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Proof of Concept Trial of Vamorolone in Pediatric Ulcerative Colitis

NCT04348890 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2020-09-29

No results posted yet for this study

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

DRUG

Vamorolone 4% suspension for oral dosing

vamorolone 6 mg/kg/day orally once daily for 8 weeks.

Sponsors & Collaborators

  • ReveraGen BioPharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Laurie Conklin, MD · ReveraGen BioPharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-09-01
Completion
2022-09-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04348890 on ClinicalTrials.gov