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Long-term safety of subcutaneous vedolizumab in pediatric ulcerative colitis and Crohn's disease (extension of VedolizumabSC-3003)
jRCT2031250519Phase 3Recruiting
- Sponsor
- Takeda
- Start
- Oct 2025
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
01
Overview
Phase 3, open-label trial of vedolizumab in autoimmune colitis and Crohn's disease (3 arms), sponsored by Takeda. Primary endpoints: Number of participants with adverse events (AEs) and serious adverse events (SAEs) in treatment cohort, Number of participants with adverse events of special interest (AESIs) in treatment cohort and 1 more. Started Oct 2025; status: recruiting.
02
Drugs
vedolizumab
03
Conditions
autoimmune colitisCrohn's disease
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