Proof of Concept Trial of Vamorolone in Pediatric Ulcerative Colitis

Summary

This is a Phase I/II, multi-center, open-label proof-of-concept study of vamorolone. Twenty participants with a flare of mild or moderately active Ulcerative Colitis (defined as a Pediatric Ulcerative Colitis Activity Index \[PUCAI\] 10-60) will be enrolled and receive vamorolone 6 mg/kg/day orally once daily for 8 weeks.

Timeline

Start

2020-09-01

Primary completion

2022-09-01

Completion

2022-09-01

Drugs

Indications