Early Vedolizumab as First-Line for Immune-Related Colitis Therapy Trial
연구 개요
The goal of this clinical trial is to compare the effectiveness and safety of Vedolizumab with a short course of steroids compared to standard course of steroids for the treatment of immune checkpoint inhibitor colitis (ICI colitis) in adults. The main questions it aims to answer are: * How many patients treated with Vedolizumab and a short course of steroids experience resolution of colitis at 8 weeks. * How many patients treated with a standard course of steroids experience resolution of colitis at 8 weeks. Participants will: Recieve 3 doses of Vedolizumab or a placebo (a look-alike substance that contains no drug) infusions over 6 weeks Receive intravenous Medrol daily for 3 days Receive Prednisone daily for 7 days Receive Prednisone or placebo taper daily Receive Sulfamethoxazole-Trimethoprim or placebo taper daily Weekly checkups and periodic tests
- 스폰서
- 협력: 다케다
- 적응증
- Immune Checkpoint Inhibitor-Related Colitis
- 중재
- Vedolizumab 300 MG Injection [Entyvio], Prednisone (and methylprednisolone), Prednisone Taper, Placebo Prednisone Capsules, Placebo Vedolizumab, Sulfamethoxazole-Trimethoprim, Placebo for Sulfamethoxazole-Trimethoprim
- 목표 등록
- 80명
- 시작일
- 2025-07-15
- 완료(예정)
- 2026-12-31
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