eligibility_summary
Inclusion: age 6–17, moderate–severe UC ≥1 mo (PUCAI ≥30), failed/lost response/intolerant to steroids/IMMs (stable ≥2 wks), beyond rectum, Mayo ≥1, vaccines current. Exclusion: anti‑integrins, vedolizumab or infliximab, allergy, neuro disease/PML, needs surgery, colectomy/ostomy/stricture, unspecified/monogenic colitis, major comorbidity, Hgb≤8, WBC≤2.5×10^9/L, ALT/AST≥3×ULN, positive Quantiferon or stool pathogens. Monitoring: AEs/SAEs, infections (PML), liver injury, infusion reactions, vitals/labs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Vedolizumab vs infliximab, both intravenous monoclonal antibodies. Vedolizumab: humanized IgG1 anti-integrin biologic, binds α4β7 integrin on gut-homing T lymphocytes, blocking interaction with MAdCAM-1 on intestinal endothelium to reduce lymphocyte trafficking and gut-specific inflammation. Infliximab: chimeric IgG1 anti–TNF-α biologic, neutralizes soluble and transmembrane TNF-α, suppressing TNF-driven signaling (e.g., NF-κB), cytokine release, leukocyte recruitment, and inducing apoptosis of activated T cells/monocytes. Targeted cells/pathways: α4β7/MAdCAM-1 axis on T cells, TNF-α pathway in T cells/macrophages.