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AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory value), symptom, or disease temporally associated with use of drug whether or not it is considered related to drug. 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Wu",{"type":749,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100547216","phase-3-a-long-term-extension-study-of-vedolizumab-in-children-and-teenagers-with-ulcerative-colitis-uc-or-crohns-disease-cd-100547216",false,"NCT06405087","A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)","A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease","Inclusion Criteria for Treatment Cohort 1. 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Has received at least 1 dose of vedolizumab during Study VedolizumabSC-3003 (NCT06100289) and early terminated OR completed the Week 34 clinic visit of Study VedolizumabSC-3003 (NCT06100289) but was not eligible to enroll in the treatment cohort of this study.\n\nExclusion Criteria for Treatment Cohort\n\n1. Has hypersensitivity or allergies to vedolizumab or any of its excipients.\n2. The participant currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.","ALL","2 Years","17 Years",{"count":761,"type":762},70,"ESTIMATED","INTERVENTIONAL",[765],"PHASE3","The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC.\n\nIn this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 \\[NCT06100289\\]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study.\n\nDuring the study, participants will visit their study clinic several times.",[768,769],"Ulcerative Colitis","Crohn's Disease",[771],"Drug Therapy","2026-10-08",{"date":774,"type":775},"2026-10-09","ACTUAL",{"date":777,"type":775},"2025-10-27",{"date":779,"type":762},"2030-08-12",{"name":5,"class":6},47]