Proof of Concept Trial of Vamorolone in Pediatric Ulcerative Colitis

Pediatric Ulcerative Colitis Clinical Trial

Official title:
A Phase I/II Open-Label, Proof-of-Concept Study of Vamorolone in Children and Adolescents With Mild-Moderately Active Ulcerative Colitis

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04348890
Study type	Interventional
Source	ReveraGen BioPharma, Inc.
Contact
Status	Withdrawn
Phase	Phase 1/Phase 2
Start date	September 1, 2020
Completion date	September 1, 2022

View Details

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