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

Recruiting Phase 3 Interventional Study
Ulcerative Colitis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
8 – 18
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Alfasigma S.p.A. · Industry
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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 s…
Trial Locations
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Eligibility 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 respon…
Contacts

Vincenzo Teneggi, MD

00800 7878 1345

vincenzo.teneggi@external.alfasigma.com

CONTACT

Alexandra Mangili, MD

+041 795865622

alexandra.mangili@alfasigma.com

CONTACT