A Phase 2 Randomized Double-Blind Dose-Ranging Study to Determine the Pharmacokinetics Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
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- STATUS
- Not Recruiting
Summary
A safe and effective dose for vedolizumab in children has yet to be determined. The aim of this phase 2 dose-ranging study is to evaluate vedolizumab PK in male and female pediatric subjects with moderately to severely active UC or CD. In addition, the dose-response at Week 14 in these subjects will be characterized to aid in dose selection for the pediatric phase 3 studies. PK, efficacy (including endoscopic assessment at Week 14), and safety assessments will be performed during the 22-week study.
Description
A safe and effective dose for vedolizumab in children has yet to be determined. The aim of this phase 2 dose-ranging study is to evaluate vedolizumab PK in male and female pediatric subjects with moderately to severely active UC or CD. In addition, the dose-response at Week 14 in these subjects will be characterized to aid in dose selection for the pediatric phase 3 studies. PK, efficacy (including endoscopic assessment at Week 14), and safety assessments will be performed during the 22-week study.
Details
| Condition | ulcerative colitis,Crohn's disease |
|---|---|
| Age | 100years or below |
| Clinical Study Identifier | TX8584 |
| Last Modified on | 19 February 2024 |
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