A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Diseas
The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC). The participants will be treated with vedolizumab for up to 34 weeks. Duri
| Condition(s) | Ulcerative Colitis, Crohn's Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC). The participants will be treated with vedolizumab for up to 34 weeks. During the study, participants will visit their study clinic several times. |
| Who can participate | Inclusion Criteria: 1. The participant weighs ≥10 kg at the time of screening and enrollment into the study. 2. Participants with UC or CD diagnosed at least 1 month before screening. Participants with moderately to severely active disease defined as: * Participants with UC: a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of ≥2 (with the presence of mucosal friability excluding an endoscopic subscore of 1 and mandating a score of at least 2). (The results of screening endoscopy should be applied.) * Participants with CD: a pediatric Crohn's disease activity index (PCDAI) \>30 and a simple endoscopic score for Crohn's disease (SES-CD) \>6 (or an SES-CD ≥4 if disease is confined to termi |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Lead sponsor | Takeda |
| Locations | Phoenix, Arizona, United States; Loma Linda, California, United States; Orange, California, United States; Palo Alto, California, United States; Park Ridge, Illinois, United States; Detroit, Michigan, United States (+48 more sites) |
| Start date | 2025-01-22 |
| NCT ID | NCT06100289 |
| Official listing | https://clinicaltrials.gov/study/NCT06100289 |