

NCT ID: NCT06865417

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Filgotinib (drug)
How long the study runs
Study runs about 33 months (dates as stated)
About the drug or intervention
Filgotinib — drug: IP will be provided as commercially developed film-coated tablets (100 and 200 mg strength) or reduced-strength (65 mg) age-appropriate film-coated tablets for use in pediatric subjects aged at least 8 years and needs to be taken orally q.d.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at the effects of a medicine called filgotinib in children and teenagers with ulcerative colitis, a long-term condition causing inflammation in the bowel. It is run by the sponsor Alfasigma S.p.A. The registry information does not state the study design, so ask the trial team for details.

Who can take part

  • Weighs at least 15 kilograms
  • Has had ulcerative colitis diagnosed by a doctor for at least 3 months
  • Has active symptoms of ulcerative colitis, shown by certain scores for inflammation seen during an examination of the bowel, rectal bleeding, and how often they pass stool
  • Current medicines have not worked well enough, have stopped working, or caused problems — including corticosteroids (medicines that reduce inflammation), immunosuppressants (medicines that calm the immune system), and/or biologic therapy. This also includes children who need corticosteroids to control symptoms or whose condition gets worse when lowering the dose

Who may not be able to

  • Has inflammatory bowel disease that doctors cannot clearly classify, inflammation only in the lowest part of the bowel, or a very swollen, dangerous widening of the colon called toxic megacolon
  • Has an infection at the time of the study
  • Has had a serious case of shingles affecting many areas of skin, spreading widely, affecting the eye, or affecting the brain or nerves
  • Is currently having treatment for a long-term infection, such as pneumocystis, cytomegalovirus, herpes simplex, shingles, or atypical mycobacteria
  • Has had surgery to remove the bowel (colon) or a large amount of small bowel removed
  • Has psychological or thinking difficulties that might make taking part hard
  • Has taken a type of medicine called a Janus kinase inhibitor, or one that works in a similar way (for example tofacitinib, baricitinib, or upadacitinib)
  • Is pregnant or breastfeeding, or plans to become pregnant or breastfeed during the study

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team about study visits, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
8 Years to 18 Years
Who
All
Number of participants
80
Started
2025-09-29
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for ulcerative colitis
  • • Phase3 - 80 participants
  • • The aim of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of filgotinib as a treatment for UC in children and adolescents aged from 8 to less than 18 years

Who can take part?

  • • Ages 8 Years to 18 Years
  • • Diagnosed with ulcerative colitis

Where?

  • • Bristol - Bristol Royal Infirmary
  • • Glasgow - Ninewells Hospital
  • • Liverpool - Alder Hey Children's Hospital
  • • London - Chelsea and Westminster Hospital
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The aim of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of filgotinib as a treatment for UC in children and adolescents aged from 8 to less than 18 years. Approximately 80 subjects from 8 to \<18 years of age with moderately to severely active UC, including a minimum of 8 subjects from 8 to \<12 years of age, will be enrolled in this study. During the study, eligible subjects will take the investigational product (IP) on-site at Week 4, Week 10, and Week 22 (in the morning; with or without food). On all other days, subjects will take IP at home (in the morning; with or without food). Subjects who do not achieve mMCS remission and/or MCS response at Week 10 will continue with induction treatment until Week 22. Subjects who do not achieve PUCAI remission at Week 22 will be permanently discontinued from the study. Subjects will all receive a filgotinib dose targeting the same systemic exposure as that observed in adults with UC treated with 200 mg q.d.

Ulcerative Colitis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 8 Years - 18 Years
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ a minimum body weight (BW) of 15 kg

What the study is looking for

  • ✓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,

Who cannot take part

  • ✗Subject has a diagnosis of inflammatory bowel disease -unclassified or indeterminate colitis, isolated proctitis, or...
  • ✗Subject has an active infection.
  • ✗Subject with a history of complicated herpes zoster infection (with multi-dermatomal, disseminated, ophthalmic, or...
  • ✗Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex, herpes...
  • ✗Subject has a history of colectomy or extensive small bowel resection.
See the full criteria
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.

Where Is This Study? (6 UK sites)

Bristol Royal Infirmary

Bristol BS2 8HW, United Kingdom

Recruiting
Site contact (verified)

Ninewells Hospital

Glasgow G51 4TF, United Kingdom

Recruiting
Site contact (verified)

Alder Hey Children's Hospital

Liverpool, United Kingdom

Recruiting
Hospital R&D contact (matched)

Kelly Davies

research@alderhey.nhs.uk0151 2525570

Chelsea and Westminster Hospital

London SW10 9NH, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

The Newcastle upon Tyne Hospital FT

Newcastle NE1 4LP, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Research and Development

nuth.genericqueries@nhs.net0191 282 4926

Sheffield Children's Hospital

Sheffield S10 2TH, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Vincenzo Teneggi, MD

Sponsor contact

CONTACT

00800 7878 1345 vincenzo.teneggi@external.alfasigma.com

Alexandra Mangili, MD

Sponsor contact

CONTACT

+041 795865622 alexandra.mangili@alfasigma.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08