ClinicaliQ Trial Snapshot
- A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis — Recruiting • Phase III • Respiratory / COPD / Asthma • NCT06865417.
- Intervention being tested: Filgotinib, a JAK1-selective inhibitor, is being evaluated for efficacy, safety, tolerability, and pharmacokinetics in paediatric and adolescent patients with ulcerative colitis (UC), representing the first examination of this targeted immunosuppressive agent in this younger age group.
- Patient eligibility overview: The trial includes approximately 80 children and adolescents aged 8 to under 18 years with confirmed ulcerative colitis, addressing a significant gap in treatment options for this paediatric population where disease management remains clinically challenging.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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
Eligibility Snapshot
- : * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.