NCT04348890

Proof of Concept Trial of Vamorolone in Pediatric Ulcerative Colitis

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ReveraGen BioPharma, Inc. · Industry
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Vamorolone 4% suspension for oral dosing	vamorolone 6 mg/kg/day orally once daily for 8 weeks.

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2020-04-16
• Last updated: 2020-09-29

Regulatory

• FDA-regulated drug study