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.
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…
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