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RECRUITINGPhase 3INTERVENTIONAL

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

A Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Filgotinib, With Single Arm Induction and Maintenance, in Pediatric Subjects (8 to <18 Years of Age) With Moderately to Severely Active Ulcerative Colitis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Filgotinib

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. at approximately the same time every morning (with or without food).

Locations (20)

Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Brussels, Brussels Capital, Belgium
Centre Hospitalier Regional De La Citadelle
Liège, Liege, Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Namur, Namur, Belgium
Klinicki Bolnicki Centar Osijek
Osijek, Croatia, Croatia
Children's Hospital Zagreb
Zagreb, Croatia, Croatia
University Hospital Centre Zagreb
Zagreb, Croatia, Croatia
Hospital Femme Mere Enfant
Bron, France, France
Centre Hospitalier Universitaire De Dijon
Dijon, France, France
Hopital Saint Vincent de Paul - GHICL Lille
Lille, France, France
CHU de Montpellier
Montpellier, France, France
Centre Hospitalier Universitaire De Rennes
Rennes, France, France
Centre Hospitalier Regional Universitaire De Tours
Tours, France, France
Universitaetsklinikum Aachen AöR
Aachen, Germany, Germany
Universitaetsklinikum Leipzig AöR
Leipzig, Germany, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Mainz, Germany, Germany
Universitaetsklinikum Tuebingen AöR
Tübingen, Germany, Germany
Athens General Children's Hospital Panagioti And Aglaia Kyriakou
Athens, Greece, Greece
University General Hospital Attikon
Athens, Greece, Greece
General Hospital Of Thessaloniki Papageorgiou
Efkarpia, Greece, Greece
Hippokration Hospital
Thessaloniki, Greece, Greece