drugset / Trial / NCT03849599

A Study to Evaluate the Safety of PRV-300 in Adult Subjects With Moderately to Severely Active Ulcerative Colitis

NCT03849599 ↗

Phase 1 Completed 37 enrolled Provention Bio, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the safety and tolerability of PRV-300 for 12 weeks in subjects with active ulcerative colitis. Subjects will receive either PRV-300 or placebo treatment. Each group will receive study drug over a total of 12 weeks, followed by an 8-week safety follow-up period.

Timeline

Start
2018-02-21
Primary completion
2019-03-01
Completion
2019-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject PRV-300 Unknown — Intravenous

Indications