A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis
ConditionUlcerative Colitis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age8-18
SponsorAlfasigma S.p.A.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject must have a minimum body weight (BW) of 15 kg.
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Filgotinib
DrugIP 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).
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: FilgotinibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy of filgotinib in induction of remission and maintenance of effect in pediatric subjects with ulcerative colitis (UC)
Proportion of subjects achieving clinical remission based on modified Mayo Clinical Score (mMCS)
Time frame
Week 102
subjects with ulcerative colitis (UC)
Proportion of subjects achieving clinical remission based on mMCS
Time frame
Week 58Secondary outcomes
1
Safety and tolerability of filgotinib in pediatric subjects with UC
Incidence of treatment-emergent adverse events (TEAEs), adverse events of interest, and laboratory abnormalities through follow-up
Time frame
Week 622
Safety and tolerability of filgotinib in pediatric subjects with UC
Change from baseline in body mass index (BMI)
Time frame
Week 583
Safety and tolerability of filgotinib in pediatric subjects with U
Change from baseline in height velocity
Time frame
Week 58Sponsors and contacts
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Source ClinicalTrials.gov