NCT06841705View on ClinicalTrials.gov

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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

February 25, 2025

Primary Completion Date

July 30, 2026

Study Completion Date

December 31, 2026

Conditions
Immune Checkpoint Inhibitor-Related Colitis
Interventions
DRUG

Vedolizumab 300 MG Injection [Entyvio]

This is a biologic medication to treat colitis

DRUG

Prednisone (and methylprednisolone)

This is a steroid

DRUG

Prednisone Taper

This is a tapering dose of prednisone

OTHER

Placebo Prednisone Capsules

Placebo for Prednisone

OTHER

Placebo Vedolizumab

Placebo for Vedolizumab

OTHER

Sulfamethoxazole-Trimethoprim

Antibiotic if on \>21 days of steroids

DRUG

Placebo for Sulfamethoxazole-Trimethoprim

Placebo for antibiotic (Sulfamethoxazole-Trimethoprim) Antibiotic. Only if on \>21 days of prednisone/placebo

Trial Locations (1)

02115

Brigham and Women's Hospital, Boston

Sponsors

Collaborators (1)

Takeda
All Listed Sponsors
collaborator

Dana-Farber/Brigham and Women's Cancer Center

OTHER

collaborator

Takeda

INDUSTRY

lead

Shilpa Grover, MD, MPH

OTHER

NCT06841705 - Early Vedolizumab As First-Line for Immune-Related Colitis Therapy Trial | Biotech Hunter | Biotech Hunter