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New treatment option for Ulcerative Colitis
Official title A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis
ClinicalTrials.gov ID: NCT06865417
What this study is testing
What is Filgotinib?
Filgotinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ulcerative colitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 18
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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.
See the full eligibility 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 people who depend on corticosteroids to...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Brussels Capital, Belgium
- Liège, Liege, Belgium
- Namur, Namur, Belgium
- Osijek, Croatia, Croatia
- Zagreb, Croatia, Croatia
- Bron, France, France
- Dijon, France, France
- Lille, France, France
- Montpellier, France, France
- Rennes, France, France
- Tours, France, France
- Aachen, Germany, Germany
- Leipzig, Germany, Germany
- Mainz, Germany, Germany
- Tübingen, Germany, Germany
- Athens, Greece, Greece
- Efkarpia, Greece, Greece
- Thessaloniki, Greece, Greece
- Dublin, Ireland, Ireland
- Alessandria, Italy, Italy
+ 24 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Brussels Capital, Belgium; Liège, Liege, Belgium; Namur, Namur, Belgium; Osijek, Croatia, Croatia; Zagreb, Croatia, Croatia; Bron, France, France and 38 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.