Early Vedolizumab as First-Line for Immune-Related Colitis Therapy Trial

Conditions

• Immune Checkpoint Inhibitor-Related Colitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Vedolizumab 300 MG Injection [Entyvio] — DRUG
  This is a biologic medication to treat colitis
• Prednisone (and methylprednisolone) — DRUG
  This is a steroid
• Prednisone Taper — DRUG
  This is a tapering dose of prednisone
• Placebo Prednisone Capsules — OTHER
  Placebo for Prednisone
• Placebo Vedolizumab — OTHER
  Placebo for Vedolizumab
• Sulfamethoxazole-Trimethoprim — OTHER
  Antibiotic if on \>21 days of steroids
• Placebo for Sulfamethoxazole-Trimethoprim — DRUG
  Placebo for antibiotic (Sulfamethoxazole-Trimethoprim) Antibiotic. Only if on \>21 days of prednisone/placebo

Study Details

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

Key Dates

Start date

Jul 15, 2025

Status verified

Nov 2025

Primary completion

Jul 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Vedolizumab and Short Course of Steroids
  Participants in this arm will receive Vedolizumab infusions (3 doses) and steroids for 10 days (intravenous Medrol daily for 3 days and Prednisone daily for 7 days). Participants may also receive daily placebo (for Prednisone and Sulfamethoxazole-Trimethoprim).
• Active Comparator: Standard Course of Steroids
  Participants in this arm will receive steroids for 10 days (intravenous Medrol daily for 3 days and Prednisone daily for 7 days), followed by a steroid (Prednisone) taper. Participants may also receive Sulfamethoxazole-Trimethoprim (an antibiotic). Participants will receive 3 placebo infusions.

Primary Outcome Measure

Steroid-free remission rate [ Time Frame: 8 weeks ]

Central Contacts

• Shilpa Grover, MD, MPH
  6177326389
  [email protected]
• Seonyoung Goo
  [email protected]

Locations (2)

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