中等度から重度の潰瘍性大腸炎（UC）の小児および10代の若者を対象としたベドリズマブの研究

基本情報

NCT ID

NCT04779307

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

121

治験依頼者名

Takeda

概要

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease. The study is also evaluating side effects of vedolizumab in the children and teenager with moderately to severely active ulcerative colitis. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.

対象疾患

介入

依頼者（Sponsor）

実施施設 (5)